comparison of two continuous passive motion regimes ... · due to the conflicting evidence about...
TRANSCRIPT
Comparison of Two Continuous Passive Motion
Regimens following Total Knee Arthroplasty
Bree Suzanne Evans
B Sc (Physiotherapy) (1st Class Honours)
This thesis is presented for the degree of
Master of Medical Science
of the
University of Western Australia
School of Surgery
Orthopaedics
2013
1
Abstract
This prospective randomised study compared the outcomes of patients undergoing
total knee arthroplasty who received a single intraoperative dose of local anaesthetic
and adrenaline and had different postoperative continuous passive motion (CPM)
protocols. 55 patients were randomised prior to surgery into two treatment groups. Nine
patients were excluded because they did not return for three month follow-up, six
patients were excluded because an epidural was commenced in theatre and two were
excluded because they did not receive the intra-articular injection. This left 18 patients
in Group A and 20 patients in Group B. Group A had 48 hours of continuous CPM and
Group B did not have routine CPM. If patients in Group B had less than 70 degrees of
active-assisted knee flexion they received one hour per day of CPM. Two patients in
group B required the CPM and the remaining 18 patients in Group B did not have any
CPM. At four days post-operatively Group B had significantly more knee extension then
Group A but at three months post-operatively there was no significant difference
between groups. At four days and three months post-operatively no significant
difference was found between groups in knee flexion or quadriceps lag. There was also
no significant difference between the two groups for length of stay, quality of life, need
for a manipulation under anaesthetic or requirement of a blood transfusion. The 48
hour CPM group had significantly more blood loss in the drain (p=0.009) and
experienced more pain measured by the need for an intervention on the ward due to
pain (p=0.036). These results show that continuous CPM for 48 hours had no
advantage in improving range of motion, length of stay or quality of life and that it
increased blood loss and caused more pain.
2
Table of Contents
Abstract 1
Acknowledgements 5
Main Text 6
1. Introduction 6
2. Literature Review 7
2.1. Introduction 7
2.2. CPM Post TKA 7
2.2.1. Knee Range of Motion 8
2.2.2. Quadriceps Lag 10
2.2.3. Manipulation Under Anaesthetic 11
2.2.4. Length of Stay 11
2.2.5. Quality of Life and Function 12
2.2.6. Blood Loss and Swelling 13
2.2.7. Pain 13
2.3. Analgesia Post TKA 14
2.3.1. Intra-Articular Injection 14
2.4. Conclusion 17
3. Method 17
3.1. Study Design 17
3.2. Subjects 17
3.3. Outcome Measures 18
3.4. Materials 18
3.5. Procedures 18
3.6. Ethical Considerations 22
3
3.7. Data Analysis 22
4. Results 22
4.1. Demographic Data 22
4.2. Active Knee Flexion 23
4.3. Active-Assisted Knee Flexion 23
4.4. Active Knee Extension 24
4.5. Quadriceps Lag 24
4.6. Manipulation Under Anaesthetic 25
4.7. Length of Stay 25
4.8. Quality of Life 25
4.9. Haemoglobin, Blood Loss and Blood Transfusion 26
4.10. Pain 26
4.11. Complications 27
5. Discussion 28
6. Conclusion 31
7. Tables
Table 1. Summary of CPM Journal Articles 32
Table 2. Demographics 36
Table 3. Age and Pre-operative BMI 36
Table 4. Knee ROM and Quadriceps Lag 36
Table 5. LOS, QOL, Haemoglobin and Blood Loss 37
Table 6. MUA, Blood Transfusion and Intervention
due to Pain 37
Table 7. Functional Activity Score (FAS) 37
Table 8. Visual Numeric Rating Scale 38
Table 9. Epidural Drug 38
4
Table 10. Number of Patients who had Oral Analgesia 38
Table 11. Dose of Fentanyl and Oxycodone IR 38
Table 12. Number of Patients who had
Anti-Inflammatories 39
8. Figures
Figure 1. Mean Active Knee Flexion 40
Figure 2. Mean Knee Extension 40
Figure 3. Mean Haemoglobin 41
Figure 4. Mean Blood Loss in Drains 41
Figure 5. Number of Interventions on Ward Due to Pain 42 Figure 6. Type of Intervention on Ward Due to Pain 42
9. References 43
Appendices
A. Patient Information Sheet 47
B. Patient Consent Form 49
C. Recruitment Flow Diagram 50
D. Functional Activity Score (FAS) 51
E. SF-36 Health Survey 52
F. Data Collection Sheet 56
G. Raw Data 58
H. Data Analysis 70
5
Acknowledgements
I would like to express my gratitude to the following people for their assistance and
support during this study:
The Hollywood Private Hospital Research Foundation for providing funding for this
study.
Professor David Wood and Mr Greg Janes, my supervisors, for their assistance,
support and advice.
Luke Bongiascia and Jessica Nolan for their assistance with data collection and the
treatment of patients.
Angela Jacques, Jacques Consulting Pty Ltd, for her statistical advice.
Dermot Murphy and Sinead O’Leary from the Acute Pain Service at Hollywood
Private Hospital for their guidance and advice.
Charlotte Foskett, my Manager, for allowing me to work flexible hours whilst
completing this study and my thesis.
And my husband, Mark, for his constant support, patience and assistance.
6
1. Introduction
There is conflicting evidence for and against the use of Continuous Passive Motion
(CPM) following total knee arthroplasty (TKA).1,2,3,4,5,6,7,8 In this particular facility alone
there are several different protocols for the use of CPM after Total Knee Arthroplasty
(TKA).
In one regimen currently advocated CPM is used continuously for the first two post
operative days, usually with epidural as the primary mode of post-operative analgesia.
However, epidurals are often associated with slower mobilisation9 from transient motor
and sensory blocks and hypotension.10,11
One of our alternative post operative regimens only employs CPM if active-assisted
knee flexion is less than 70 degrees after the first post operative day. These patients
receive one hour of CPM per day until they achieve 70 degrees active-assisted knee
flexion.
Recently, administration of intra-articular local anaesthetic with adrenaline has been
proposed as the primary mode of post-operative analgesia.12 Whilst this method
provides adequate initial pain relief, the duration of effect is insufficient to provide
effective pain control for the two days of constant CPM treatment. Consequently, some
patients require additional pain relief in the form of an epidural to complete the 48
hours of CPM treatment.
The aim of this study was to determine whether the amount of CPM affected outcomes
in patients who had a single dose intra-articular injection, performed intraoperatively, as
the primary mode of analgesia post TKA.
7
It was hypothesised that between the two treatment groups there would be no
difference with regard to flexion, extension, quadriceps muscle strength, blood loss,
need for manipulation under anaesthetic, length of stay, quality of life or pain.
2. Literature Review
2.1. Introduction
CPM is a mechanical device that passively moves a joint through a preset range of
motion. CPM machines were first used in the 1970s by Robert Salter.13 CPM may be
used as an adjunct to physiotherapy post TKA. There are many different CPM
protocols between hospitals and within hospitals between different surgeons. This is
due to the conflicting evidence about the benefits of CPM (Table 1).1,2,3,4,5,6,7,8
2.2. CPM Post TKA
A meta-analysis of 14 studies by Brosseau et al1 aimed to determine the effectiveness
of CPM post TKA. Active and passive knee range of motion, length of stay, pain,
swelling, fixed flexion deformity and quadriceps strength were the outcome measures
they compared.1 The experimental and control groups received physiotherapy and the
experimental group also had CPM treatment.1 The duration of CPM between the
studies varied from five hours to 20 hours of CPM per day.1 The 14 studies included a
total of 952 patients.1 Brosseau et al1 found the use of CPM compared to no CPM
significantly improved active knee flexion at two weeks postoperatively, reduced length
of stay and reduced the need for manipulation under anaesthetic. However, CPM did
not significantly improve passive flexion nor did it improve passive or active knee
extension.1 They suggested there is a need for further research to examine the
effectiveness of intensity and duration of treatment with CPM post TKA.1
Moderate short-term benefits of CPM post TKA but no long-term benefits were reported
by Lenssen5 who compared 15 studies. They defined short-term benefits as 7-14 days
8
after surgery and long-term benefits as 6-12 months after surgery.5 These studies
compared range of motion as the primary outcome measure.5
Grella3 concluded that there is no benefit of CPM on short and long term knee
extension, long-term knee flexion, pain, complications and length of stay but there is
conflicting data in regard to short-term flexion and quadriceps muscle strength. Grella3
also concluded that CPM was more likely to have an effect on outcomes if it was
applied immediately post-operatively, for a significant amount of time each day and
was at a high flexion angle.
Viswanathan and Kidd8 conducted a systematic review on the effectiveness of CPM
post TKA in improving range of motion and function. They examined nine studies and
concluded there may be short-term benfits of CPM on range of motion but not long-
term benfits and there was limited evidence supporting an improvement of function as
a result of CPM.8
The difference in evidence either supporting or rejecting the use of CPM explains the
varying CPM protocols that currently exist.
2.2.1. Knee Range of Motion
Many studies have failed to demonstrate a benefit in knee flexion when CPM is
employed in the postoperative period.13,14,15,16,17,18 Bennett2 and Pope7 reported a short-
term improvement in flexion but no long-term difference between patients who have
CPM and those that did not. Harms4 found CPM significantly improved knee flexion and
extension, but this was also only a short-term improvement.
Pope et al7 compared 48 hours of CPM to physiotherapy (Table 1). 7At one week post-
operatively, Pope et al7 found a significant increase in flexion and total range of motion
in the group who received CPM 0-70 degrees compared to the group who had no
9
CPM. However, at one year post-operatively there was no significant difference in
flexion, total range of motion or fixed flexion deformity between any of the groups.7
Beaupre et al14 conducted a randomised controlled trial comparing three post-operative
regimens post TKA in 120 subjects.14 In addition to physiotherapy, the first group
received CPM and the second group received slider board therapy 14 (Table 1). No
significant difference was demonstrated between the groups for knee range of motion
and concluded there was no benefit of using CPM or slider board therapy in addition to
physiotherapy post TKA.
Harms and Engstrom4 randomly assigned 113 patients from 11 orthopaedic surgeons
to a CPM and physiotherapy group or a physiotherapy only group (see Table 1).
Patients who received CPM and physiotherapy had greater knee flexion (p=0.005) and
extension (p=0.001) range of motion than those who received physiotherapy alone at
discharge.4 Harms and Engstrom4 did not perform follow-up beyond discharge, as a
result of which the results only pertain to the short term, rather than longer term
benefits.
Leach et al18 randomly assigned 55 patients to have CPM and physiotherapy or
physiotherapy alone post TKA (Table 1). No significant difference was found in knee
flexion or extension between the groups at any measurment interval and therefore
Leach et al18 concluded that CPM does not influence range of motion post TKA.
Bennett et al2 compared two CPM protocols to a third group with no CPM post TKA
(Table 1). Both CPM groups received the same physiotherapy as the no CPM group
and the CPMs were applied for three hours twice a day for five days in both groups.2
The group who received CPM 50-90 degrees had significantly greater knee flexion than
the other two groups on post-operative day five.2 Bennett et al2 concluded that they are
unable to justify the use of routine CPM post TKA as there are no long term benefits.
10
Lenssen et al6 randomly assigned 60 patients to one of two CPM groups. The first
group received CPM for the first 17 days post-operatively and the second group
received CPM for the first four days post-operatively.6 Both groups had CPM for two
hours twice daily to a range as high as tolerated.6 Lenssen et al6 found no difference in
range of motion between the groups at six weeks or three months post-operatively
(Table 1).
Denis et al17 compared CPM for 35 minutes daily to CPM for two hours daily to no CPM
and found there was no significant difference between the three groups in active knee
flexion or extension at discharge. The CPM angle was started at 0-35 degrees and
increased daily as tolerated (Table 1).17 Chen et al16 found no significant difference in
passive range of motion at discharge when comparing five hours per day of CPM to
patients who had no CPM (Table 1).
Bruun-Olsen et al15 found “CPM had no additional effect compared to active exercises
alone on knee range of motion at one week or three months after TKA”. They
compared patients who had physiotherapy alone to patients having physiotherapy and
CPM (Table 1).15 The CPM was applied at an angle of 70-100 degrees for 2 hours
twice on the day of surgery and for 2 hours three times on post-operative day one at an
angle of 0-100 degrees.15
Despite the range of CPM angles and durations which have been studied the only
benefits that CPM may have on range of motion is an improvement in short-term knee
flexion. Based on current literature CPM does not have an influence on knee extension
or long-term knee flexion.
2.2.2. Quadriceps Lag
Few studies have assessed quadriceps lag post TKA when comparing CPM protocols.
Bennett et al2 compared two CPM protocols to a third group with no CPM post TKA and
11
found no significant difference between the groups for quadriceps lag on post-operative
day five, three months or one year post-operatively (see Table 1). There is currently no
evidence comparing continuous CPM to no CPM where quadriceps lag is an outcome
measure.
2.2.3. Manipulation Under Anaesthetic
When a patient does not reach an adequate knee flexion angle following a TKA a
manipulation under anaesthetic is sometimes performed. Most studies comparing CPM
to no CPM post TKA have used knee flexion and range of motion as outcome
measures and not the number of patients requiring a manipulation under anaesthetic.
Alkire and Swank13 compared 33 patients who received CPM and physiotherapy post
TKA to 32 patients who received physiotherapy alone. The CPM group had two hours
of CPM, three times a day on the day of surgery and post-operative day one and two.13
The CPM started at 70-90 degrees in recovery and the extension was increased by 10
degrees over four hours (see Table 1).13 Alkire and Swank13 reported two patients in
each group required a manipulation under anaesthetic.
2.2.4. Length of Stay
Several studies have assessed the effect of CPM on length of stay post TKA. An
increase in length of stay reflects a higher cost of patient care and is therefore an
important outcome following TKA. The patients in the CPM group in Alkire and
Swank’s13 study had a mean length of stay of 2.3 days and the no CPM group had a
mean length of stay of 2.24 days, there was no significant difference between groups
(Table 1).
Bennett et al2 compared CPM for three hours, twice a day for the first five post-
operative days to no CPM. The angle for the first group was 0-40 degrees with an
increase of 10 degrees per day, this group had a mean length of stay of 8.8 days.2 The
12
second group had CPM 50-90 degrees with extension increased by 20 degrees per
day and had a mean length of stay of 8.1 days.2 The final group had no CPM and had a
mean length of stay of 8.0 days.2 Bennett et al2 reported no difference between groups
for length of stay (p=0.51).
Finally, Denis et al17 compared CPM for 35 minutes daily to two hours daily to no CPM
(Table 1). Denis et al17 recorded the real length of stay but also recorded the theoretical
length of stay. Some patients had their discharge delayed due to social circumstances
so the theoretical length of stay was when the patient met all criteria for discharge.17
The discharge criteria included independence with transfers and ambulation with
walking aids, independence negotiating stairs, approximately 75 degrees of active knee
flexion and appropriate would healing.17 The ‘no CPM’ group had a mean real length of
stay of 7.8 days, the 35 minute CPM group had a mean real length of stay of 8.1 days
and the two hour CPM group had a mean real length of stay of 8.0 days.17 The mean
theoretical length of stays for the ‘no CPM’ group, 35 minute CPM group and the two
hour CPM group were 7.5 days, 7.9 days and 7.6 days, respectively.17 Denis et al17
found no significant difference between the three groups for real or theoretical length of
stay.
The varying durations and angles of CPM in these three studies suggest that CPM
appears to have no influence on length of stay post TKA regardless of the CPM
parameters. Length of stay is often influenced by a number of other factors such as
social circumstances17 and the pre-operative expectations of the patient and the
surgeon.
2.2.5. Quality of Life and Function
One reason for patients to decide to have a TKA is to improve their quality of life. It is
therefore important when examining CPM protocols to assess quality of life as an
outcome measure. Many of the studies already discussed have assessed quality of
13
life2,14 or function2,7,13 and have not demonstrated a difference between patients who
have CPM and those who have no CPM post TKA (see Table 1). Beaupre et al14 used
the Western Ontario and McMaster Univiersities (WOMAC) Osteoarthritis Index and
the Short-Form Health Survey (SF-36) to assess quality of life post knee arthroplasty
and found no difference between groups.
2.2.6. Blood Loss and Swelling
Many studies have assessed blood loss and/or swelling post TKA when evaluating the
effectiveness of CPM. Harms and Engstrom4 found no significant difference in wound
drainage when comparing patients receiving no CPM to those having CPM (Table 1).
Pope et al7 was the only study to assess blood loss via the drain when continuous CPM
was applied (Table 1). They found patients who had continuous CPM, for a minimum of
20 hours per day, had more blood loss via the drain than those who had no CPM
(p=0.008).7 Pope et al7 emphasised the importance of minimising blood loss in an
attempt to avoid blood transfusions. While short duration CPM has not been shown to
influence blood loss there is a need for further research into the effect of long duration
or continuous CPM on blood loss.
Alkire and Swank13, Bruun-Olsen et al15 and Chen et al16 all found no significant
difference in post-operative swelling, measured by circumference, between patients
who have CPM and those who have no CPM. Alkire and Swank13 reported slightly less
drainage in patients who had no CPM but this did not reach significance.
2.2.7. Pain
Several studies that have compared CPM for one hour twice a day18 or two hours,
three times per day13,15 to patients who have no CPM have shown no difference in pain
post TKA. Pope et al7 found a significant increase in the requirement for analgesia in
patients with CPM compared to those having no CPM (Table 1). The authors
14
concluded that this increase in requirement of analgesia may result in an increase in
nursing time and therefore increase in cost of patient care.7
2.3. Analgesia Post TKA
Traditionally epidurals, patient controlled analgesia (PCA) and peripheral nerve blocks
have been the most common modes of analgesia after lower limb arthroplasty.9
However, side effects such as nausea, sedation, hypotension, urinary retention and
motor block are associated with these modes of analgesia.11 Common side effects from
PCAs include sedation, nausea and pruritus and are associated with the opioids
used.10 Epidurals are associated with increased side effects when compared to
peripheral nerve blocks.19,20 Side effects of epidurals can include hypotension, urinary
retention, motor and sensory block and epidural haematoma.10,11 Patients who have a
peripheral nerve block also have an increased risk of developing heel pressure areas21
and may be slower to mobilise due to motor and sensory blocks11. Corbett et al22
compared the removal of the epidural catheter on postoperative day one to
postoperative day two in patients following TKA and found the group who had the
epidural removed on postoperative day one had a significantly lower length of stay and
ambulated a significantly greater distance on the second postoperative day.
2.3.1. Intra-Articular Injection
Recent research supports the use of intra-articular analgesia as a primary mode of
analgesia after TKA.9,11,12,23,24 This mode of analgesia improves early pain management
and mobilisation for patients after a TKA compared to a femoral nerve block.11
Toftdahl et al11 randomly assigned 80 patients to receive either a continuous femoral
nerve block or peri- and intra-articular infiltration and injections post TKA. The 40
patients in the intra-articular group received an infiltration of ropivacaine, ketorolac and
adrenaline intra-operatively followed by two further injections at 10pm on the day of
surgery and by 10am the following day.11 There was no significant difference in pain
15
scores between the two groups on post-operative day one at rest but the intra-articular
group had significantly lower pain scores on post-operative day one during
physiotherapy.11 The patients in the intra-articular group also had lower consumption of
opioids on post-operative day one (p=0.02).11 Walking distance and quadriceps
function were significantly higher in the intra-articular group than the femoral nerve
block group on post-operative day one and two.11 There was no significant difference
between the groups in side effects experienced post-operatively.11 These results
support the use of intra-articular infiltration rather than a continuous femoral nerve
block post TKA.
Thorsell et al9 compared 65 patients who randomly received either an epidural or intra-
articular injection post TKA. Their outcome measures included morphine consumption,
range of motion, walking ability, patient satisfaction, length of stay and time in the
recovery room.9 The 33 patients in the intra-articular injection group were given a
mixture of ropivacaine, adrenaline and ketorolac.9 Thorsell et al9 found no significant
difference between the two groups in length of stay, range of motion or morphine
consumption. The patients in the intra-articular injection group mobilised faster
(p<0.001) than the epidural group and were more satisfied with their post-operative
pain control (p=0.03).9 Thorsell et al9 concluded that intra-articular injection is superior
to epidural in the control of post-operative pain post TKA and they have changed their
clinical practice as a result.
Andersen et al23 randomly assigned 40 patients undergoing a TKA to either receive a
peri- and intra-articular infiltration and infusion or a continuous epidural infusion. The
intra-operative wound infiltration included ropivacaine, ketorolac and adrenaline and
the intra-articular infusion included ropivacaine and ketorolac.23 The epidural infusion
included ropivacaine and ketorolac.23 The group who had the peri- and intra-articular
infusion had less morphine consumption (p=0.01) and significantly lower pain scores at
rest and with mobilisation for the first 48 hours compared to the epidural group.23
16
Ong et al24 conducted a randomised control trial to determine if continuous infiltration of
local anaesthetic can reduce pain and morphine consumption post TKA. They assigned
17 patients to the control group who received a patient controlled analgesia (PCA) with
intravenous morphine for the first 48 hours post-operatively.24 The second group had
16 patients and received a continuous infiltration of bupivacaine to the subcutaneous
tissue and intra-articular space for 48 hours and these patients also had a PCA.24 The
final group of 21 patients received an intra-articular injection of ketorolac, morphine,
bupivacaine and normal saline and then had the same continuous infiltration of
bupivacaine for 48 hours as the second group and also had a PCA.24 The patients in
the control group had significantly higher pain scores measured by the visual analogue
pain score and had significantly higher morphine use than the two infiltration groups.24
Ong et al24 suggested continuous infiltration of local anaesthetic should be used as an
adjunct to PCA post TKA.
Fajardo et al12 performed a prospective randomised study in 30 patients having
bilateral total knee arthroplasties. The patients randomly had an intra-articular injection
of ketorolac, morphine, bupivacaine and adrenaline injected into one knee and a
placebo injected into the other knee.12 There was higher range of motion on post-
operative day four in the knee which received the intra-articular injection compared to
the knee which received the placebo injection (p<0.05).12 Fajardo et al12 also reported
patients had less pain in the treatment knee than the placebo knee (p<0.05).
In conclusion, recent evidence supports the use of intra-articular analgesia in
conjunction with a PCA post TKA rather than an epidural, peripheral nerve block or
PCA alone.
17
2.4. Conclusion
Although the effectiveness of CPM has previously been studied there is a need to
research its effectiveness in combination with an intra-articular injection. There is
currently no literature comparing the use of continuous CPM to intermittent or no CPM
when a single-dose injection of intra-articular local anaesthetic with adrenalin is used
as the primary mode of post-op analgesia.
3. Method
3.1. Study Design
This prospective, randomised study compared two CPM regimens.
3.2. Subjects
From December 2008 until June 2010, patients undergoing a unilateral primary TKA for
osteoarthritis by one of the two orthopaedic surgeons involved in the study were
considered for inclusion. Only patients who were planned to receive a single-dose
intra-articular injection as the primary mode of analgesia were included in the study.
Exclusion criteria consisted of the inability to provide informed consent, previous major
surgery to the knee, neuropathic or sensory disorders in the lower limb to be operated
on, patients living outside the metropolitan area, patients over 80 years of age and
patients who had complications post-operatively which prevented routine
physiotherapy. Of 55 patients who were included in the study, nine patients were
excluded because they did not return for three month follow-up, six patients were
excluded because they had an epidural commenced in theatre and two were excluded
because they did not receive the intra-articular injection. All subjects who participated
in the study read a Patient Information Sheet (see Appendix A) and signed an Informed
Consent Form (see Appendix B) prior to participating in the study.
18
The patients were randomised prior to surgery into two treatment groups using a
random number table. There were 18 patients in Group A and 20 patients in Group B.
Group A had a CPM protocol consisting of two days continuous CPM, the first 24 hours
the CPM was cycling from 70-90 degrees and the second 24 hours was cycling from 0-
90 degrees. Group B did not have routine CPM but they had one hour per day of CPM
if the active-assisted knee flexion was less than 70 degrees, starting on post-operative
day one. Of the nine patients who did not return for three months follow-up, four were
in Group A and five were in Group B (see Appendix C).
3.3. Outcomes
The primary outcome measure was active knee flexion. Secondary outcome measures
included active-assisted knee flexion, active extension, quadriceps lag, manipulation
under anaesthetic, length of stay, quality of life, blood loss, haemoglobin, need for
blood transfusion and pain.
3.4. Materials
The study took place at Hollywood Private Hospital in Nedlands, Western Australia. All
materials required were available in the Physiotherapy Department at Hollywood
Private Hospital. These included a goniometer, CPM machines, pulleys and slings,
slideboards, towel rolls, zimmer frames and elbow crutches.
3.5. Procedures
The total knee arthroplasties were performed by two different surgeons, using
cemented Genesis II prosthesis from Smith and Nephew (Memphis, USA) inserted
using computer navigation (Brainlab, Westchester, USA) with identical surgical
techniques. The surgeons were blinded to the patient’s allocated treatment group.
19
All patients had a single-dose intra-articular 120ml injection of local anaesthetic
(ropivacaine 0.2%) with adrenaline (0.5mg) intra-operatively as their primary mode of
analgesia. They also had a fentanyl PCA (patient controlled analgesia) in the initial
post-operative period.
Patients in Group A had the CPM applied in theatre set to cycle 70-90 degrees and this
was continued for the first 48 hours post-operatively. On post-operative day one the
CPM angle was adjusted to cycle 0-90 degrees. The patients in Group A only had the
CPM removed to ambulate with the physiotherapist on post-operative day one. Both
groups ambulated with a zimmer frame and the physiotherapist twice on post-operative
day one if able and progressed to elbow crutches as able. Both groups were taught
deep breathing and circulation exercises on post-operative day one. Group B
commenced a physiotherapy range of motion and strengthening program on post-
operative day one. This program included active-assisted knee flexion using a pulley
and sling and a slideboard, knee extension exercises using a towel roll under the ankle,
inner range quadriceps exercises over a towel roll and straight leg raise exercises.
Patients performed 10 repetitions of each exercise if able and were encouraged to
perform the exercises three times each day. The physiotherapist supervised these
exercises twice a day and the patients performed the third set of exercises
independently in the evening. The patients in Group B were assessed in each
treatment session starting on post-operative day one for the need for CPM. If the
patient had less than 70 degrees of active-assisted knee flexion they received one hour
of CPM at a range set from 0 degrees to the maximum flexion angle tolerated.
Group A commenced the same physiotherapy exercise program after the removal of
the CPM on post-operative day two. Both groups had the same physiotherapy from
post-operative day two onwards and continued to have one hour per day of CPM if the
active-assisted knee flexion was below 70 degrees. Patients in both groups had two
physiotherapy sessions per day for the first three post-operative days and then one
20
physiotherapy session per day until discharge, including weekends. Patients in both
groups were taught a sitting and standing exercise program when able. The sitting
exercises included active-assisted knee flexion using the unoperated leg to assist and
inner range quadriceps exercises in a chair. The standing exercises included hip/knee
flexion, hamstring curls and a flexion/extension lunge stretch on a small step. Patients
received gait re-education with elbow crutches and were discharged using either one or
two elbow crutches to ambulate. All patients were taught how to negotiate stairs with
elbow crutches prior to discharge. Patients in both groups were told to attend out-
patient physiotherapy sessions post discharge and were given a physiotherapy referral
letter to take to a private practice physiotherapist. One surgeon insisted his patients
attend out-patient physiotherapy three times per week for at least a month post
discharge and the other surgeon allowed the patient and physiotherapist to determine
the frequency of out-patient physiotherapy.
Patients’ active knee flexion, active-assisted knee flexion and active knee extension
range of motion were measured by a Physiotherapist using a goniometer and recorded
pre-operatively, on post-operative day four and three months post-operatively. All
range of motion measurements were taken with the patient in supine. The landmarks
used were the lateral malleolus, lateral femoral condyle and the greater trochanter. The
patient did five repetitions as a practice and then the sixth repetition was measured.
Gogia et al25 demonstrated high inter-rater reliability and validity for measurement of
the knee joint using goniometry. The inter-rater reliability was maximised in this study
by only having two Physiotherapists taking measurements and by assessing their inter-
rater reliability prior to the commencement of the study (Kappa value 0.7, p<0.001).
The inter-rater reliability was assessed by taking measurements of a total of 30
subjects. This included subjects who had a previous TKA and subjects who had no
TKA. Strength of the quadriceps muscles was measured by the patient’s quadriceps
lag which was measured by a Physiotherapist using a goniometer pre-operatively, on
post-operative day four and at three months. The same position and landmarks where
21
used as those used to measure range of motion. The patient had one practice and then
the second repetition was measured. Quadriceps lag is the inability of the quadriceps
muscle to move the knee joint to its passive limit of extension.26
Blood loss via the drain was recorded from the nursing records after removal of the
drain. Pre and post-operative haemoglobin levels were recorded and the number of
units of blood transfused was recorded.
The patient’s level of pain was assessed pre-operatively, on post-operative day 0-4 and
three months post-operatively. The patient was asked to rate their highest level and
average level of pain for each day using a visual numeric rating scale, where 0 was no
pain and 10 was the highest pain possible. The visual numeric rating scale is a patient
self-report scale and is a reliable measure of pain.27 The Physiotherapist assessed the
patient’s level of pain using the Functional Activity Score. The Functional Activity Score
is an observer rated pain scale and is important to compliment the patient’s self-report
(see Appendix D). The need for additional analgesia (eg. commencement of an
epidural) during the first two post-operative days was recorded. The number of patients
requiring a manipulation under anaesthetic of the knee joint by three months post-
operatively was recorded. Quality of Life was measured pre-operatively and at three
months post-operatively using the SF-36 Health Survey Version 1.0 which is a reliable
and valid measure of Quality of Life28 (see Appendix E). Length of stay for all patients
was recorded by the Physiotherapist. All pre-operative measurements were taken
within the 24 hours prior to the surgery. Measurements were recorded on the data
sheet (see Appendix F).
It was impossible to blind the patients as they knew if they were on the CPM machine.
Only two Physiotherapists, both with experience in orthopaedic physiotherapy, were
involved in the treatment of patients to increase reliability. The treating Physiotherapists
22
were unable to be blinded however the two Physiotherapists taking the measurements
were blinded to the treatment groups.
3.6. Ethical Considerations
The Hollywood Private Hospital Research Ethics Committee and the Human Research
Ethics Office of The University of Western Australia granted application for ethical
approval.
3.7. Data Analysis
The clinically significant difference in the primary outcome of knee flexion used was 15
degrees.7 The sample size calculations were done using a G-Power priori power
analyses. A sample size of 18 patients in each group was required to show an effect
size of 0.75, with statistical power of 70% and a significance level of 0.05.
Group differences were compared using unpaired t-tests for continuous data and chi-
square tests for categorical data. Data analysis was performed using the Predictive
Analytics Software (PASW®) Statistics 18 (previously SPSS) program. Statistical
significance was determined by p<0.05. All raw data and data analysis is presented in
Appendix G and Appendix H.
4. Results
4.1. Demographic Data
Demographic data of the two groups is shown in Table 2 and Table 3. There was no
significant difference in age, gender, pre-operative body mass index (BMI) or side of
surgery between the two groups. There were two orthopaedic surgeons and four
anaesthetists with no significant difference between the two groups. Group A had
significantly higher mean pre-operative haemoglobin than Group B (p=0.020) however
23
there was no significant difference between groups pre-operatively for any other
outcome measures. Only two patients in the Group B required CPM due to their active-
assisted knee flexion being less than 70 degrees. All data analysis was performed both
with these two patients excluded and with them included and there was no difference in
the results. The results presented include the two patients in Group B who required
CPM for one hour per day due to their active-assisted knee flexion being less than 70
degrees. No patients in Group A required CPM again after it was ceased on post-
operative day two.
4.2. Active Knee Flexion
There was no significant difference between the two groups for the primary outcome
measure of active knee flexion at any of the measurement intervals (see Table 4 and
Figure 1). Pre-operatively, Group A had a mean active knee flexion of 121.1 degrees
(SD 10.4 degrees) and Group B had a mean active knee flexion of 124.5 degrees (SD
10.4 degrees) (p=0.321). On post-operative day four the mean active knee flexion for
Group A and B was 96.1 degrees (SD 8.7 degrees) and 93.8 degrees (SD 16.5
degrees) respectively (p=0.579). Group A had a mean active knee flexion of 118.3
degrees (SD 10.3 degrees) at three months post-operatively and Group B of 120.0
degrees (SD 12.9 degrees), there was no significant difference between groups
(p=0.664).
4.3. Active-Assisted Knee Flexion
No significant difference was demonstrated between the two groups for active-assisted
knee flexion at any of the measurement intervals (see Table 4). Pre-operatively, the
mean active-assisted knee flexion for Group A and B was 123.6 degrees (SD 9.8
degrees) and 126.0 degrees (SD 9.0 degrees) respectively (p=0.438). Group A had a
mean active-assisted knee flexion of 100.8 degrees (SD 7.7 degrees) on post-
operative day four and Group B of 98.0 degrees (SD 14.6 degrees), there was no
significant difference between groups (p=0.455). At three months post-operatively,
24
Group A had a mean active-assisted knee flexion of 119.4 degrees (SD 10.1 degrees)
and Group B had a mean active-assisted knee flexion of 120.8 degrees (SD 12.6
degrees) (p=0.729).
4.4. Active Knee Extension
Active knee extension showed no significant difference between the two groups pre-
operatively or at three months post-operatively however Group B had significantly more
knee extension then Group A on post-operative day four (see Table 4 and Figure 2).
Group A had a mean active knee extension of -3.1 degrees (SD 4.2 degrees) pre-
operatively and Group B -6.0 degrees (SD 5.0 degrees), there was no significant
difference between groups (p=0.060). On post-operative day four, Group A had a mean
active knee extension of -7.8 degrees (SD 4.3 degrees) and Group B had significantly
more active knee extension with a mean of -4.8 degrees (SD 4.7 degrees) (p=0.046).
Three months post-operatively, the mean active knee extension for Group A and B was
-3.6 degrees (SD 2.9 degrees) and -3.5 degrees (SD 4.0 degrees) respectively
(p=0.922).
4.5. Quadriceps Lag
There was no significant difference between the two groups for at any of the
measurement intervals for quadriceps lag (see Table 4). Pre-operatively, Group A had
a mean quadriceps lag of 2.2 degrees (SD 3.1 degrees) and Group B had a mean
quadriceps lag of 2.0 degrees (SD 3.0 degrees) (p=0.823). Four days post-operatively,
the mean quadriceps lag for Group A and B was 13.3 degrees (SD 9.1 degrees) and
12.5 degrees (SD 11.5 degrees) respectively (p=0.807). Group A had a mean
quadriceps lag of 5.0 degrees (SD 4.2 degrees) three months post-operatively and
Group B 5.3 degrees (SD 3.4 degrees), there was no significant difference between
groups (p=0.841).
25
4.6. Manipulation Under Anaesthetic
One patient in Group B and no patients in Group A required a manipulation under
anaesthetic in the first three months post-operatively. There was no significant
difference between groups for the number of manipulations under anaesthetic required
(p=0.336).
4.7. Length of Stay
There was no significance difference between groups for the length of stay (p=0.983).
Patients in Group A had a mean length of stay of 6.7 days (SD 2.1) and those in Group
B had a mean length of stay of 6.7 days (SD 2.7) (see Table 5).
4.8. Quality of Life
Quality of Life was measured using the SF-36. The mean physical component
summary and mean mental component summary were compared between groups (see
Table 5). There was no significant difference between groups for the physical or mental
component summary pre-operatively or at three months post-operatively. Pre-
operatively, the mean physical component summary for Group A was 37.2 (SD 8.3)
and Group B was 34.7 (SD 8.5) (p=0.361). At three months post-operatively the mean
physical component summaries were 44.0 (SD 7.4) and 45.8 (SD 7.2) for Group A and
B respectively (p=0.467). The mean mental component summary for Group A and B
pre-operatively were 59.0 (SD 6.6) and 56.0 (SD 11.2) respectively with no significant
difference between groups (p=0.329). At three months post-operatively the mean
mental component summary for Group A was 58.1 (SD 7.3) and Group B was 56.9 (SD
7.6) (p=0.631).
When data for all patients was analysed, patients showed no significant difference in
the mental component summary from pre-operatively (mean 57.4, SD 9.5) compared to
three months post-operatively (mean 57.5, SD 7.5) (p=0.948). However, there was a
26
significant improvement in the physical component summary for all patients at three
months post-operatively (mean 45.0, SD 7.3) when compared to pre-operatively (mean
36.0, SD8.4) (p<0.001).
4.9. Haemoglobin, Blood Loss and Blood Transfusion
The mean pre-operative Haemoglobin was significantly higher (p=0.020) in Group A
than Group B. Group A had a mean pre-operative Haemoglobin of 138.6 g/L and
Group B had a mean of 127.5 g/L. Post-operatively Group A and B had mean
Haemoglobins of 113.5 g/L and 104.0 g/L, respectively, this was also significantly
different (p=0.014) (see Table 5 and Figure 3). Despite the significant difference in
Haemoglobin there was no significant difference in the number of patients who required
a blood transfusion post-operatively (p=0.162). Five patients in Group A required a
blood transfusion and ten patients in Group B. Group A had a mean blood loss in the
drain of 1018.6 ml (SD 342.6 ml) which was significantly (p=0.009) more than Group B
which had a mean blood loss of 709.0 ml (SD 342.9 ml) (Table 5 and Figure 4).
4.10. Pain
Seven patients in Group A required an intervention on the ward due to high pain levels
which was significantly higher (p=0.036) than the two patients in Group B who required
an intervention on the ward due to high pain (see Table 6 and Figure 5). Of the seven
patients in Group A, five required an epidural to be commenced on the ward and two
required the CPM machine to be removed due to pain. In Group B, one patient required
an epidural to be commenced on the ward and one patient required both an epidural
and femoral nerve block on the ward due to pain (see Figure 6).
There was no significant difference between the two Groups for the Functional Activity
Score pre-operatively, Day 0-4 or three months post-operatively (see Table 7). There
was also no significant difference in mean or maximum Visual Numeric Rating Scale
27
score between Group A and B pre-op, pre-operatively, Day 0-3 or three months post-
operatively (see Table 8).
All patients who required an epidural to be commenced on the ward had a bupivacaine
(0.125%) epidural or a bupivacaine (0.125%) plus fentanyl (5mg/ml) epidural. There
was no significant difference between the two combinations between groups (see
Table 9).
All patients received regular paracetamol and also received oxycodone and/or
tramadol. There was no significant difference between Group A and B for type of drug
or the doses of any of these drugs (see Table 10 and Table 11). Thirty-two patients
received either diclofenac, celecoxib, meloxicam or parecoxib. There was no significant
difference between the two groups for the type of anti-inflammatory or the dose given
(see Table 12). All patients had a fentanyl PCA and the dose used was not significantly
different between groups (see Table 11).
4.11. Complications
No patients experienced post-operative complications which prevented physiotherapy
in the first four post-operative days. One patient in each group had atrial fibrillation (AF)
post-operatively. One patient in Group A had wound ooze on post-operative day six
which required them to rest in bed for the day and another patient in Group A had a
deep vein thrombosis (DVT) post-operatively. One patient to Group B developed fluid
overload post-operatively. There was no significant difference between the two groups
for post-operative complications.
28
5. Discussion
Our results support those of Alkire and Swank13, Beaupre et al14, Bruun-Olsen et al15
and Bennett et al2 who all found no significant difference in knee flexion at three
months post-operatively. These studies compared CPM for two hours three times
daily13,14,15 or three hours twice daily2 to no CPM. Pope et al7 compared two CPM
regimens of continuous CPM for 48 hours to a third group with no CPM. One CPM
group had CPM 0-40 degrees while the other had CPM 0-70 degrees.7 Pope et al7
found the group who had continuous CPM 0-70 degrees had significantly more knee
flexion than the group who had no CPM after one week. However, at one year post-
operatively they found no significant difference in flexion or extension between the
three groups.7
A systematic review of the literature comparing CPM to a rehabilitation program that
allows early knee mobilisation concluded that CPM was more likely to have an effect
on outcomes if it was applied immediately post-operatively, for a significant amount of
time each day and was at a high flexion angle.3 Our study achieved all of these
suggestions by applying the CPM in theatre at a high flexion angle and continuing the
CPM for 48 hours but found no significant difference in active knee flexion between
groups on post-operative day four or three months post-operatively.
We found a significant increase in blood loss via the drain in the 48 hour CPM group
which is consistent with the findings of Pope et al7. Pope et al7 found no significant
difference in blood loss between a group who had no CPM and a group who had CPM
started at 0-40 degrees. However, they found a group who had CPM started at 0-70
degrees had significantly more blood loss than the 0-40 degree group and the no CPM
group.7 While Alkire and Swank13 reported less blood loss in patients who had no CPM
compared to CPM this did not reach significance. Alkire and Swank13 started the CPM
at 70-90 degrees in recovery which was the same as our study however they applied
CPM for two hours, three times per day rather than continuously. Harms and
29
Engstrom4 also found no significant difference in blood loss when comparing patients
receiving no CPM to those having CPM 0-40 degrees, increased by 10 degrees per
day. Like Alkire and Swank13, Harms and Engstrom4 applied the CPM for a total of six
hours per day. This difference in results compared to this study is likely to be related to
the duration of CPM. Our results along with the results of Alkire and Swank13, Harms
and Engstrom4 and Pope et al7 suggest there is increased blood loss via the drain
when CPM is used continuously at a high flexion angle but not when it is used for
shorter durations or at a lower flexion angle. An increase in blood loss can increase the
chance of needing a transfusion and is therefore a disadvantage of CPM.
There was no significant difference in the number of patients requiring a blood
transfusion however this may have been due to the significantly higher haemoglobin in
the 48 hour CPM group pre-operatively. The 48 hour CPM group also had significantly
higher post-operative haemoglobin than the other group. Greater blood loss increases
the chance of a patient needing a blood transfusion so it is possible that if the groups
were comparable for pre-operative haemoglobin that there may have been more
patients in the 48 hour CPM group requiring a blood transfusion due to the significantly
higher blood loss in this group. A limitation of this study is the significantly higher
haemoglobin in the 48 hour CPM group pre-operatively. This makes it difficult to make
any conclusions about the number of patients in each group who required a blood
transfusion post-operatively.
Several studies have found no significant difference in pain with CPM post TKA4,15,18
however these studies used CPM for a maximum of six hours per day. We support the
findings of Pope et al7 who compared continuous CPM to no CPM and found the CPM
groups required significantly more analgesia. They found the group who had CPM
started at 0-40 degrees required significantly more analgesia than the no CPM group
and the 0-70 degree CPM group also required significantly more analgesia than the no
CPM group.7 Pope et al7 found no significant difference in analgesia requirement
30
between the two CPM groups. Their results suggest continuous CPM at low or high
flexion angles causes more pain than no CPM. While this study showed no significant
difference between groups in amount of oral analgesia or PCA doses required this is
likely to be due to the interventions on the ward to reduce pain levels. There were
significantly more interventions on the ward required in the continuous CPM group than
the other group. Five patients in this group required an epidural to be commenced on
the ward due to pain and two patients required the CPM machine to be removed due to
pain. While patient comfort is a priority after TKA these extra interventions on the ward
due to pain require additional staffing hours and therefore increase the cost of post-
operative care. For this reason continuous CPM has a negative impact on both patient
comfort and cost of post-operative care.
We found no significant difference between groups for the need for a manipulation
under anaesthetic or the length of stay which supports the findings of Alkire and
Swank13. Beaupre et al14 reported no significant difference in Quality of Life measured
using the SF-36 which is supported by our results.
While we found the continuous CPM group had significantly less knee extension at four
days post-operatively there was no significant difference in knee extension between
groups at three months post-operatively. This reduced knee extension on post-
operative day four may be due to the first 24 hours when the continuous CPM group
had the CPM cycling from 70-90 degrees. Our results support those of Bennett et al2 in
that we found no significant difference in quadriceps lag or knee extension at three
months post-operatively.
There are several weaknesses to this study. Along with the significant difference in pre-
operative haemoglobin already discussed another weakness of this study is the small
sample size. However, the results of this study have indicated similar findings to
previous studies which have had larger samples sizes. One of the major weaknesses is
31
the loss of nine patients at the three month follow-up. However these patients were
distributed evenly between the two treatment groups with four in Group A and five in
Group B. A further weakness is the difference in physiotherapy post discharge. As our
facility does not offer out-patient physiotherapy we were unable to standardise the
physiotherapy received between discharge and three months post-operatively. One
surgeon insisted his patients attend out-patient physiotherapy three times a week for at
least a month post discharge and recommended a particular practice. The other
surgeon allowed the patient to attend physiotherapy at a practice of their choice closer
to their house and did not specify a frequency of treatment sessions. Despite this
potential difference in post discharge physiotherapy there was no significant difference
in the number of patients each surgeon had in each treatment group so this should not
have had an effect on the results.
6. Conclusion
We found no benefit of using CPM for 48 hours continuously on patients who have
received an intra-articular injection for analgesia post total knee arthoplasty. These
patients had less knee extension on post-operative day four, experienced more pain
and had greater blood loss post-operatively than patients who had either no CPM or
CPM for one hour per day. These clinical disadvantages of continuous CPM are not
justified as there were no improvements in range of motion, strength, length of stay or
quality of life as a result of continuous CPM. As a result of this study the clinical
practise at our facility has changed. Patients no longer have CPM for 48 hours
continuously after a TKA.
32
7. Tables Table 1: Summary of CPM Journal Articles Author/ Year
Sample Population Mean Age(yrs)
Treatment Follow-up
Results Conclusion
Alkire 2010
Randomised 65 A: 33 B: 32
Computer-navigated TKA, OA, RA, >18yrs Exclusion: cognitive/ sensory deficits, nursing home patients, non-English speaking
A: 65.6 B: 66.9
A: PT + CPM B: PT CPM Parameters:
2hrs 3x/dy
Start in recovery for 3days (D0-D2)
70-90o, increasing ext over first 4hrs
PT Parameters:
2x/dy
3 mths Range of Motion- pre-op, 2wk, 6wk, 3mth - no significant difference
Oedema - no significant difference
Drainage-slightly less in No CPM group,no sig dif
Hematocrit - no significant difference
Blood Transfusion - no pts required blood
Pain + function (WOMAC) - no significant diff
MUA - no significant difference
LOS - no significant difference
No sig difference in flexion, oedema or drainage, function. No benefit of in-hospital CPM
Beaupre 2001
Randomised 120 A:40 B:40 C:40
Primary TKA A: 68 B: 68 C: 69
A: PT + CPM B: PT + slider board C: PT CPM Parameters:
2hrs 3x/dy
Start D2
0-30o, increased as tolerated
Slider Board Parameters:
2x 10min /dy
Start D2 PT Parameters:
30mins
SOEOB D1, amb D2
exercises commenced D3 for all groups – amb, ROM, IRQ, SLR
6 mths ROM- pre-op, D5-7, 3mth, 6mth - no significant difference in flex or ext
QOL-WOMAC + SF36 - no significant difference
No difference in ROM or QOL Addition of either CPM or slider board to PT is not warranted
Bennett 2005
Randomised 147 A: 47 B: 48 C: 52
OA, primary TKA. Exclusion – haemophilia, RA
A: 70.7 B: 71.4 C: 71.7
A: PT + CPM 0-40, increase by 10 per day + R/S overnight B: PT + CPM 50-90, increase extension by 10 per session – knee rested at 90 on CPM when not cycling for first 3 days and nights, then R/S overnight starting D3 C: PT only – R/S overnight CPM Parameters:
Start in recovery
3hrs BD for 6 days PT Parameters:
Start D1
30mins BD
A/A flex, ext, IRQ, SLR exercises
1 year Flexion – pre-op, D5, 3mths, 1 year - Significantly higher flexion in CPM 50-90 group at D5, No significant difference in flexion at other time
Extension - no significant difference
Quads lag - no significant difference
LOS - no significant difference
Wound healing - no significant difference
Knee function - no significant difference
QOL- SF-12 - no significant difference
Early flexion CPM regime improves flexion in short-term but no difference in outcomes long-term
33
Author/ Year
Sample Population Mean Age(yrs)
Treatment Follow-up
Results Conclusion
Bruun-Olsen 2009
Randomised 63 A: 30 B: 33
Primary TKA, OA, good cognitive function, fluent Norweign Exclusion – RA, previous ipsilateral THR
A: 68 B: 71
A: PT + CPM B: PT CPM Parameters:
Start D0 70-100o 2hrs BD
D1 0-100o 2hrs TDS
1 week PT Parameters:
30mins/dy
Start D1
A/A + AROM flex + ext, SQ, ambulation
3 mths ROM – pre-op, 1wk, 3mths- no significant difference
Pain – VAS- no significant difference
Ambulation – TUG, 40m walk, stairs- no significant difference
Swelling - circumference- no significant difference
CPM no additional short-term benefit on pain, ROM or walking ability when compared to active physio only
Chen 2000
Randomized 51 A: 23 B: 28
Primary TKA Exclusion: bilat TKR, intolerance of CPM, sig drainage, infection, Rev TKR, >240lbs
Male: 72 Female: 65
A: PT + CPM B: PT CPM Parameters:
Started within 24hrs
initially 0-passive knee flex -10o,
increased daily as tolerated
5hrs/dy until D/C (approx 8dys) PT Parameters:
2hrs/dy
1 wk Active + Passive ROM – pre-op, D3, D7, D/C - No significant difference in knee flex or ext
Swelling – circumference - no significant difference
Use of CPM no additional benefit with respect to ROM or swelling
Denis 2006
Randomised 81 A: 26 B: 28 C: 27
Primary TKA, OA Exclusion: medical conditions that interfere with test performance, comprehension problems, neuromuscular or neurodegenerative disease, concurrent intervention during surgery, infection, major complications
A: 69.6 B: 68.4 C: 67.1
A: PT + CPM 35mins daily B: PT + CPM 2hrs daily C: PT only CPM Parameters:
Start D2
0-35/45o
increased daily as tolerated until discharge
PT Parameters:
D1: DB + circulation, SQ, extension splint insitu
D2:splint removed, active + passive knee flex, hip abd/add, IRQ
D4: WB exercises
D/C (D7-8)
ROM – pre-op + D/C – no significant difference
Functional ability – WOMAC + TUG - no significant difference
LOS-theoretical and real - no significant difference
Adding CPM to convention physio has no short-term effect on ROM, functional ability or LOS
34
Author/ Year
Sample Population Mean Age(yrs)
Treatment Follow-up
Results Conclusion
Harms 1991
Randomised 113 A: 55 B: 58
OA, RA, Primary TKR, knee flex contracture <40, walk 10m within 2 min with aid, able to sit to stand, 40-90yrs Excluded: Rev TKR, concurrent knee Sx, condition compromising treatment
A: 69 B: 71
A: CPM B: PT only CPM Parameters:
Start in recovery
6hrs/dy until 80o of flex
0-40 1st 48hrs, increased 10
o/dy
immobilised in splint or backslab when off CPM
PT Parameters:
2x/dy, min 10min/session
Day1: splint, SQ, SLR, SG, ankle ex
Day 2: mobilise in splint
Day 3: AKF, IRQ, splint removed
Day 5: mobilise without splint if SLR
D/C(D17-18)
ROM
Significantly more flexion in CPM group than no-CPM group at D7, D14 and D/C
Significantly more extension in CPM group than no-CPM group at D7, D14 and D/C
Pain - No significant difference
Wound drainage – no significant difference
‘Ease Score’ – significantly ‘easier’ to regain ROM in CPM group
Complications - no significant difference
LOS - no significant difference
Referral to out-pt physio - no significant difference
Regime incorporating CPM will produce an overall improvement in the speed and quality of recovery in TKR patients
Leach 2006
Randomised 55 A: 38 B: 44
OA Excluded - RA
A: 71.2 B: 72.9
A: PT + CPM B: PT CPM Parameters:
Start D1
1hr BD
0-30o, increased by 10
o/dy
PT Parameters:
D1: slide board ex + quads ex
D3: 90o encouraged + ECs
1 year ROM – pre-op, discharge (D5-7), 6wks, 6mth, 12mth - no significant difference
Pain – VAS + analgesia use - no significant difference
Short duration CPM does not influence outcome of pain or ROM
Lenssen 2008
Randomised 60 A: 30 B: 30
Primary TKA, OA, less than 80
o flexion on
D4, fluent Dutch, no mental disabilities Excluded – RA, LOS greater than 5dys, co-morbidity influencing mobility, minimally invasive surgery, older than 80yrs of age
A: 64.1 B: 65.0
A: CPM + PT first 17dys B: CPM + PT first 4dys then first 2weeks post discharge PT only CPM Parameters:
Start in recovery
2hrs BD as tolerated PT Parameters:
20mins/dy
ROM and strengthening exercises
3 mths ROM – pre-op, D/C, D17, 6wks, 3mths – no significant difference in flexion at 6wks or 3 mths
Function – KSS + WOMAC – no significant difference
Perceived effort– no significant difference
Post-op medication – no significant difference
Satisfaction with treatment – no significant difference
Satisfaction with treatment result – no significant difference
Adherence to treatment – no significant difference
Quantity and duration of PT – no significant difference
Small short term benefit of CPM No long term benefit of CPM
35
Author/ Year
Sample Population Mean Age(yrs)
Treatment Follow-up
Results Conclusion
Pope 1997
Randomised 53 (57 knees) A: 17 (18 knees) B: 18 (20 knees) C: 18 (19 knees)
Primary TKA, OA or RA Excluded: fixed deformity >30
o
A: 72.5 B: 72.7 C: 69.6
A: CPM 0-40 B: CPM 0-70 C: extension splint in recovery, removed only for PT, removed D3 CPM Parameters:
Start in recovery
Minimum 20hrs/dy for first 2dys
increased 10o/dy
PT Parameters:
2x/dy, 10 reps each ex
D3: SQ + SG, IRQ, SLR, AROM, gait re-ed
1 year ROM – pre-op, 1wk, 1yr
1wk significantly more flex in CPM 0-70 group compared to no CPM
1 yr – no significant difference
Functional ability – no significant difference
Blood loss - Significantly more blood drainage in CPM groups compared to no CPM
Analgesia - CPM resulted in a significantly more analgesia than No CPM
Show clinical disadvantages of CPM in the short-term with no improvement of ROM or function
36
Table 2. Demographics
Group A
n=18
Group B
n=20
n(%) n(%) p
Male 11(61) 7(35) 0.107
Right knee 8(44) 13(65) 0.203
Surgeon A 15(83) 17(85) 0.888
Table 3. Age and Pre-operative BMI
Group A
n=18
Group B
n=20
p
Mean Diff (95% CI) Mean(SD) Mean(SD)
Age, years 67.9(6.1) 66.7(9.8) 0.652 1.19(-4.13-6.51)
BMI 28.8(4.0) 26.8(3.0) 0.092 1.98(-0.34-4.29)
Table 4. Knee ROM and Quadriceps Lag
Group A
n=18
Group B
n=20
Mean(SD) Mean(SD) p Mean Diff (95% CI)
Active
Flexion, o
Pre-op 121.1(10.4) 124.5(10.4) 0.321 -3.39(-10.22-3.44)
Day 4 Post-op 96.1(8.7) 93.8(16.5) 0.579 2.36(-6.24-10.96)
3mths Post-op 118.3(10.3) 120.0(12.9) 0.664 -1.67(-9.39-6.06)
Active-
Assisted
Flexion , o
Pre-op 123.6(9.8) 126.0(9.0) 0.438 -2.39(-8.57-3.79)
Day 4 Post-op 100.8(7.7) 98.0(14.6) 0.455 2.83(-4.82-10.49)
3mths Post-op 119.4(10.1) 120.8(12.6) 0.729 -1.31(-8.88-6.27)
Active
Extension,
o
Pre-op -3.1(4.2) -6.0(5.0) 0.060 -2.94(-6.02-0.14)
Day 4 Post-op -7.8(4.3) -4.8(4.7) 0.046 3.03(0.05-6.00)
3mths Post-op -3.6(2.9) -3.5(4.0) 0.922 0.11(-2.17-2.39)
Quads
Lag, o
Pre-op 2.2(3.1) 2.0(3.0) 0.823 0.22(-1.78-2.22)
Day 4 Post-op 13.3(9.1) 12.5(11.5) 0.807 0.83(-6.05-7.71)
3mths Post-op 5.0(4.2) 5.3(3.4) 0.841 -0.25(-2.76-2.26)
37
Table 5. LOS, QOL, Haemoglobin and Blood Loss
Group A
n=18
Group B
n=20
Mean(SD) Mean(SD) p Mean Diff (95% CI)
LOS, d 6.7(2.1) 6.7(2.7) 0.983 0.02(-1.58-1.61)
SF 36 Physical
Component
Summary
Pre-op
37.2(8.3) 34.7(8.5) 0.361 2.56(-3.05-8.18)
3mths
Post-op
44.0(7.4) 45.8(7.2) 0.467 -1.77(-6.64-3.11)
SF 36 Mental
Component
Summary
Pre-op 59.0(6.6) 56.0(11.2) 0.329 3.07(-3.23-9.36)
3mths
Post-op
58.1(7.3) 56.9(7.6) 0.631 1.20(-3.8-6.21)
Haemoglobin,
g/L
Pre-op 138.6(13.3) 127.5(14.6) 0.020 11.06(1.82-20.29)
Day 1
Post-op
113.5(8.9) 104.0(13.1) 0.014 9.5(2.03-16.97)
Blood Loss,
mls
1018.6(342.6) 709.0(342.9) 0.009 309.61(83.68-535.55)
Table 6. MUA, Blood Transfusion and Intervention due to Pain
Group A
n=18
Group B
n=20
n(%) n(%) p
MUA 0(0) 1(5) 0.336
Blood Transfusion
Required
5(28) 10(50) 0.162
Intervention Required
on Ward due to Pain
7(39) 2(10) 0.036
Table 7. Functional Activity Score (FAS)
Group A
n=18
Group B
n=20
FAS A
n(%)
B
n(%)
C
n(%)
A
n(%)
B
n(%)
C
n(%)
p
Pre-op 16(89) 2(11) 0(0) 15(75) 5(25) 0(0) 0.270
Day 0 post-op 0(0) 14(78) 4(22) 0(0) 17(85) 3(15) 0.566
Day 1 Post-op 0(0) 16(89) 2(11) 0(0) 17(85) 3(15) 0.723
Day 2 Post-op 0(0) 16(89) 2(11) 0(0) 20(100) 0(0) 0.126
Day 3 Post-op 0(0) 18(100) 0(0) 0(0) 20(100) 0(0)
Day 4 Post-op 0(0) 17(94) 0(0) 1(5) 19(95) 0(0) 0.350
3mths Post-op 17(94) 1(6) 0(0) 20(100) 0(0) 0(0) 0.285
38
Table 8. Visual Numeric Rating Scale
Group A
n=18
Group B
n=20
Mean
(SD)
Mean
(SD)
p Mean Diff (95% CI)
Visual
Numeric
Rating
Scale
Average
Pre-op, n 2.9(2.2) 3.5(1.9) 0.388 -0.58(-1.94-0.77)
Day 0 post-op, n 4.4(2.4) 5.1(2.2) 0.402 -0.63(-2.15-0.88)
Day 1 Post-op, n 3.0(1.9) 4.3(2.3) 0.075 -1.27(-2.68-0.14)
Day 2 Post-op, n 2.6(1.3) 3.6(2.1) 0.093 -0.99(-2.16-0.17)
Day 3 Post-op, n 2.0(1.6) 2.1(2.1) 0.938 -0.47(-1.27-1.17)
3mths Post-op, n 1.1(1.2) 1.0(1.5) 0.814 0.11(-0.80-1.01)
Visual
Numeric
Rating
Scale
Maximum
Pre-op, n 6.5(2.4) 6.2(2.0) 0.606 0.38(-1.09-1.85)
Day 0 post-op, n 7.0(3.0) 8.0(2.4) 0.261 -1.00(-2.78-0.78)
Day 1 Post-op, n 7.1(2.8) 7.9(1.8) 0.258 -0.89(-2.48-0.69)
Day 2 Post-op, n 6.3(2.3) 7.5(2.1) 0.100 -1.22(-2.69-0.24)
Day 3 Post-op, n 5.3(2.3) 6.5(1.7) 0.066 -1.24(-2.57-0.08)
3mths Post-op, n 3.6(2.6) 3.1(1.9) 0.452 0.51(-0.85-1.87)
Table 9. Epidural Drug
Group A
n=18
Group B
n=20
n(%) n(%) p
Bupivacaine (0.125%) 2(11) 0(0) 0.290
Bupivacaine (0.125%) + Fentanyl (5mg/ml) 3(17) 2(10)
Table 10. Number of Patients who had Oral Analgesia
Group A
n=18
Group B
n=20
n(%) n(%) p
Paracetamol 18(100) 20(100)
Oxycodone IR 17(94) 19(95) 0.939
Oxycodone SR 2(11) 5(25) 0.270
Tramadol 5(28) 2(10) 0.158
Table 11. Dose of Fentanyl and Oxycodone IR
Group A
n=18
Group B
n=20
Mean(SD) Mean(SD) p
Total Fentanyl dose via PCA, mls 194.0(110.5) 196.2(90.0) 0.947
Total Oxycodone IR dose, mg 76.8(41.9) 73.7(66.5) 0.868
39
Table 12. Number of Patients who had Anti-Inflammatories
Group A
n=18
Group B
n=20
n(%) n(%) p
Diclofenac 2(11) 6(30) 0.154
Meloxicam 1(6) 0(0) 0.285
Celecoxib 10(56) 12(60) 0.782
Parecoxib 0(0) 1(5) 0.336
40
8. Figures
0
20
40
60
80
100
120
140
160
Pre-op Day 4 Post-op 3mths Post-op
Error Bars: SD
Mean (
degre
es)
Group A
Group B
Figure 1. Mean Active Knee Flexion
Figure 2. Mean Knee Extension
41
0
20
40
60
80
100
120
140
160
Pre-Op Hb Post-Op Hb
*p=0.020 *p=0.014 Error Bars: SD
Mean (
g/L
)
Group A
Group B
Figure 3. Mean Haemoglobin
0
200
400
600
800
1000
1200
1400
1600
Group A Group B
*p=0.009 Error Bars: SD
Mean (
mls
)
Figure 4. Mean Blood Loss in Drains
42
0
1
2
3
4
5
6
7
8
Intervention Required on Ward due to Pain
*p=0.036
Num
ber
of P
atie
nts
Group A
Group B
Figure 5. Number of Interventions on Ward Due to Pain
0
1
2
3
4
5
6
Epidural Commenced CPM Ceased Epidural and FNB Commenced
Intervention on Ward Due to Pain
Num
ber
of P
atie
nts
Group A
Group B
Figure 6. Type of Intervention on Ward Due to Pain
43
9. References
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Efficacy of continuous passive motion following total knee arthroplasty: a
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3. Grella R. Continuous passive motion following total knee arthroplasty: a useful
adjunct to early mobilisation? Physical Therapy Reviews. 2008;13:269-79.
4. Harms M, Engstrom B. Continuous passive motion as an adjunct to treatment
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5. Lenssen A, Koke A, De Bie R, Geesink R. Continuous passive motion
following primary total knee arthroplasty: short and long term effects on range of
motion. Physical Therapy. 2003;8:113-21.
6. Lenssen T, Van Steyn M, Crijns Y, Waltje E, Roox G, Geesink R, et al.
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adjunct to physiotherapy, after total knee arthroplasty. BMC Musculoskeletal
Disorders. 2008;9:60.
7. Pope R, Corcoran S, McCaul K, Howie D. Continuous passive motion after
primary knee arthroplasty. Journal of Bone and Joint Surgery (Br).
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8. Viswanathan P, Kidd M. Effect of continuous passive motion following total
knee arthroplasty on knee range of motion and function: A systematic review.
New Zealand Journal of Physiotherapy. 2010;38:14-22.
9. Thorsell M, Holst P, Hyldahl H, Weidenhielm L. Pain control after total knee
arthroplasty: A prospective study comparing local infiltration anaesthesia and
epidural anaesthesia. Orthopedics. 2010;33:75-80.
10. Horlocker TT. Pain management in total joint arthroplasty: a historical review.
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11. Toftdahl K, Nikolajsen L, Haraldsted V, Madsen F, Tonnesen E, Soballe K.
Comparison of peri- and intraarticular analgesia with femoral nerve block after
total knee arthroplasty: a randomised clinical trial. Acta Orthopaedica.
2007;78:172-9.
12. Fajardo M, Collins J, Landa J, Adler E, Meere P, DiCesare PE. Effect of a
perioperative intra-articular injection on pain control and early range of motion
following bilateral TKA. Orthopaedics. 2011;34:e33-6.
13. Alkire M, Swank M. Use of Inpatient Continuous Passive Motion Versus No
CPM in Computer-Assisted Total Knee Arthroplasty. Orthopaedic Nursing.
2010;29:36-40.
14. Beaupre L, Davis D, Jones C, Cinats J. Exercise combined with continuous
passive motion or slider board therapy compared with exercise only: a
randomised controlled trial of patients following total knee arthroplasty. Physical
Therapy. 2001;81:1029-37.
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15. Bruun-Olsen V, Heiberg K, Mengshoel A. Continuous passive motion as an
adjunct to active exercises in early rehabilitation following total knee
arthroplasty – a randomized controlled trial. Disability and Rehabilitation.
2009;31:277-83.
16. Chen B, Zimmerman J, Soul L, DeLisa J. Continuous passive motion after
total knee arthroplasty: A prospective study. American Journal of Physical
Medicine and Rehabilitation. 2000;79:421-6.
17. Denis M, Moffet H, Caron F, Ouellet D, Paquet J, Nolet L. Effectiveness of
continuous passive motion and conventional physical therapy after total knee
arthroplasty: A randomised clinical trial. Physical Therapy. 2006;86:174-85.
18. Leach W, Reid J, Murphy F. Continuous passive motion following total knee
replacement: a prospective randomized trial with follow-up to 1 year. Knee
Surgery, Sports Traumatology, Arthroscopy. 2006;14:922-6.
19. Fowler S, Symons J, Sabato S, Myles P. Epidural analgesia compared with
peripheral nerve blockade after major knee surgery: a systematic review and
meta-analysis of randomized trials. British Journal of Anaesthesia.
2008;100:154-64.
20. Zaric D, Boysen K, Christiansen C, Christiansen J, Stephensen S,
Christensen B. A comparison of epidural analgesia with combined continuous
femoral-sciatic nerve blocks after total knee replacement. Anesthesia and
Analgesia 2006;102:1240-6.
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21. Edwards J, Pandit H, Popat M. Perioperative analgesia: a factor in the
development of heel pressure ulcers? . British Journal of Nursing. 2006;15:S20-
2.
22. Corbett K, Reichmann W, Katz J, Beagan C, Corsello P, Ghazinouri R, et
al. One-day vs two-day epidural analgesia for total knee arthroplasty (TKR): A
retrospective cohort study. The Open Orthopaedics Journal. 2010;4:31-8.
23. Andersen KV, Bak M, Christensen BV, Harazuk J, Pedersen NA, Soballe K.
A randomised, controlled trial comparing local infiltration analgesia with epidural
infusion for total knee arthroplasty. Acta Orthopaedica. 2010;81:606-10.
24. Ong JCA, Lin CP, Fook-Chong SMC, Tang A, Ying YK, Keng TB.
Continuous infiltration of local anaesthetic following total knee arthroplasty.
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measurements at the knee. Physical Therapy. 1987;67:192-5.
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47
Appendix A
PATIENT INFORMATION SHEET To participate in a Medical Research Study
Title of Study: Comparison of Two Continuous Passive Motion Regimens
following Total Knee Arthroplasty Study Sponsor: Hollywood Private Hospital Research Foundation Chief Investigator: Bree Evans INTRODUCTION The following information describes a clinical research study and your role in it should you decide to participate. Please read this carefully and do not hesitate to ask any questions now or anytime during the study. Your participation in this study is entirely voluntary. Your orthopaedic surgeon, Professor David Wood / Mr Greg Janes, supports this study. If you decide to participate in the study you will receive a signed copy of this Patient Information Sheet and Consent Form for your records. NATURE AND PURPOSE OF THIS STUDY The study will compare the effect of using a continuous passive motion (CPM) machine after your knee replacement. The CPM machine bends and straightens your knee slowly while you are lying on the bed. The purpose of this study is to compare the difference in knee movement, strength and pain between patients who have continuous CPM and those who have less or no CPM. EXPECTED STUDY DURATION AND NUMBER OF PARTICIPANTS You will be involved in the study while you are in hospital after your knee replacement. You will also be required to come back to the hospital 3 months after your surgery to have your progress assessed, this will only take about 10 minutes. There is expected to be about 40 participants and the study will take about a year to complete. STUDY PROCEDURES If you agree to participate in the study you will be randomly put in one of two groups (Group A and Group B). If you are in Group A you will be using the CPM machine for the first 2 days after your knee replacement. The machine will be taken off while you stand out of bed with the physiotherapist one day after your surgery but will otherwise be on all the time. If you are in Group B you will only use the CPM machine if you are unable to bend your leg enough by yourself. If this is the case the CPM machine will be put on for one hour each day. You will also stand out of bed with the physiotherapist one day after your surgery and you will be taught an exercise program to start improving the movement and strength in your knee.
48
From the second day after your surgery onwards both groups will receive the same physiotherapy. Your physiotherapist will assess your knee movement and strength and also asking you about your level of pain. Before the study you will be asked to complete a questionnaire about your quality of life, you will then be asked to complete this again three months after your surgery. RISKS AND DISCOMFORTS It is normal to experience pain after a knee replacement and your nurse will be able to give you medication to help with the pain. Please inform your nurse or physiotherapist if you do not feel your pain is well controlled If you are in Group B and your leg is not bending enough by itself, you will still use the CPM machine so you are not at risk of having less bend in your knee. POTENTIAL BENEFITS Your participation will benefit future patients who are having knee replacement. We will be able to decide if it is more beneficial to have continuous CPM after a knee replacement or not. MEDICAL CARE/COMPENSATION Your rights at Australian law do not change upon signing the consent form for this study Should any complications arise in relation to this study you will receive the appropriate medical treatment. WITHDRAWAL FROM STUDY If at any time you wish to withdraw from this study, you are free to do so without prejudice or affecting your current or future medical care. CONFIDENTIALITY A code number will be assigned to your data so that your name will not be attached to it. Your individual data will not be seen by anyone other than the Investigators. INVESTIGATOR CONTACT DETAILS If you require further information or if you have any problems concerning this project please contact your orthopaedic surgeon, Professor David Wood / Mr Greg Janes, or the principal researcher: Bree Evans Senior Orthopaedic Physiotherapist Hollywood Private Hospital, Monash Avenue, Nedlands WA 6009 Telephone (08) 9346 6384, pager 6103 ETHICAL APPROVAL The Hollywood Private Hospital Research Ethics Committee and the Human Research Ethics Office of The University of Western Australia have given approval for the study. If you have any concerns about this study please do not hesitate to contact Dr Terry Bayliss, Chairperson, Research Ethics Committee Hollywood Private Hospital, Monash Avenue, Nedlands WA 6009. Telephone (08) 9346 6345
49
Appendix B
PATIENT CONSENT FORM
TITLE: Comparison of Two Continuous Passive Motion Regimens following Total
Knee Arthroplasty INVESTIGATOR: Bree Evans To be completed by the participant of the study:
1. Have you read the information sheet about this study? Yes No 2. Have you had an opportunity to ask questions and discuss this study?
Yes No
3. Have you received satisfactory answers to all your questions? Yes No
4. Have you received enough information about this study? Yes No 5. Which Doctor or Physiotherapist has spoken to you about this study? _______________________ 6. Do you understand that you are free to withdraw from this study at any time without giving a reason and without
affecting your current or future medical care? Yes No
7. Do you agree to take part in this study? Yes No 8. Have you received a copy of the information sheet and consent form?
Yes No YOU WILL BE GIVEN A COPY OF THIS CONSENT FORM ____________________ ________________________ ____________ Participant’s Name Participant’s Signature Date
____________________ ________________________ ____________ Person Obtaining Consent Signature Date
50
Appendix C
Recruitment Flow Diagram
Assessed for eligibility (n=78)
Excluded (n=23 ) Not meeting inclusion
criteria (n=16) Declined to participate
(n=7)
Analysed (n=18)
Excluded from analysis
(epidural commenced in theatre) (n=5)
Lost to follow-up (refused to return for measurements, moved to country) (n=4)
Allocated to Group A (n=27)
Received allocated
intervention (n=27)
Lost to follow-up (refused to return for measurements) (n=5)
Allocated to Group B (n=28)
Received allocated
intervention (n=28)
Analysed (n=20)
Excluded from analysis
(epidural commenced in theatre or no intra-articular injection) (n=3) Excluded from analysis (epidural commenced in theatre) (n=1)
Allocation
Analysis
Follow-Up
Randomized (n=55)
Enrolment
51
Appendix D
Functional Activity Score (FAS)
A = No limitation (Activity unrestricted by pain)
B = Mild limitation (Activity is mild to moderately restricted by pain)
C = Severe limitation (Ability to perform activity is severely restricted)
52
Appendix E
SF-36 HEALTH SURVEY
INSTRUCTIONS: This survey asks for your views about your health. This information will help keep track of how you feel and how you are able to do your usual activities. Answer every question by marking the answer as indicated. If you are unsure about how to answer a question, please give the best answer you can. 1. In general, would you say your health is:
(circle one) Excellent………………… 1 Very good……………….. 2 Good…………………….. 3 Fair……………………… 4 Poor…………………….. 5
2. Compared to one year ago, how would you rate your health in general now?
Much better now than one year ago…….. 1 Somewhat better now than one year ago.. 2 About the same as one year ago………... 3 Somewhat worse now than one year ago.. 4 Much worse now than one year ago……. 5 3. The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? (circle one number on each line)
ACTIVITIES Yes, Limited A Lot
Yes, Limited A Little
No, Not Limited At All
a. Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports
1 2 3
b. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf
1 2 3
c. Lifting or carrying groceries 1 2 3 d. Climbing several flights of stairs 1 2 3 e. Climbing one flight of stairs 1 2 3 f. Bending, kneeling, or stooping 1 2 3 g. Walking more than a mile 1 2 3 h. Walking several blocks 1 2 3 i. Walking one block 1 2 3 j. Bathing or dressing yourself 1 2 3
53
4. During the past 4 weeks, have you had any of the following problems with you work or other regular daily activities as a result of your physical health? (circle one number on each line)
YES NO
a. Cut down on the amount of time you spent on work or other activities
1 2
b. Accomplished less than you would like 1 2 c. Were limited in the kind of work or other activities 1 2 d. Had difficulty performing the work or other activities (for example, it took extra effort)
1 2
5. During the past 4 weeks, have you had any of the following problems with you work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? (circle one number on each line)
YES NO
a. Cut down on the amount of time you spent on work or other activities
1 2
b. Accomplished less than you would like 1 2 c. Didn’t do work or other activities as carefully as usual
1 2
6. During the past 4 weeks, to what extent has you physical health or emotional problems interfered with your normal social activities with family, friends, neighbours, or groups?
(circle one) Not at all………………… 1 Slightly…………………. 2 Moderately……………… 3 Quite a bit………………. 4 Extremely………………. 5
7. How much bodily pain have you had during the past 4 weeks?
(circle one) None…………………… 1 Very mild……………… 2 Mild……………………. 3 Moderate………………. 4 Severe………………. …. 5 Very severe……………. 6
54
8. During the past 4 weeks, how much did pain interfere with your normal work (including work both outside the home and housework?
(circle one) Not at all………………… 1 A little bit………………. 2 Moderately……………… 3 Quite a bit………………. 4 Extremely………………. 5
9. These questions are about how you feel and how things have been with you during the past 4 weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4 weeks –
(circle one number on each line)
All of the Time
Most of the Time
A good Bit of the
Time
Some of the Time
A Little of the Time
None of the Time
a. Did you feel full of pep?
1 2 3 4 5 6
b. Have you been a very nervous person?
1 2 3 4 5 6
c. Have you felt so down in the dumps that nothing could cheer you up?
1 2 3 4 5 6
d. Have you felt calm and peaceful?
1 2 3 4 5 6
e. Did you have a lot of energy?
1 2 3 4 5 6
f. Have you felt downhearted and blue?
1 2 3 4 5 6
g. Did you feel worn out? 1 2 3 4 5 6 h. Have you been a happy person?
1 2 3 4 5 6
i. Did you feel tired? 1 2 3 4 5 6 10. During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)?
(circle one) All of the time…………… 1 Most of the time…………. 2 Some of the time………… 3 A little of the time……….. 4 None of the time…………. 5
55
11. How TRUE or FALSE is each of the following statements for you? (circle one number on each line)
Definitely True
Mostly True
Don’t Know
Mostly False
Definitely False
a. I seem to get sick a little easier than other people
1 2 3 4 5
b. I am as healthy as anybody I know
1 2 3 4 5
c. I expect my health to get worse
1 2 3 4 5
d. My health is excellent 1 2 3 4 5
Copyright © 1992 Medical Outcomes Trust
56
Appendix F
Data Collection Sheet
Patient Code:_________________ Time Post-Op
Pre-Op Day 0 Day 1 Day 2 Day 3 Day 4 3 mths
DATE:
TIME:
Pain FAS (A/B/C)
VAS (0-10) (av)
VAS (0-10) (max)
Analgesia/
Anti-inflamm
Epi When started:
Drug:
Dose:
When ceased:
PCA When started:
Drug:
Dose:
When ceased:
Knee Active Flex (o)
Knee Active/ Assisted Flex (o)
Knee Extension (o)
Quads Lag (o)
Total Blood Loss (mls)
Time drain removed
57
Patient Code:_________________
Time Post-Op
Pre-Op Day 0 Day 1 Day 2 Day 3 Day 4 3 mths
DATE:
QOL - SF-36
PCS
MCS
LOS (days)
MUA YES / NO
Height (m)
Weight (kg)
BMI
Gender
Age
Side of Surgery
PMHx
Complications
58
Appendix G
Raw Data
ID NO SEX AGE SIDE SURGEON ANAESTHETIST TREATMENT TREAT2 ANAESTHETIC
INTRA ARTICULAR
1 1 71 1 0 0 0 0 0 0
2 0 60 0 0 0 1 1 0 0
3 1 45 1 0 2 1 1 0 0
4 0 61 0 0 2 0 0 0 0
5 0 68 1 0 0 0 0 0 0
6 1 66 1 0 0 0 0 1 0
7 1 63 0 0 0 0 0 0 0
8 0 64 0 0 0 0 0 0 0
10 0 71 0 0 0 1 1 0 0
11 1 60 1 0 0 0 0 0 0
12 1 67 1 0 2 0 0 0 0
13 1 54 0 0 0 0 0 0 0
14 0 62 1 0 3 1 1 0 0
15 1 69 1 0 0 0 0 0 0
16 0 69 1 0 0 1 1 0 0
17 0 70 1 1 1 0 0 1 0
20 1 74 0 0 0 0 0 0 0
21 1 73 1 1 1 1 2 1 0
23 1 73 0 0 0 1 1 1 0
24 1 78 1 0 2 1 1 0 0
25 0 74 1 0 0 1 1 1 0
26 0 78 0 0 0 1 1 0 0
28 0 54 1 0 0 1 2 0 0
30 1 77 0 1 1 0 0 1 0
32 0 70 0 0 0 0 0 0 0
37 0 52 1 0 0 1 1 0 0
40 1 62 0 0 0 1 1 0 0
41 0 74 1 1 1 0 0 1 0
45 0 77 1 0 0 1 1 0 0
46 0 78 1 0 0 1 1 0 0
47 0 74 0 0 0 1 1 0 0
48 1 78 0 0 0 0 0 0 0
49 0 66 0 0 0 0 0 0 0
50 0 67 0 0 0 1 1 0 0
51 1 54 1 1 1 1 1 1 0
52 1 64 1 0 2 1 1 1 0
53 1 70 0 0 2 0 0 0 0
54 0 69 1 1 1 1 1 0 0
Sex: 0=Female
1=Male Side: 0=Left 1=Right Surgeon 0=Surgeon A 1=Surgeon B Anaesthetist 0= Anaesthetist A 1= Anaesthetist B 2= Anaesthetist C 3= Anaesthetist D Treatment 0=48 hours CPM 1=No routine CPM Treat 2 0=48 hours CPM 1=No CPM 2=CPM required 1 hour/day Anaesthetic 0=CSE 1=GA Intra-Articular 0=Intra-articular injection 1=No intra-articular injection
59
PMH ID NO
1 OA, (L) THR, HTN, High Chol
2 OA, (R) TKR, Rev (R) TKR, Depression, Hysterectomy, Appendectomy
3 OA, angina
4 OA, hysterectomy, GORD
5 OA, diverticular disease, HTN, (R) knee meniscal repair, (L) knee meniscectomy, pneumonia, LBP
6 OA, AMI, Appendectomy, angina
7 OA, RCR
8 OA, HTN, appendectomy, hysterectomy
10 OA, epilepsy, OP
11 OA, LBP, psoritic arthritis, (L) sh, bilat knee scope
12 OA, IHD, CABGx4, NIDDM, HTN, High chol, asthma
13 OA, bowel Sx, bilat acromioplasty, LBP
14 OA, (L) mastectomy
15 OA, Gout, (L) THR, gall bladder
16 OA, (L) TKR, HTN
17 OA, HTN, hysterectomy, gall bladder, appendectomy, discectomy, LBP, diabetes II, hemicolectomy
20 OA, AF, High chol, HTN, Bowel Resection, (R) TKR
21 OA, SLE, (R) RCR, (L) TKR, (L) knee MUA
23 OA, Gout, High chol, (R) THR
24 OA, appendectomy
25 OA, Inflammatory arthritis, lung Ca, Depression, SLE, HTN
26 OA, HTN, appendectomy, ventricular irregular ectopic beat
28 OA, hysterectomy, (R) MACI, R/O pituitary tumour
30 OA, (R) TKR, prostatectomy
32 OA, HTN, (L) THR, (R) TKR, B12 deficiency, High chol
37 OA, hysterectomy
40 OA
41 OA, gall bladder, depression, appendectomy, hysterectomy
45 OA, HTN, cardiac stents x 2
46 OA, HTN, Hypothyroid, high chol, bilat RCR, glucose intolerance
47 OA, breast Ca - bilat mastectomy, HTN, IBS
48 OA, colon Ca – resection
49 OA, PVNS (R) foot/ankle, disc protrusion L5/S1, partial thyroidectomy
50 OA, hysterectomy, appendectomy
51 OA, Appendectomy, LBP
52 OA, HTN
53 OA, HTN, DM II, Gout
54 OA, LBP, hemithyroidectomy, NIDDM, HTN
60
ID NO COMPLICATIONS HEIGHT
WEIGHT BMI
HIGH_ PAIN EPIDURAL PRE 3MTH PRE 3MTH
1 0 1.71 95.2 95.3 32.6 32.6 3 0
2 0 1.60 74.0 72.1 28.9 28.2 4 0
3 0 1.77 85.9 85.8 27.4 27.4 0 0
4 2 1.64 79.4 77.5 29.5 28.8 0 0
5 0 1.60 71.1 73.0 27.8 28.5 1 0
6 0 1.72 72.5 69.0 24.5 23.3 0 0
7 0 1.78 100.9 96.2 31.8 30.3 0 0
8 0 1.60 72.4 72.4 28.3 28.3 0 0
10 0 1.68 69.7 70.4 24.7 24.9 0 0
11 0 1.86 89.0 91.7 25.7 26.5 0 0
12 4 1.69 81.5 80.4 28.5 28.2 0 0
13 0 1.88 83.9 84.8 23.7 24.0 1 0
14 0 1.60 62.8 63.8 24.5 24.9 0 0
15 0 1.70 86.5 87.5 29.9 30.3 0 0
16 0 1.74 65.4 66.8 21.6 22.1 0 0
17 0 1.57 99.0 98.6 40.2 40.0 0 0
20 0 1.88 92.3 91.4 26.1 25.9 1 0
21 0 1.69 68.8 71.6 24.1 25.1 0 0
23 0 1.74 88.5 88.4 29.2 29.2 0 0
24 0 1.69 70.3 70.6 24.6 24.7 0 0
25 0 1.57 71.0 70.6 28.8 28.6 0 0
26 0 1.54 64.2 62.2 27.1 26.2 0 0
28 0 1.62 66.2 63.2 25.2 24.1 0 0
30 0 1.79 105.5 106.6 32.9 33.3 3 0
32 0 1.61 73.0 73.1 28.2 28.2 1 0
37 0 1.65 76.8 80.1 28.2 29.4 0 0
40 0 1.71 91.0 91.4 31.1 31.3 0 0
41 0 1.68 90.2 81.7 31.9 28.9 0 0
45 1 1.49 58.1 56.2 26.2 25.3 0 0
46 4 1.61 79.7 81.3 30.7 31.3 0 0
47 0 1.61 71.6 71.6 27.6 27.6 0 0
48 3 1.75 75.2 77.4 24.6 25.3 0 0
49 0 1.65 69.3 68.5 25.4 25.2 1 0
50 0 1.64 68.4 67.3 25.4 25.0 1 0
51 0 1.78 104.3 102.6 32.9 32.4 0 0
52 0 1.67 73.9 73.6 26.5 26.4 0 0
53 0 1.74 81.4 80.2 26.9 26.5 0 0
54 0 1.64 58.5 58.2 21.8 21.6 0 0
Complications 0=nil 1=Fluid overload
2=DVT 3=Wound ooze
4=AF High Pain 0=nil 1=Epidural commenced on ward 2=FNB commenced on ward 3=CPM ceased 4=Epidural + FNB commenced on ward Epidural 0=No epidural started in theatre
1=Epidural started in theatre
61
ID NO
FAS VAS AV VAS MAX
PRE D0 D1 D2 D3 D4 3MTH PRE D0 D1 D2 D3 3MTH PRE D0 D1 D2 D3 3MTH
1 1 2 2 2 2 2 1 0 2 2 3 0 0 0 4 5 10 4 3
2 2 3 3 2 2 2 1 7 9 8 8 7 0 8 10 10 10 10 2
3 1 2 2 2 2 2 1 6 8 5 7 3 2 7 10 10 10 7 2
4 1 3 3 3 2 2 1 0 5 4 2 2 0 8 8 9 5 4 3
5 1 3 3 3 2 2 1 5 8 2 4 1 2 8 10 9 8 2 6
6 1 2 2 2 2 2 1 2 1 2 1 1 1 8 8 8 6 6 1
7 1 2 2 2 2 2 1 6 5 3 3 2 2 8 8 8 5 4 4
8 1 2 2 2 2 2 1 3 5 2 1 1 0 6 7 4 2 2 0
10 1 2 2 2 2 2 1 7 3 1 0 0 0 8 8 4 2 3 0
11 1 2 2 2 2 2 1 5 5 3 2 3 1 6 7 7 7 6 5
12 1 2 2 2 2 2 1 3 2 2 2 6 3 4 2 10 5 8 6
13 1 3 2 2 2 2 1 6 7 5 4 3 4 9 10 9 8 7 8
14 1 2 2 2 2 2 1 1 5 4 4 4 0 2 8 7 8 8 2
15 1 2 2 2 2 1 4 5 6 4 2 1 8 8 8 8 8 2
16 2 2 2 2 2 2 1 0 6 4 3 3 0 6 10 10 8 6 3
17 2 2 2 2 2 2 2 0 6 4 2 4 2 5 8 10 6 4 5
20 1 2 2 2 2 2 1 0 7 6 4 1 0 5 9 8 8 7 1
21 1 2 3 2 2 2 1 3 4 8 5 3 2 4 7 10 10 6 4
23 1 2 2 2 2 2 1 2 3 2 2 1 1 5 4 4 4 4 2
24 1 2 2 2 2 1 1 4 5 6 5 0 0 7 6 7 5 6 0
25 1 2 2 2 2 2 1 5 8 5 5 5 3 6 10 9 10 8 5
26 1 2 2 2 2 2 1 3 4 2 2 2 1 5 8 9 8 8 2
28 1 2 2 2 2 2 1 4 4 1 1 1 4 8 7 6 6 5 6
30 2 2 2 2 2 2 1 5 6 6 5 4 1 10 7 9 8 6 4
32 1 2 2 2 2 2 1 2 5 1 2 2 2 8 10 5 5 5 4
37 1 2 2 2 2 2 1 3 3 4 3 5 0 7 6 8 8 8 2
40 2 2 2 2 2 2 1 5 5 4 3 0 0 8 8 8 8 7 3
41 1 2 2 2 2 2 1 3 6 4 3 3 0 4 10 10 9 10 7
45 2 2 2 2 2 2 1 5 7 6 4 3 5 10 10 7 7 6 6
46 1 3 3 2 2 2 1 2 7 8 6 2 1 4 10 10 10 5 5
47 1 2 2 2 2 2 1 3 6 6 4 3 0 5 8 8 7 5 2
48 1 2 2 2 2 2 1 0 0 0 0 0 0 5 2 3 2 2 1
49 1 3 2 2 2 2 1 5 5 3 2 2 0 8 8 5 3 3 3
50 2 3 2 2 2 2 1 3 5 5 3 0 0 4 10 8 7 6 3
51 1 2 2 2 2 2 1 3 3 3 2 0 0 4 9 7 7 7 3
52 1 2 2 2 2 2 1 1 0 0 0 0 0 9 1 8 7 7 3
53 1 2 2 2 2 2 1 4 0 0 2 0 0 8 0 0 8 8 2
54 1 2 2 2 2 2 1 3 6 4 4 0 0 6 10 9 8 9 7
FAS 1=A 2=B 3=C
62
ID NO
AKF AAKF EXT QL
PRE D4 3MTH PRE D4 3MTH PRE D4 3MTH PRE D4 3MTH
1 110 95 120 110 100 120 0 0 0 0 15 0
2 110 85 110 115 90 115 10 5 5 0 5 10
3 95 70 95 100 75 100 0 0 0 0 10 5
4 110 90 120 115 100 120 5 10 5 0 15 15
5 135 90 130 140 95 130 0 5 0 5 20 5
6 120 110 130 125 115 135 5 10 5 0 10 0
7 115 95 105 120 95 105 5 10 5 0 15 10
8 120 110 120 120 110 120 0 5 0 5 5 5
10 140 115 135 140 120 135 10 5 0 0 0 0
11 120 100 130 125 105 130 15 5 5 0 15 0
12 130 105 120 130 110 125 0 20 5 0 5 0
13 140 90 125 140 95 125 0 10 5 5 20 5
14 140 90 100 140 95 100 0 5 0 0 30 10
15 115 100 120 120 100 120 0 10 0 0 5 5
16 125 100 130 125 100 130 5 5 0 0 20 5
17 125 90 115 130 95 115 0 5 0 0 15 5
20 125 95 130 125 100 130 0 5 0 0 10 0
21 130 60 100 130 65 100 10 10 10 0 20 10
23 125 110 130 130 115 130 10 10 10 0 5 5
24 125 120 135 125 120 140 10 0 0 5 5 5
25 120 100 130 125 105 130 5 5 0 0 0 5
26 130 110 140 130 110 140 0 0 0 0 10 0
28 125 95 110 125 100 110 0 5 10 0 5 5
30 110 85 105 115 90 105 5 10 5 10 0 5
32 110 90 100 110 95 105 5 5 5 0 15 5
37 135 110 120 135 115 120 10 0 5 0 30 5
40 120 70 120 120 85 120 10 5 0 0 40 10
41 110 80 100 115 90 100 10 5 5 5 30 10
45 115 85 105 120 90 105 0 5 5 5 20 5
46 125 90 120 125 90 120 15 20 10 5 0 5
47 120 100 130 125 100 130 10 0 5 5 5 5
48 130 110 125 130 115 125 0 5 5 5 35 10
49 115 95 110 115 100 115 5 10 5 5 5 5
50 130 90 120 130 95 120 0 5 0 5 20 10
51 120 90 120 120 95 120 10 5 5 0 15 5
52 125 110 125 125 110 125 0 0 0 5 0 0
53 140 100 125 140 105 125 0 10 10 0 5 5
54 135 75 125 135 85 125 5 5 5 10 10 0
63
ID NO LOS
BLOOD _LOSS MUA
SF 36
PRE 3MTHS
PCS MCS PCS MCS
1 5 1300 0 53.4 59.1 53.2 56.9
2 7 200 0 24.2 30.1 50.8 46.1
3 10 850 0 25.2 60.6 46.6 59.8
4 9 1460 0 38.1 49.8 40.3 60.5
5 7 720 0 21.7 65.1 30.5 60.2
6 5 1090 0 46.0 59.0 49.5 63.1
7 5 860 0 35.0 67.2 41.6 59.5
8 5 800 0 42.7 55.3
10 5 330 0 38.5 52.7 37.3 64.6
11 6 1805 0 44.4 50.7 34.6 52.7
12 8 810 0 49.6 60.4 38.9 64.2
13 12 1290 0 28.9 65.2 31.6 64.5
14 5 380 1 44.5 60.0 42.7 61.8
15 3 1050 0 27.4 68.2 55.0 63.1
16 5 770 0 30.4 38.7 47.0 49.0
17 7 1010 0 35.6 62.8 46.2 57.7
20 6 1220 0 40.6 55.1 51.3 59.5
21 11 800 0 43.9 56.5 38.5 60.5
23 5 1170 0 45.0 63.1 54.1 59.3
24 4 1170 0 28.8 70.9 57.8 59.4
25 10 430 0 27.0 32.0 29.9 46.6
26 4 600 0 42.3 66.9 51.1 65.3
28 5 1330 0 33.9 65.3 35.5 58.0
30 7 1030 0 33.6 53.8 46.8 33.4
32 5 600 0 41.0 63.7 40.3 65.2
37 6 870 0 37.8 57.2 52.1 54.1
40 6 1250 0 29.9 61.5 46.7 62.2
41 7 630 0 38.6 45.0 52.7 54.9
45 14 260 0 35.2 48.6 47.4 35.4
46 8 680 0 38.6 52.6 37.5 54.1
47 6 270 0 24.4 51.1 49.0 52.3
48 10 1400 0 38.1 64.1 44.6 57.6
49 6 670 0 29.4 57.0
50 6 500 0 23.9 62.9 42.1 61.9
51 6 800 0 27.4 60.4 45.2 61.3
52 4 860 0 53.5 61.4 53.7 62.1
53 7 590 0 31.4 57.2 47.9 58.5
54 6 660 0 38.8 66.6 50.0 63.2
MUA 0=No 1=Yes
64
ID NO
PCA EPIDURAL
DRUG
DOSE
TIME CEASED DRUG
DOSE
D0 D1 D2 D3 TOTAL D0 D1 D2
1 0 66.0 98.0 32.0 .0 196.00 1240
2 0 92.0 130.0 42.0 .0 264.00 800 1 41.3 26.7
3 0 62.0 186.0 24.0 .0 272.00 830
4 0 54.0 66.0 6.0 .0 126.00 1200
5 0 66.0 18.0 .0 .0 84.00 1100 1 5.9 190.5 69.3
6 0 10.0 148.0 .0 .0 158.00 730
7 0 78.0 166.0 38.0 .0 282.00 830
8 0 86.0 144.0 14.0 .0 244.00 830
10 0 50.0 74.6 .0 .0 124.60 830
11 0 70.0 170.0 46.0 .0 286.00 1140
12 0 60.0 132.0 14.0 .0 206.00 800
13 0 86.0 96.0 6.0 .0 188.00 800 0 71.5 149.9 80.0
14 0 86.0 80.0 2.0 .0 168.00 815
15 0 132.0 162.0 36.0 .0 330.00 700
16 0 64.0 73.9 8.0 .0 145.90 900
17 0 30.0 162.0 70.0 .0 262.00 1350
20 0 26.0 .0 .0 .0 26.00 1630 0 118.6 226.9 82.8
21 0 20.0 118.0 178.0 62.0 378.00 900
23 0 79.6 114.0 .0 .0 193.60 830
24 0 46.0 172.1 58.0 .0 276.10 1100
25 0 130.0 146.6 .0 .0 276.60 830
26 0 44.0 150.0 2.0 .0 196.00 830
28 0 82.0 114.0 2.0 .0 198.00 830
30 0 94.0 96.0 94.0 .0 284.00 2300
32 0 40.0 .0 .0 .0 40.00 1530 1 69.3 252.2 66.6
37 0 102.0 146.0 68.6 .0 316.60 800
40 0 109.4 104.0 44.0 .0 257.40 845
41 0 48.0 168.3 166.5 48.0 430.80 500
45 0 48.0 152.0 38.0 .0 238.00 800
46 0 58.0 84.0 .0 .0 142.00 1130
47 0 16.0 52.0 2.0 .0 70.00 800
48 0 50.0 90.0 4.0 .0 144.00 1300
49 0 24.0 .0 .0 .0 24.00 1700 1 51.2 197.5 71.2
50 0 82.0 50.0 .0 .0 132.00 1225 1 93.7 86.5
51 0 60.0 86.0 10.0 .0 156.00 800
52
53 0 46.0 94.0 42.0 .0 182.00 830
54 0 58.0 56.0 6.0 .0 120.00 900
PCA Drug 0=Fentanyl
Epidural Drug 0=Bupivacaine 0.125% 1=Bupivacaine 0.125% + Fentanyl 5mg/ml
65
ID NO
PARACETAMOL OXYCODONE IR
YES/NO
DOSE
YES/NO
DOSE
D0 D1 D2 D3 D4 D0 D1 D2 D3 D4 TOTAL
1 0 3 4 4 4 4 1
2 0 2 4 4 4 4 0 0 0 80 90 60 230.00
3 0 2 4 4 4 4 0 0 0 65 70 60 195.00
4 0 2 4 4 4 4 0 0 0 50 40 30 120.00
5 0 3 4 4 4 0 0 0 40 40 5 85.00
6 0 3 4 4 4 4 0 0 0 25 30 30 85.00
7 0 3 4 3 4 4 0 0 0 40 50 30 120.00
8 0 3 4 4 4 4 0 0 0 50 20 50 120.00
10 0 2 4 4 4 4 0 0 0 0 10 0 10.00
11 0 2 4 4 4 4 0 0 0 30 40 50 120.00
12 0 2 4 4 4 4 0 0 0 0 10 0 10.00
13 0 3 4 4 4 4 0 0 0 50 45 60 155.00
14 0 2 4 4 4 4 0 0 0 10 15 5 30.00
15 0 3 4 4 0 0 0 30 0 0 30.00
16 0 2 4 4 4 4 0 0 10 30 20 25 85.00
17 0 2 4 4 3 4 0 0 0 30 20 20 70.00
20 0 3 4 4 4 4 0 5 15 10 25 20 75.00
21 0 1 4 4 4 4 0 0 0 0 10 0 10.00
23 0 1 4 3 3 3 1
24 0 3 4 4 4 0 0 0 10 0 0 10.00
25 0 2 4 4 4 4 0 0 0 45 40 30 115.00
26 0 2 4 4 4 0 0 0 10 0 0 10.00
28 0 1 4 4 4 4 0 0 0 30 20 0 50.00
30 0 1 4 4 4 4 0 0 0 0 15 10 25.00
32 0 2 4 4 4 4 0 0 0 35 15 30 80.00
37 0 2 3 4 4 4 0 0 0 40 60 60 160.00
40 0 2 4 4 4 4 0 0 0 45 80 0 125.00
41 0 2 4 4 4 4 0 0 0 0 40 40 80.00
45 0 2 4 3 2 0 0 0 15 0 0 15.00
46 0 2 4 4 2 4 0 0 0 60 30 30 120.00
47 0 2 4 3 4 4 0 0 0 20 20 10 50.00
48 0 3 2 2 3 4 0 0 0 25 5 5 35.00
49 0 3 4 4 4 4 0 0 0 20 0 0 20.00
50 0 2 4 4 4 4 0 0 0 20 10 20 50.00
51 0 2 4 4 4 3 0 0 0 20 20 20 60.00
52 0 4 4 4 3 0 0 15 10 0 0 25.00
53 0 2 4 4 3 4 0 0 0 30 20 25 75.00
54 0 2 4 4 4 4 0 0 0 20 30 0 50.00
Paracetamol 0=Yes 1=No Oxycodone IR 0=Yes 1=No
66
ID NO
TRAMADOL DICLOFENAC
YES/NO
DOSE
YES/NO
DOSE
D0 D1 D2 D3 D4 D0 D1 D2 D3 D4
1 1 0 150 150 150 150
2 1 1
3 0 100 0 0 0 200 0 50 50 150 50
4 0 100 0 0 0 100 0 0 0
5 0 100 0 0 1
6 1 1
7 1 1
8 1 1
10 1 0 50 150 150 150 150
11 1 1
12 0 50 0 0 100 1
13 0 100 100 1
14 1 0 50 150 150
15 1 1
16 1 1
17 1 1
20 1 1
21 1 1
23 1 0 150 150 150 150
24 0 100 100 200 0 100 150 150
25 1 1
26 1 1
28 1 1
30 1 1
32 1 1
37 1 1
40 1 1
41 1 1
45 1 1
46 1 1
47 1 1
48 1 1
49 0 100 50 1
50 1 1
51 1 1
52 1 0 0 50 150 100
53 1 1
54 1 1
Tramadol 0=Yes 1=No Diclofenac 0=Yes 1=No
67
ID NO
MELOXICAM CELECOXIB
YES/NO
DOSE
YES/NO
DOSE
D1 D2 D3 D4 D0 D1 D2 D3 D4
1 1 1
2 1 1
3 1 1
4 0 15 15 15 15 1
5 1 0 100 200 200
6 1 1
7 1 0 100 200 200 200 200
8 1 0 100 200 200 200 200
10 1 1
11 1 0 100 200 200 200 200
12 1 1
13 1 1
14 1 1
15 1 0 100 200 200
16 1 0 200 200 200 200
17 1 0 200 200 200 200 200
20 1 0 100 200 200 200 200
21 1 0 200 200 200 200
23 1 1
24 1 1
25 1 0 100 200 200 200
26 1 0 100 200 200
28 1 0 100 200 200 200
30 1 0 200 200 200 200
32 1 1
37 1 0 100 200 200 200 200
40 1 0 100 200 200 200 100
41 1 1
45 1 0 100 100 200 200
46 1 0 100 100 200 100 200
47 1 0 100 200 200 100 0
48 1 0 100 200 200 200 200
49 1 0 100 200 200 200 200
50 1 0 100 200 200 200
51 1 1
52 1 1
53 1 1
54 1 0 200 200 200 200
Meloxicam 0=Yes 1=No Celecoxib 0=Yes 1=No
68
ID NO
OXYCODONE SR PARECOXIB
EPI_ START
BLOOD_TRANSFUSION
YES/NO
DOSE
YES/ NO
DOSE
YES/ NO NO_OF_ UNITS DAY_POST_OP D2 D3 D4 D1
1 1 1 1 0 2 0
2 1 1 1 0 2 1
3 1 1 0 1
4 1 1 0 0 2 0
5 1 1 1 1
6 1 1 0 1
7 1 1 0 1
8 1 1 0 1
10 1 1 0 0 2 0
11 1 1 0 0 2 0
12 0 10 1 0 1
13 1 1 1 0 1 0
14 0 10 10 10 1 0 1
15 1 1 0 1
16 1 1 0 0 2 0
17 1 1 0 1
20 1 1 1 1
21 0 40 40 1 0 1
23 1 1 0 1
24 1 1 0 1
25 1 1 0 0 2 0
26 1 1 0 1
28 1 0 40 0 0 2 0
30 1 1 1 1
32 1 1 1 1
37 1 1 0 0 1 1
40 1 1 0 0 2 0
41 0 20 40 1 0 1
45 1 1 0 0 2 1
46 0 10 0 20 1 0 1
47 1 1 0 0 2 2
48 1 1 0 1
49 1 1 1 0 2 0
50 1 1 1 0 1 1
51 0 20 40 40 1 0 1
52 1 1 0 1
53 1 1 0 1
54 0 20 20 20 1 0 1
Oxycodone SR 0=Yes 1=No Parecoxib 0=Yes 1=No Epi Start 0=No 1=Started Due to Pain Blood Transfusion 0=Yes 1=No
69
ID NO
HB
PRE D1 D2 D3 D4 D5 D6 POST _OP
1 136 112 104 102 112
2 102 88 85 88 88
3 152 115 95 92 115
4 123 96 96 96
5 153 109 109
6 133 109 109
7 144 129 129
8 157 116 116
10 111 96 96
11 120 107 107
12 149 113 90 95 114 113
13 129 106 94 98 94 106
14 118 96 86 89 96
15 147 119 109 119
16 124 107 107
17 145 123 123
20 151 117 117
21 131 92 81 86 75 75 92
23 153 131 131
24 147 100 100
25 138 119 98 119
26 130 95 91 95
28 103 97 87 91 97
30 148 126 126
32 117 99 99
37 128
40 132 121 117 123 121
41 158 120 120
45 116 82 99 107 107 82
46 123 112 94 95 99 112
47 131 91 88 98 91
48 135 113 102 98 113
49 124 122 123 122
50 113 95 90 95
51 144 113 113
52 128 112 112 112
53 125 107 98 96 107
54 126 114 114
70
Appendix H
Data Analysis
Case Processing Summary
Cases
Valid Missing Total
N Percent N Percent N Percent
SEX * TREATMENT 38 100.0% 0 .0% 38 100.0%
SIDE * TREATMENT 38 100.0% 0 .0% 38 100.0%
SURGEON * TREATMENT 38 100.0% 0 .0% 38 100.0%
ANAESTHETIST * TREATMENT 38 100.0% 0 .0% 38 100.0%
ANAESTHETIC * TREATMENT 38 100.0% 0 .0% 38 100.0%
MUA * TREATMENT 38 100.0% 0 .0% 38 100.0%
EPI_START * TREATMENT 38 100.0% 0 .0% 38 100.0%
BLOOD_TRANSFUSION * TREATMENT 38 100.0% 0 .0% 38 100.0%
SEX * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
SEX Female 7 13 20
Male 11 7 18
Total 18 20 38
Chi-Square Tests
Value Df
Asymp. Sig. (2-
sided)
Exact Sig.
(2-sided)
Exact Sig.
(1-sided)
Pearson Chi-Square 2.591a 1 .107
Continuity Correctionb 1.649 1 .199
Likelihood Ratio 2.619 1 .106
Fisher's Exact Test .193 .099
Linear-by-Linear Association 2.523 1 .112
N of Valid Cases 38
a. 0 cells (.0%) have expected count less than 5. The minimum expected count is 8.53.
b. Computed only for a 2x2 table
71
SIDE * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
SIDE Left 10 7 17
Right 8 13 21
Total 18 20 38
Chi-Square Tests
Value Df
Asymp. Sig.
(2-sided)
Exact Sig.
(2-sided)
Exact Sig. (1-
sided)
Pearson Chi-Square 1.619a 1 .203
Continuity Correctionb .894 1 .344
Likelihood Ratio 1.629 1 .202
Fisher's Exact Test .328 .172
Linear-by-Linear Association 1.577 1 .209
N of Valid Cases 38
a. 0 cells (.0%) have expected count less than 5. The minimum expected count is 8.05.
b. Computed only for a 2x2 table
SURGEON * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
SURGEON A 15 17 32
B 3 3 6
Total 18 20 38
Chi-Square Tests
Value Df
Asymp. Sig.
(2-sided)
Exact Sig. (2-
sided)
Exact Sig.
(1-sided)
Pearson Chi-Square .020a 1 .888
Continuity Correctionb .000 1 1.000
Likelihood Ratio .020 1 .888
Fisher's Exact Test 1.000 .616
Linear-by-Linear Association .019 1 .890
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is 2.84.
b. Computed only for a 2x2 table
72
ANAESTHETIST * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
ANAESTHETIST A 12 13 25
B 3 3 6
C 3 3 6
D 0 1 1
Total 18 20 38
Chi-Square Tests
Value Df
Asymp. Sig. (2-
sided)
Pearson Chi-Square .937a 3 .816
Likelihood Ratio 1.321 3 .724
Linear-by-Linear Association .128 1 .721
N of Valid Cases 38
a. 6 cells (75.0%) have expected count less than 5. The minimum expected count
is .47.
ANAESTHETIC * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
ANAESTHETIC CSE 14 15 29
GA 4 5 9
Total 18 20 38
Chi-Square Tests
Value Df
Asymp. Sig.
(2-sided)
Exact Sig.
(2-sided)
Exact Sig. (1-
sided)
Pearson Chi-Square .040a 1 .841
Continuity Correctionb .000 1 1.000
Likelihood Ratio .041 1 .840
Fisher's Exact Test 1.000 .573
Linear-by-Linear Association .039 1 .843
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is 4.26.
b. Computed only for a 2x2 table
73
MUA * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
MUA No 18 19 37
Yes 0 1 1
Total 18 20 38
Chi-Square Tests
Value Df
Asymp. Sig.
(2-sided)
Exact Sig.
(2-sided)
Exact Sig.
(1-sided)
Pearson Chi-Square .924a 1 .336
Continuity Correctionb .000 1 1.000
Likelihood Ratio 1.308 1 .253
Fisher's Exact Test 1.000 .526
Linear-by-Linear Association .900 1 .343
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is .47.
b. Computed only for a 2x2 table EPI_START* TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
EPI_START Nil 11 18 29
Pain 7 2 9
Total 18 20 38
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig. (2-
sided)
Exact Sig.
(1-sided)
Pearson Chi-Square 4.374a 1 .036
Continuity Correctionb 2.922 1 .087
Likelihood Ratio 4.543 1 .033
Fisher's Exact Test .058 .043
Linear-by-Linear Association 4.259 1 .039
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is 4.26.
b. Computed only for a 2x2 table
74
BLOOD_TRANSFUSION * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
BLOOD_TRANSFUSION YES 5 10 15
NO 13 10 23
Total 18 20 38
Chi-Square Tests
Value Df
Asymp. Sig. (2-
sided)
Exact Sig.
(2-sided)
Exact Sig. (1-
sided)
Pearson Chi-Square 1.958a 1 .162
Continuity Correctionb 1.138 1 .286
Likelihood Ratio 1.986 1 .159
Fisher's Exact Test .198 .143
Linear-by-Linear Association 1.907 1 .167
N of Valid Cases 38
a. 0 cells (.0%) have expected count less than 5. The minimum expected count is 7.11.
b. Computed only for a 2x2 table
Crosstabs
Case Processing Summary
Cases
Valid Missing Total
N Percent N Percent N Percent
HIGH_PAIN * TREATMENT 38 100.0% 0 .0% 38 100.0%
HIGH_PAIN * TREATMENT Crosstabulation
Count
TREATMENT
Total 48 Hours CPM No CPM
HIGH_PAIN Nil 11 18 29
Epidural commenced 5 1 6
CPM ceased 2 0 2
Epi commenced and FNB 0 1 1
Total 18 20 38
75
Group Statistics
TREATMENT N Mean Std. Deviation Std. Error Mean
AGE 48 Hours CPM 18 67.89 6.106 1.439
No CPM 20 66.70 9.761 2.183
BMI_PRE 48 Hours CPM 18 28.803 4.0352 .9511
No CPM 20 26.827 2.9737 .6649
BMI_3MTH 48 Hours CPM 18 28.552 3.9287 .9260
No CPM 20 26.789 2.9652 .6630
HB_PRE_OP 48 Hours CPM 18 138.56 13.307 3.137
No CPM 20 127.50 14.609 3.267
NO_OF_UNITS 48 Hours CPM 5 1.80 .447 .200
No CPM 10 1.80 .422 .133
POST_OP_HB 48 Hours CPM 18 113.50 8.913 2.101
No CPM 19 104.00 13.102 3.006
AKF_PRE 48 Hours CPM 18 121.11 10.369 2.444
No CPM 20 124.50 10.375 2.320
AKF_D4 48 Hours CPM 18 96.11 8.670 2.043
No CPM 20 93.75 16.454 3.679
AKF_3MTH 48 Hours CPM 18 118.33 10.290 2.425
No CPM 20 120.00 12.876 2.879
AAKF_PRE 48 Hours CPM 18 123.61 9.823 2.315
No CPM 20 126.00 8.974 2.007
AAKF_D4 48 Hours CPM 18 100.83 7.717 1.819
No CPM 20 98.00 14.636 3.273
AAKF_3MTH 48 Hours CPM 18 119.44 10.130 2.388
No CPM 20 120.75 12.594 2.816
EXT_PRE 48 Hours CPM 18 3.06 4.249 1.002
No CPM 20 6.00 5.026 1.124
EXT_D4 48 Hours CPM 18 7.78 4.278 1.008
No CPM 20 4.75 4.723 1.056
EXT_3MTH 48 Hours CPM 18 3.61 2.873 .677
No CPM 20 3.50 4.007 .896
QL_PRE 48 Hours CPM 18 2.22 3.078 .726
No CPM 20 2.00 2.991 .669
QL_D4 48 Hours CPM 18 13.33 9.075 2.139
No CPM 20 12.50 11.528 2.578
QL_3MTH 48 Hours CPM 18 5.00 4.201 .990
No CPM 20 5.25 3.432 .767
LOS 48 Hours CPM 18 6.67 2.114 .498
No CPM 20 6.65 2.661 .595
BLOOD_LOSS 48 Hours CPM 18 1018.61 342.610 80.754
76
Group Statistics
TREATMENT N Mean Std. Deviation Std. Error Mean
AGE 48 Hours CPM 18 67.89 6.106 1.439
No CPM 20 66.70 9.761 2.183
BMI_PRE 48 Hours CPM 18 28.803 4.0352 .9511
No CPM 20 26.827 2.9737 .6649
BMI_3MTH 48 Hours CPM 18 28.552 3.9287 .9260
No CPM 20 26.789 2.9652 .6630
HB_PRE_OP 48 Hours CPM 18 138.56 13.307 3.137
No CPM 20 127.50 14.609 3.267
NO_OF_UNITS 48 Hours CPM 5 1.80 .447 .200
No CPM 10 1.80 .422 .133
POST_OP_HB 48 Hours CPM 18 113.50 8.913 2.101
No CPM 19 104.00 13.102 3.006
AKF_PRE 48 Hours CPM 18 121.11 10.369 2.444
No CPM 20 124.50 10.375 2.320
AKF_D4 48 Hours CPM 18 96.11 8.670 2.043
No CPM 20 93.75 16.454 3.679
AKF_3MTH 48 Hours CPM 18 118.33 10.290 2.425
No CPM 20 120.00 12.876 2.879
AAKF_PRE 48 Hours CPM 18 123.61 9.823 2.315
No CPM 20 126.00 8.974 2.007
AAKF_D4 48 Hours CPM 18 100.83 7.717 1.819
No CPM 20 98.00 14.636 3.273
AAKF_3MTH 48 Hours CPM 18 119.44 10.130 2.388
No CPM 20 120.75 12.594 2.816
EXT_PRE 48 Hours CPM 18 3.06 4.249 1.002
No CPM 20 6.00 5.026 1.124
EXT_D4 48 Hours CPM 18 7.78 4.278 1.008
No CPM 20 4.75 4.723 1.056
EXT_3MTH 48 Hours CPM 18 3.61 2.873 .677
No CPM 20 3.50 4.007 .896
QL_PRE 48 Hours CPM 18 2.22 3.078 .726
No CPM 20 2.00 2.991 .669
QL_D4 48 Hours CPM 18 13.33 9.075 2.139
No CPM 20 12.50 11.528 2.578
QL_3MTH 48 Hours CPM 18 5.00 4.201 .990
No CPM 20 5.25 3.432 .767
LOS 48 Hours CPM 18 6.67 2.114 .498
No CPM 20 6.65 2.661 .595
BLOOD_LOSS 48 Hours CPM 18 1018.61 342.610 80.754
No CPM 20 709.00 342.912 76.677
77
Independent Samples Test
Levene's Test for
Equality of
Variances t-test for Equality of Means
F Sig. T df
Sig. (2-
tailed) Mean Diff
Std. Error
Diff
AGE Equal variances assumed 5.194 .029 .444 36 .660 1.189 2.677
Equal variances not assumed .455 32.291 .652 1.189 2.614
BMI_
PRE
Equal variances assumed .862 .359 1.730 36 .092 1.9759 1.1420
Equal variances not assumed 1.703 31.044 .099 1.9759 1.1605
BMI_
3MTH
Equal variances assumed .144 .707 1.571 36 .125 1.7632 1.1221
Equal variances not assumed 1.548 31.493 .132 1.7632 1.1389
HB_PR
E_OP
Equal variances assumed .043 .837 2.429 36 .020 11.056 4.552
Equal variances not assumed 2.441 35.992 .020 11.056 4.529
NO_OF
_UNITS
Equal variances assumed .000 1.000 .000 13 1.000 .000 .235
Equal variances not assumed .000 7.672 1.000 .000 .240
POST_
OP_HB
Equal variances assumed 5.456 .025 2.564 35 .015 9.500 3.705
Equal variances not assumed 2.591 31.837 .014 9.500 3.667
AKF_
PRE
Equal variances assumed .457 .503 -1.006 36 .321 -3.389 3.370
Equal variances not assumed -1.006 35.586 .321 -3.389 3.370
AKF
_D4
Equal variances assumed 6.680 .014 .544 36 .590 2.361 4.339
Equal variances not assumed .561 29.403 .579 2.361 4.209
AKF_
3MTH
Equal variances assumed .557 .460 -.437 36 .664 -1.667 3.810
Equal variances not assumed -.443 35.534 .661 -1.667 3.765
AAKF
_PRE
Equal variances assumed .952 .336 -.784 36 .438 -2.389 3.049
Equal variances not assumed -.780 34.642 .441 -2.389 3.064
AAKF
_D4
Equal variances assumed 5.611 .023 .734 36 .468 2.833 3.860
Equal variances not assumed .757 29.415 .455 2.833 3.744
AAKF_
3MTH
Equal variances assumed .701 .408 -.350 36 .729 -1.306 3.735
Equal variances not assumed -.354 35.583 .726 -1.306 3.692
EXT
_PRE
Equal variances assumed 2.387 .131 -1.938 36 .060 -2.944 1.519
Equal variances not assumed -1.956 35.874 .058 -2.944 1.505
EXT
_D4
Equal variances assumed .214 .646 2.063 36 .046 3.028 1.468
Equal variances not assumed 2.074 35.997 .045 3.028 1.460
EXT_
3MTH
Equal variances assumed 4.243 .047 .097 36 .923 .111 1.143
Equal variances not assumed .099 34.371 .922 .111 1.123
QL_
PRE
Equal variances assumed .073 .789 .226 36 .823 .222 .985
Equal variances not assumed .225 35.336 .823 .222 .987
QL_D4 Equal variances assumed 1.876 .179 .246 36 .807 .833 3.392
Equal variances not assumed .249 35.410 .805 .833 3.350
QL_ Equal variances assumed .203 .655 -.202 36 .841 -.250 1.239
78
3MTH Equal variances not assumed -.200 32.926 .843 -.250 1.253
LOS Equal variances assumed .817 .372 .021 36 .983 .017 .786
Equal variances not assumed .021 35.488 .983 .017 .776
BLOOD
_LOSS
Equal variances assumed .002 .965 2.780 36 .009 309.611 111.363
Equal variances not assumed 2.780 35.589 .009 309.611 111.358
Independent Samples Test
t-test for Equality of Means
95% Confidence Interval of the Difference
Lower Upper
AGE Equal variances assumed -4.240 6.618
Equal variances not assumed -4.134 6.512
BMI_PRE Equal variances assumed -.3403 4.2920
Equal variances not assumed -.3909 4.3426
BMI_3MTH Equal variances assumed -.5126 4.0390
Equal variances not assumed -.5581 4.0846
HB_PRE_OP Equal variances assumed 1.825 20.287
Equal variances not assumed 1.871 20.240
NO_OF_UNITS Equal variances assumed -.508 .508
Equal variances not assumed -.558 .558
POST_OP_HB Equal variances assumed 1.979 17.021
Equal variances not assumed 2.029 16.971
AKF_PRE Equal variances assumed -10.223 3.445
Equal variances not assumed -10.226 3.448
AKF_D4 Equal variances assumed -6.439 11.161
Equal variances not assumed -6.241 10.963
AKF_3MTH Equal variances assumed -9.393 6.060
Equal variances not assumed -9.305 5.972
AAKF_PRE Equal variances assumed -8.572 3.794
Equal variances not assumed -8.611 3.833
AAKF_D4 Equal variances assumed -4.996 10.663
Equal variances not assumed -4.820 10.486
AAKF_3MTH Equal variances assumed -8.881 6.270
Equal variances not assumed -8.797 6.185
EXT_PRE Equal variances assumed -6.025 .136
Equal variances not assumed -5.998 .109
EXT_D4 Equal variances assumed .051 6.005
Equal variances not assumed .067 5.989
EXT_3MTH Equal variances assumed -2.206 2.428
Equal variances not assumed -2.170 2.392
QL_PRE Equal variances assumed -1.776 2.221
79
Equal variances not assumed -1.781 2.225
QL_D4 Equal variances assumed -6.047 7.713
Equal variances not assumed -5.964 7.631
QL_3MTH Equal variances assumed -2.763 2.263
Equal variances not assumed -2.799 2.299
LOS Equal variances assumed -1.577 1.610
Equal variances not assumed -1.558 1.592
BLOOD_LOSS Equal variances assumed 83.756 535.467
Equal variances not assumed 83.676 535.546
TREATMENT N Mean Std. Deviation Std. Error Mean
SF36_PCS_PRE 48 Hours CPM 17 37.224 8.2730 2.0065
No CPM 20 34.660 8.4823 1.8967
SF36_MCS_PRE 48 Hours CPM 17 59.024 6.5720 1.5939
No CPM 20 55.955 11.2451 2.5145
SF36_PCS_3MTH 48 Hours CPM 17 43.982 7.4091 1.7970
No CPM 20 45.750 7.1758 1.6046
SF36_MCS_3MTH 48 Hours CPM 17 58.047 7.2971 1.7698
No CPM 20 56.850 7.6496 1.7105
Independent Samples Test
Levene's Test for
Equality of Variances t-test for Equality of Means
F t t df Sig. (2-tailed)
SF36_PCS
_PRE
Equal variances assumed .218 .644 .927 35 .361
Equal variances not assumed .928 34.304 .360
SF36_MCS
_PRE
Equal variances assumed 3.124 .086 .989 35 .329
Equal variances not assumed 1.031 31.330 .311
SF36_PCS
_3MTH
Equal variances assumed .054 .817 -.736 35 .467
Equal variances not assumed -.734 33.664 .468
SF36_MCS
_3MTH
Equal variances assumed .899 .350 .484 35 .631
Equal variances not assumed .486 34.501 .630
80
Independent Samples Test
t-test for Equality of Means
Mean
Difference
Std. Error
Difference
95% Confidence Interval of the
Difference
Lower Upper
SF36_PCS
_PRE
Equal variances assumed 2.5635 2.7668 -3.0534 8.1805
Equal variances not assumed 2.5635 2.7611 -3.0458 8.1729
SF36_MCS
_PRE
Equal variances assumed 3.0685 3.1014 -3.2277 9.3648
Equal variances not assumed 3.0685 2.9771 -3.0008 9.1378
SF36_PCS
_3MTH
Equal variances assumed -1.7676 2.4027 -6.6453 3.1100
Equal variances not assumed -1.7676 2.4091 -6.6653 3.1300
SF36_MCS
_3MTH
Equal variances assumed 1.1971 2.4710 -3.8193 6.2135
Equal variances not assumed 1.1971 2.4613 -3.8022 6.1964
Case Processing Summary
Cases
Valid Missing Total
N Percent N Percent N Percent
FAS_PRE * TREATMENT 38 100.0% 0 .0% 38 100.0%
FAS_D0 * TREATMENT 38 100.0% 0 .0% 38 100.0%
FAS_D1 * TREATMENT 38 100.0% 0 .0% 38 100.0%
FAS_D2 * TREATMENT 38 100.0% 0 .0% 38 100.0%
FAS_D3 * TREATMENT 38 100.0% 0 .0% 38 100.0%
FAS_D4 * TREATMENT 37 97.4% 1 2.6% 38 100.0%
FAS_3MTH * TREATMENT 38 100.0% 0 .0% 38 100.0%
FAS_PRE * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
FAS_PRE A 16 15 31
B 2 5 7
Total 18 20 38
81
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig.
(2-sided)
Exact Sig.
(1-sided)
Pearson Chi-Square 1.216a 1 .270
Continuity Correctionb .467 1 .494
Likelihood Ratio 1.255 1 .263
Fisher's Exact Test .410 .249
Linear-by-Linear Association 1.184 1 .277
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is 3.32.
b. Computed only for a 2x2 table FAS_D0 * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
FAS_D0 B 14 17 31
C 4 3 7
Total 18 20 38
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig.
(2-sided)
Exact Sig.
(1-sided)
Pearson Chi-Square .329a 1 .566
Continuity Correctionb .024 1 .877
Likelihood Ratio .329 1 .566
Fisher's Exact Test .687 .437
Linear-by-Linear Association .320 1 .572
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is 3.32.
b. Computed only for a 2x2 table
FAS_D1 * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
FAS_D1 B 16 17 33
C 2 3 5
Total 18 20 38
82
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig.
(2-sided)
Exact Sig.
(1-sided)
Pearson Chi-Square .125a 1 .723
Continuity Correctionb .000 1 1.000
Likelihood Ratio .126 1 .722
Fisher's Exact Test 1.000 .552
Linear-by-Linear Association .122 1 .727
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is 2.37.
b. Computed only for a 2x2 table
FAS_D2 * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
FAS_D2 B 16 20 36
C 2 0 2
Total 18 20 38
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig. (2-
sided)
Exact Sig. (1-
sided)
Pearson Chi-Square 2.346a 1 .126
Continuity Correctionb .647 1 .421
Likelihood Ratio 3.113 1 .078
Fisher's Exact Test .218 .218
Linear-by-Linear Association 2.284 1 .131
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is .95.
b. Computed only for a 2x2 table
FAS_D3 * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
FAS_D3 B 18 20 38
Total 18 20 38
FAS_D4 * TREATMENT
83
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
FAS_D4 A 0 1 1
B 17 19 36
Total 17 20 37
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig.
(2-sided)
Exact Sig. (1-
sided)
Pearson Chi-Square .874a 1 .350
Continuity Correctionb .000 1 1.000
Likelihood Ratio 1.254 1 .263
Fisher's Exact Test 1.000 .541
Linear-by-Linear Association .850 1 .357
N of Valid Cases 37
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is .46.
b. Computed only for a 2x2 table
FAS_3MTH * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
FAS_3MTH A 17 20 37
B 1 0 1
Total 18 20 38
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig.
(2-sided)
Exact Sig. (1-
sided)
Pearson Chi-Square 1.141a 1 .285
Continuity Correctionb .003 1 .957
Likelihood Ratio 1.524 1 .217
Fisher's Exact Test .474 .474
Linear-by-Linear Association 1.111 1 .292
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is .47.
b. Computed only for a 2x2 table
84
TREATMENT N Mean Std. Deviation Std. Error Mean
VASAV_PRE 48 Hours CPM 18 2.92 2.211 .521
No CPM 20 3.50 1.906 .426
VASAV_D0 48 Hours CPM 18 4.42 2.439 .575
No CPM 20 5.05 2.164 .484
VASAV_D1 48 Hours CPM 18 3.03 1.882 .444
No CPM 20 4.30 2.342 .524
VASAV_D2 48 Hours CPM 18 2.56 1.294 .305
No CPM 20 3.55 2.114 .473
VASAV_D3 48 Hours CPM 18 2.03 1.576 .372
No CPM 20 2.08 2.066 .462
VASAV_3MTH 48 Hours CPM 18 1.06 1.211 .286
No CPM 20 .95 1.504 .336
VASMAX_PRE 48 Hours CPM 18 6.53 2.440 .575
No CPM 20 6.15 2.033 .455
VASMAX_D0 48 Hours CPM 18 7.00 3.010 .709
No CPM 20 8.00 2.384 .533
VASMAX_D1 48 Hours CPM 18 7.06 2.796 .659
No CPM 20 7.95 1.820 .407
VASMAX_D2 48 Hours CPM 18 6.28 2.347 .553
No CPM 20 7.50 2.115 .473
VASMAX_D3 48 Hours CPM 18 5.31 2.321 .547
No CPM 20 6.55 1.701 .380
VASMAX_3MTH 48 Hours CPM 18 3.61 2.253 .531
No CPM 20 3.10 1.889 .422
Independent Samples Test
Levene's Test for
Equality of Variances t-test for Equality of Means
F Sig. t df
Sig. (2-
tailed)
VASAV_
PRE
Equal variances assumed 1.060 .310 -.873 36 .388
Equal variances not assumed -.866 33.807 .392
VASAV_
D0
Equal variances assumed .444 .509 -.848 36 .402
Equal variances not assumed -.843 34.241 .405
VASAV_
D1
Equal variances assumed .725 .400 -1.832 36 .075
Equal variances not assumed -1.854 35.579 .072
VASAV_
D2
Equal variances assumed 3.053 .089 -1.725 36 .093
Equal variances not assumed -1.768 31.918 .087
VASAV_
D3
Equal variances assumed 2.263 .141 -.079 36 .938
Equal variances not assumed -.080 35.108 .937
85
VASAV_
3MTH
Equal variances assumed .424 .519 .237 36 .814
Equal variances not assumed .239 35.596 .812
VASMAX
_PRE
Equal variances assumed .578 .452 .520 36 .606
Equal variances not assumed .515 33.262 .610
VASMAX
_D0
Equal variances assumed .807 .375 -1.141 36 .261
Equal variances not assumed -1.127 32.382 .268
VASMAX
_D1
Equal variances assumed 4.174 .048 -1.180 36 .246
Equal variances not assumed -1.155 28.702 .258
VASMAX
_D2
Equal variances assumed .849 .363 -1.689 36 .100
Equal variances not assumed -1.679 34.463 .102
VASMAX
_D3
Equal variances assumed 3.296 .078 -1.899 36 .066
Equal variances not assumed -1.868 30.936 .071
VASMAX
_3MTH
Equal variances assumed 1.013 .321 .760 36 .452
Equal variances not assumed .753 33.368 .457
Independent Samples Test
t-test for Equality of Means
Mean
Difference
Std. Error
Difference
95% Confidence Interval of the
Difference
Lower Upper
VASAV
_PRE
Equal variances assumed -.583 .668 -1.938 .771
Equal variances not assumed -.583 .673 -1.952 .785
VASAV
_D0
Equal variances assumed -.633 .747 -2.147 .881
Equal variances not assumed -.633 .751 -2.160 .893
VASAV
_D1
Equal variances assumed -1.272 .694 -2.680 .136
Equal variances not assumed -1.272 .686 -2.665 .120
VASAV
_D2
Equal variances assumed -.994 .577 -2.164 .175
Equal variances not assumed -.994 .563 -2.141 .152
VASAV
_D3
Equal variances assumed -.047 .601 -1.267 1.173
Equal variances not assumed -.047 .593 -1.251 1.156
VASAV
_3MTH
Equal variances assumed .106 .446 -.799 1.010
Equal variances not assumed .106 .441 -.789 1.000
VASMAX
_PRE
Equal variances assumed .378 .726 -1.095 1.850
Equal variances not assumed .378 .733 -1.113 1.869
VASMAX
_D0
Equal variances assumed -1.000 .876 -2.778 .778
Equal variances not assumed -1.000 .887 -2.807 .807
86
VASMAX
_D1
Equal variances assumed -.894 .758 -2.431 .643
Equal variances not assumed -.894 .775 -2.480 .691
VASMAX
_D2
Equal variances assumed -1.222 .724 -2.690 .245
Equal variances not assumed -1.222 .728 -2.700 .256
VASMAX
_D3
Equal variances assumed -1.244 .655 -2.574 .085
Equal variances not assumed -1.244 .666 -2.603 .114
VASMAX
_3MTH
Equal variances assumed .511 .672 -.852 1.874
Equal variances not assumed .511 .679 -.869 1.891
87
Case Processing Summary
Cases
Valid Missing Total
N Percent N Percent N Percent
PCA_DRUG * TREATMENT 37 97.4% 1 2.6% 38 100.0%
EPI_DRUG * TREATMENT 7 18.4% 31 81.6% 38 100.0%
PARACETAMOL * TREATMENT 38 100.0% 0 .0% 38 100.0%
OXYCODONE IR * TREATMENT 38 100.0% 0 .0% 38 100.0%
TRAMADOL * TREATMENT 38 100.0% 0 .0% 38 100.0%
DICLOFENAC * TREATMENT 38 100.0% 0 .0% 38 100.0%
MELOXICAM * TREATMENT 38 100.0% 0 .0% 38 100.0%
CELECOXIB * TREATMENT 38 100.0% 0 .0% 38 100.0%
OXYCODONE SR * TREATMENT 38 100.0% 0 .0% 38 100.0%
PARECOXIB * TREATMENT 38 100.0% 0 .0% 38 100.0%
PCA_DRUG * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
PCA_DRUG Fentanyl 18 19 37
Total 18 19 37
EPI_DRUG * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
EPI_DRUG Bupiv 0.125% 2 0 2
Bupiv 0.125% + Fentanyl 5mg/ml 3 2 5
Total 5 2 7
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig.
(2-sided)
Exact Sig. (1-
sided)
Pearson Chi-Square 1.120a 1 .290
Continuity Correctionb .018 1 .895
Likelihood Ratio 1.646 1 .200
Fisher's Exact Test 1.000 .476
Linear-by-Linear Association .960 1 .327
N of Valid Cases 7
a. 4 cells (100.0%) have expected count less than 5. The minimum expected count is .57.
b. Computed only for a 2x2 table
88
PARACETAMOL * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
PARACETAMOL YES 18 20 38
Total 18 20 38
OXYCODONE _IR* TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
OXYCODONE_IR YES 17 19 36
NO 1 1 2
Total 18 20 38
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig.
(2-sided)
Exact Sig. (1-
sided)
Pearson Chi-Square .006a 1 .939
Continuity Correctionb .000 1 1.000
Likelihood Ratio .006 1 .939
Fisher's Exact Test 1.000 .730
Linear-by-Linear Association .006 1 .940
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is .95.
b. Computed only for a 2x2 table TRAMADOL * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
TRAMADOL YES 5 2 7
NO 13 18 31
Total 18 20 38
89
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig. (2-
sided)
Exact Sig. (1-
sided)
Pearson Chi-Square 1.992a 1 .158
Continuity Correctionb .985 1 .321
Likelihood Ratio 2.033 1 .154
Fisher's Exact Test .222 .161
Linear-by-Linear Association 1.940 1 .164
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is 3.32.
b. Computed only for a 2x2 table
DICLOFENAC * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
DICLOFENAC YES 2 6 8
NO 16 14 30
Total 18 20 38
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig.
(2-sided)
Exact Sig. (1-
sided)
Pearson Chi-Square 2.034a 1 .154
Continuity Correctionb 1.056 1 .304
Likelihood Ratio 2.121 1 .145
Fisher's Exact Test .238 .152
Linear-by-Linear Association 1.980 1 .159
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is 3.79.
b. Computed only for a 2x2 table
MELOXICAM * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
MELOXICAM YES 1 0 1
NO 17 20 37
Total 18 20 38
90
Chi-Square Tests
Value Df
Asymp. Sig.
(2-sided)
Exact Sig. (2-
sided)
Exact Sig. (1-
sided)
Pearson Chi-Square 1.141a 1 .285
Continuity Correctionb .003 1 .957
Likelihood Ratio 1.524 1 .217
Fisher's Exact Test .474 .474
Linear-by-Linear Association 1.111 1 .292
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is .47.
b. Computed only for a 2x2 table CELECOXIB * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
CELECOXIB YES 10 12 22
NO 8 8 16
Total 18 20 38
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig. (2-
sided)
Exact Sig. (1-
sided)
Pearson Chi-Square .077a 1 .782
Continuity Correctionb .000 1 1.000
Likelihood Ratio .077 1 .782
Fisher's Exact Test 1.000 .520
Linear-by-Linear Association .075 1 .785
N of Valid Cases 38
a. 0 cells (.0%) have expected count less than 5. The minimum expected count is 7.58.
b. Computed only for a 2x2 table
OXYCODONE_SR * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
OXYCODONE_SR YES 2 5 7
NO 16 15 31
Total 18 20 38
91
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig. (2-
sided)
Exact Sig. (1-
sided)
Pearson Chi-Square 1.216a 1 .270
Continuity Correctionb .467 1 .494
Likelihood Ratio 1.255 1 .263
Fisher's Exact Test .410 .249
Linear-by-Linear Association 1.184 1 .277
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is 3.32.
b. Computed only for a 2x2 table
PARECOXIB * TREATMENT
Crosstab
Count
TREATMENT
Total 48 Hours CPM No CPM
PARECOXIB YES 0 1 1
NO 18 19 37
Total 18 20 38
Chi-Square Tests
Value df
Asymp. Sig.
(2-sided)
Exact Sig. (2-
sided)
Exact Sig. (1-
sided)
Pearson Chi-Square .924a 1 .336
Continuity Correctionb .000 1 1.000
Likelihood Ratio 1.308 1 .253
Fisher's Exact Test 1.000 .526
Linear-by-Linear Association .900 1 .343
N of Valid Cases 38
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is .47.
b. Computed only for a 2x2 table
Group Statistics
TREATMENT N Mean Std. Deviation Std. Error Mean
PCA_DOSE_D0 48 Hours CPM 18 59.222 29.6103 6.9792
No CPM 19 67.842 29.1052 6.6772
PCA_DOSE_D1 48 Hours CPM 15 120.687 45.1235 11.6508
No CPM 19 109.958 41.3335 9.4826
PCA_DOSE_D2 48 Hours CPM 14 40.607 45.1468 12.0660
No CPM 17 28.506 44.6346 10.8255
PCA_DOSE_D3 48 Hours CPM 1 48.000 . .
No CPM 1 62.000 . .
92
OXYCODONE_IR_D0 48 Hours CPM 1 5.00 . .
No CPM 0a . . .
OXYCODONE_IR _D1 48 Hours CPM 1 15.00 . .
No CPM 2 12.50 3.536 2.500
OXYCODONE_IR _D2 48 Hours CPM 14 33.21 11.866 3.171
No CPM 17 31.18 21.472 5.208
OXYCODONE_IR _D3 48 Hours CPM 16 25.94 15.190 3.797
No CPM 19 27.63 27.907 6.402
OXYCODONE_IR _D4 48 Hours CPM 16 25.31 18.481 4.620
No CPM 14 22.86 22.931 6.129
TRAMADOL_D0 48 Hours CPM 0a . . .
No CPM 1 100.00 . .
TRAMADOL_D1 48 Hours CPM 1 50.00 . .
No CPM 2 50.00 70.711 50.000
TRAMADOL_D2 48 Hours CPM 3 66.67 57.735 33.333
No CPM 2 50.00 70.711 50.000
TRAMADOL_D3 48 Hours CPM 5 40.00 54.772 24.495
No CPM 2 100.00 141.421 100.000
TRAMADOL_D4 48 Hours CPM 5 50.00 50.000 22.361
No CPM 1 200.00 . .
DICLOFENAC_D0 48 Hours CPM 0a . . .
No CPM 2 25.00 35.355 25.000
DICLOFENAC_D1 48 Hours CPM 2 125.00 35.355 25.000
No CPM 5 100.00 50.000 22.361
DICLOFENAC_D2 48 Hours CPM 2 75.00 106.066 75.000
No CPM 6 116.67 51.640 21.082
DICLOFENAC_D3 48 Hours CPM 2 75.00 106.066 75.000
No CPM 6 141.67 20.412 8.333
DICLOFENAC_D4 48 Hours CPM 2 75.00 106.066 75.000
No CPM 4 125.00 50.000 25.000
MELOXICAM_D1 48 Hours CPM 1 15.00 . .
No CPM 0a . . .
MELOXICAM _D2 48 Hours CPM 1 15.00 . .
No CPM 0a . . .
MELOXICAM _D3 48 Hours CPM 1 15.00 . .
No CPM 0a . . .
MELOXICAM _D4 48 Hours CPM 1 15.00 . .
No CPM 0a . . .
CELECOXIB_D0 48 Hours CPM 8 112.50 35.355 12.500
No CPM 5 100.00 .000 .000
CELECOXIB_D1 48 Hours CPM 9 200.00 .000 .000
No CPM 12 150.00 52.223 15.076
93
CELECOXIB_D2 48 Hours CPM 10 190.00 31.623 10.000
No CPM 12 200.00 .000 .000
CELECOXIB_D3 48 Hours CPM 9 200.00 .000 .000
No CPM 12 183.33 38.925 11.237
CELECOXIB_D4 48 Hours CPM 9 200.00 .000 .000
No CPM 10 170.00 67.495 21.344
OXYCODONE_SR _D2 48 Hours CPM 0a . . .
No CPM 4 15.00 5.774 2.887
OXYCODONE_SR _D3 48 Hours CPM 2 15.00 7.071 5.000
No CPM 5 22.00 17.889 8.000
OXYCODONE_SR _D4 48 Hours CPM 1 40.00 . .
No CPM 5 26.00 13.416 6.000
PARECOXIB_D1 48 Hours CPM 0a . . .
No CPM 1 40.00 . .
a. t cannot be computed because at least one of the groups is empty.
Independent Samples Test
Levene's Test for
Equality of
Variances t-test for Equality of Means
F Sig. t df
Sig. (2-
tailed)
Mean
Difference
Std. Error
Difference
PCA_DOSE_
D0
Equal variances assumed .005 .944 -.893 35 .378 -8.6199 9.6543
Equal variances not
assumed
-.892 34.815 .378 -8.6199 9.6589
PCA_DOSE_
D1
Equal variances assumed .239 .628 .722 32 .476 10.7288 14.8633
Equal variances not
assumed
.714 28.846 .481 10.7288 15.0220
PCA_DOSE_
D2
Equal variances assumed .002 .967 .747 29 .461 12.1013 16.1920
Equal variances not
assumed
.747 27.745 .462 12.1013 16.2105
PCA_DOSE_
D3
Equal variances assumed . . . 0 . -14.0000 .
Equal variances not
assumed
. . . -14.0000 .
OXYCODON
E_IR_D1
Equal variances assumed . . .577 1 .667 2.500 4.330
Equal variances not
assumed
. . . 2.500 .
OXYCODON
E_IR_D2
Equal variances assumed 5.069 .032 .317 29 .754 2.038 6.431
Equal variances not
assumed
.334 25.715 .741 2.038 6.097
OXYCODON
E_IR_D3
Equal variances assumed 3.827 .059 -.217 33 .830 -1.694 7.809
Equal variances not
assumed
-.228 28.639 .822 -1.694 7.444
94
OXYCODON
E_IR_D4
Equal variances assumed .697 .411 .325 28 .748 2.455 7.563
Equal variances not
assumed
.320 24.983 .752 2.455 7.675
TRAMADOL_
D1
Equal variances assumed . . .000 1 1.000 .000 86.603
Equal variances not
assumed
. . . .000 .
TRAMADOL_
D2
Equal variances assumed .150 .724 .293 3 .789 16.667 56.928
Equal variances not
assumed
.277 1.899 .809 16.667 60.093
TRAMADOL_
D3
Equal variances assumed 40.238 .001 -.896 5 .411 -60.000 66.933
Equal variances not
assumed
-.583 1.123 .655 -60.000 102.956
TRAMADOL_
D4
Equal variances assumed . . -2.739 4 .052 -150.000 54.772
Equal variances not
assumed
. . . -150.000 .
DICLOFENA
C_D1
Equal variances assumed .804 .411 .630 5 .556 25.000 39.686
Equal variances not
assumed
.745 2.793 .514 25.000 33.541
DICLOFENA
C_D2
Equal variances assumed 5.672 .055 -.797 6 .456 -41.667 52.264
Equal variances not
assumed
-.535 1.163 .677 -41.667 77.907
DICLOFENA
C_D3
Equal variances assumed 36.300 .001 -1.732 6 .134 -66.667 38.490
Equal variances not
assumed
-.883 1.025 .536 -66.667 75.462
DICLOFENA
C_D4
Equal variances assumed 4.000 .116 -.843 4 .447 -50.000 59.293
Equal variances not
assumed
-.632 1.230 .624 -50.000 79.057
CELECOXIB
_D0
Equal variances assumed 3.291 .097 .777 11 .453 12.500 16.079
Equal variances not
assumed
1.000 7.000 .351 12.500 12.500
CELECOXIB
_D1
Equal variances assumed . . 2.854 19 .010 50.000 17.522
Equal variances not
assumed
3.317 11.000 .007 50.000 15.076
CELECOXIB
_D2
Equal variances assumed 6.136 .022 -1.101 20 .284 -10.000 9.083
Equal variances not
assumed
-1.000 9.000 .343 -10.000 10.000
CELECOXIB
_D3
Equal variances assumed 10.179 .005 1.276 19 .217 16.667 13.060
Equal variances not
assumed
1.483 11.000 .166 16.667 11.237
CELECOXIB
_D4
Equal variances assumed 10.330 .005 1.330 17 .201 30.000 22.564
Equal variances not
assumed
1.406 9.000 .193 30.000 21.344
OXYCODON Equal variances assumed 2.595 .168 -.513 5 .630 -7.000 13.646
95
E_SR _D3 Equal variances not
assumed
-.742 4.804 .493 -7.000 9.434
OXYCODON
E_SR_D4
Equal variances assumed . . .953 4 .395 14.000 14.697
Equal variances not
assumed
. . . 14.000 .
Independent Samples Test
t-test for Equality of Means
95% Confidence Interval of the
Difference
Lower Upper
PCA_DOSE_D0 Equal variances assumed -28.2191 10.9794
Equal variances not assumed -28.2322 10.9925
PCA_DOSE_D1 Equal variances assumed -19.5468 41.0044
Equal variances not assumed -20.0018 41.4594
PCA_DOSE_D2 Equal variances assumed -21.0150 45.2176
Equal variances not assumed -21.1181 45.3207
PCA_DOSE_D3 Equal variances assumed . .
Equal variances not assumed . .
OXYCODONE_IR_D1 Equal variances assumed -52.519 57.519
Equal variances not assumed . .
OXYCODONE_IR_D2 Equal variances assumed -11.114 15.190
Equal variances not assumed -10.502 14.578
OXYCODONE_IR_D3 Equal variances assumed -17.582 14.194
Equal variances not assumed -16.927 13.539
OXYCODONE_IR_D4 Equal variances assumed -13.037 17.948
Equal variances not assumed -13.352 18.263
TRAMADOL_D1 Equal variances assumed -1100.390 1100.390
Equal variances not assumed . .
TRAMADOL_D2 Equal variances assumed -164.502 197.835
Equal variances not assumed -255.544 288.878
TRAMADOL_D3 Equal variances assumed -232.056 112.056
Equal variances not assumed -1074.513 954.513
TRAMADOL_D4 Equal variances assumed -302.072 2.072
Equal variances not assumed . .
DICLOFENAC_D1 Equal variances assumed -77.017 127.017
Equal variances not assumed -86.358 136.358
DICLOFENAC_D2 Equal variances assumed -169.551 86.218
Equal variances not assumed -757.262 673.929
DICLOFENAC_D3 Equal variances assumed -160.848 27.515
Equal variances not assumed -972.340 839.007
DICLOFENAC_D4 Equal variances assumed -214.623 114.623
Equal variances not assumed -703.792 603.792
96
CELECOXIB_D0 Equal variances assumed -22.889 47.889
Equal variances not assumed -17.058 42.058
CELECOXIB_D1 Equal variances assumed 13.326 86.674
Equal variances not assumed 16.819 83.181
CELECOXIB_D2 Equal variances assumed -28.947 8.947
Equal variances not assumed -32.622 12.622
CELECOXIB_D3 Equal variances assumed -10.668 44.002
Equal variances not assumed -8.065 41.398
CELECOXIB_D4 Equal variances assumed -17.607 77.607
Equal variances not assumed -18.283 78.283
OXYCODONE_SR_D3 Equal variances assumed -42.077 28.077
Equal variances not assumed -31.552 17.552
OXYCODONE_SR _D4 Equal variances assumed -26.805 54.805
Equal variances not assumed . .
Descriptives – GROUP A
Descriptive Statistics
N Minimum Maximum Mean Std. Deviation
AGE 18 54 78 67.89 6.106
BMI_PRE 18 23.7 40.2 28.803 4.0352
AKF_PRE 18 110 140 121.11 10.369
AKF_D4 18 80 110 96.11 8.670
AKF_3MTH 18 100 130 118.33 10.290
AAKF_PRE 18 110 140 123.61 9.823
AAKF_D4 18 90 115 100.83 7.717
AAKF_3MTH 18 100 135 119.44 10.130
EXT_PRE 18 0 15 3.06 4.249
EXT_D4 18 0 20 7.78 4.278
EXT_3MTH 18 0 10 3.61 2.873
QL_PRE 18 0 10 2.22 3.078
QL_D4 18 0 35 13.33 9.075
QL_3MTH 18 0 15 5.00 4.201
LOS 18 3 12 6.67 2.114
BLOOD_LOSS 18 590 1805 1018.61 342.610
HB_PRE_OP 18 117 158 138.56 13.307
POST_OP_HB 18 96 129 113.50 8.913
SF36_PCS_PRE 17 21.7 53.4 37.224 8.2730
SF36_MCS_PRE 17 45.0 68.2 59.024 6.5720
SF36_PCS_3MTH 17 30.5 55.0 43.982 7.4091
SF36_MCS_3MTH 17 33.4 65.2 58.047 7.2971
97
Descriptives – GROUP B
Descriptive Statistics
N Minimum Maximum Mean Std. Deviation
AGE 20 45 78 66.70 9.761
BMI_PRE 20 21.6 32.9 26.827 2.9737
AKF_PRE 20 95 140 124.50 10.375
AKF_D4 20 60 120 93.75 16.454
AKF_3MTH 20 95 140 120.00 12.876
AAKF_PRE 20 100 140 126.00 8.974
AAKF_D4 20 65 120 98.00 14.636
AAKF_3MTH 20 100 140 120.75 12.594
EXT_PRE 20 0 15 6.00 5.026
EXT_D4 20 0 20 4.75 4.723
EXT_3MTH 20 0 10 3.50 4.007
QL_PRE 20 0 10 2.00 2.991
QL_D4 20 0 40 12.50 11.528
QL_3MTH 20 0 10 5.25 3.432
LOS 20 4 14 6.65 2.661
BLOOD_LOSS 20 200 1330 709.00 342.912
HB_PRE_OP 20 102 153 127.50 14.609
POST_OP_HB 19 82 131 104.00 13.102
SF36_PCS_PRE 20 23.9 53.5 34.660 8.4823
SF36_MCS_PRE 20 30.1 70.9 55.955 11.2451
SF36_PCS_3MTH 20 29.9 57.8 45.750 7.1758
SF36_MCS_3MTH 20 35.4 65.3 56.850 7.6496
Group Statistics
TREATMENT N Mean Std. Deviation Std. Error Mean
Total_PCA_dose 48 Hours CPM 18 194.0444 110.53086 26.05237
No CPM 20 196.2400 89.91085 20.10468
Total_oxycodone_IR_dose 48 Hours CPM 17 76.7647 41.90544 10.16356
No CPM 19 73.6842 66.49649 15.25534
Independent Samples Test
Levene's Test for
Equality of
Variances t-test for Equality of Means
F Sig. t df
Sig. (2-
tailed)
Total_PCA_dose Equal variances assumed .603 .442 -.067 36 .947
Equal variances not assumed -.067 32.852 .947
Total_oxycodone_IR_
dose
Equal variances assumed 4.252 .047 .164 34 .871
Equal variances not assumed .168 30.717 .868
98
Independent Samples Test
t-test for Equality of Means
Mean
Difference
Std. Error
Difference
95% Confidence Interval of
the Difference
Lower Upper
Total_PCA_dose Equal variances assumed -2.19556 32.54727 -68.20448 63.81336
Equal variances not assumed -2.19556 32.90781 -69.15845 64.76734
Total_oxycodone_IR_
dose
Equal variances assumed 3.08050 18.78869 -35.10272 41.26371
Equal variances not assumed 3.08050 18.33094 -34.31967 40.48066
Paired Samples Statistics
Mean N Std. Deviation Std. Error Mean
Pair 1 SF36_PCS_PRE 36.017 36 8.4175 1.4029
SF36_PCS_3MTH 45.000 36 7.3295 1.2216
Pair 2 SF36_MCS_PRE 57.375 36 9.5319 1.5887
SF36_MCS_3MTH 57.458 36 7.5070 1.2512
Paired Samples Correlations
N Correlation Sig.
Pair 1 SF36_PCS_PRE &
SF36_PCS_3MTH
36 .169 .324
Pair 2 SF36_MCS_PRE &
SF36_MCS_3MTH
36 .627 .000
Paired Samples Test
Paired Differences
Mean Std. Deviation Std. Error Mean
Pair 1 SF36_PCS_PRE -
SF36_PCS_3MTH
-8.9833 10.1841 1.6973
Pair 2 SF36_MCS_PRE -
SF36_MCS_3MTH
-.0833 7.5801 1.2634
Paired Samples Test
Paired Differences
t df
Sig. (2-
tailed)
95% Confidence Interval of the
Difference
Lower Upper
Pair 1 SF36_PCS_PRE -
SF36_PCS_3MTH
-12.4291 -5.5375 -5.293 35 .000
Pair 2 SF36_MCS_PRE -
SF36_MCS_3MTH
-2.6481 2.4814 -.066 35 .948