ORIGINAL ARTICLE HIP - ANESTHESIAA randomized controlled.docx

ORIGINAL ARTICLE � HIP - ANESTHESIA
A randomized controlled trial of postoperative analgesia
following
total knee replacement: transdermal Fentanyl patches
versus patient controlled analgesia (PCA)
M. J. Hall1 • S. M. Dixon2 • M. Bracey3 • P. MacIntyre4 • R. J.
Powell3 •
A. D. Toms3
Received: 13 November 2014 / Accepted: 12 February 2015 /
Published online: 11 March 2015
� Springer-Verlag France 2015
Abstract
Background This randomized controlled trial compared a
standard patient controlled analgesic (PCA) regime with a
transdermal and oral Fentanyl regime for post-operative
pain management in patients undergoing total knee
replacement.
Methods One hundred and ninety-six patients undergoing
total knee replacement were recruited. Pre- and post-op-

eratively Visual Analogue Score (VAS), Oxford Knee
Score, Health Anxiety and Depression Score and Brief Pain
Inventory Score were completed. According to the day 1,
VAS score patients were randomly allocated to either a
PCA regime or a Fentanyl transdermal/oral regime. Patient
reported outcomes were measured until the patients were
discharged.
Results The results demonstrate that in terms of analgesic
effect, day of discharge and side effect profile the two
regimes are comparable.
Conclusions We conclude that a Fentanyl transdermal
regime provides adequate analgesic effect comparable to a
standard PCA regime in conjunction with a low side effect
profile. Using a transdermal analgesic system provides ef-
ficient continuous delivery enabling a smooth transition
from hospital to home within the first week. Transdermal
Fentanyl provides an alternative analgesic regime that can
provide an equivalent analgesic effect so as to enable a

satisfactory outcome for the patient in terms of function
and pain.
Level of evidence II.
Keywords Total knee replacement � Post-operative
analgesia � Patient controlled analgesia � Fentanyl patches
Introduction
Knee replacement surgery has proved a successful and
cost-effective method for relieving pain and restoring
function in patients with osteoarthritis [1]. However, pain
management after knee replacement surgery remains a
significant problem, with patients reporting this as a major
concern prior to surgery [2]. Implementing relevant pre-
operative screening methods may facilitate the identifica-
tion of individuals at high risk of experiencing high post-
operative pain [3]. Despite recent advances in the aetiology
of pain, improved pain treatments and the development of
clinical guidelines for pain assessment, the under-treatment
of post-operative pain remains a challenge to both surgeon

and anaesthetist. Recent studies have clearly demonstrated
that patient satisfaction following total knee replacement is
multifactorial with the most significant predictor of dis-
satisfaction being a painful total knee replacement [1].
Providing effective pain relief in the post-operative pe-
riod is essential to enable early mobilisation and reha-
bilitation, minimise immobility-related complications,
maximise functional outcome and reduce hospital stay.
Many different methods of delivering adequate analgesia
are currently employed but one of the most established is
intravenous (IV) patient controlled analgesia (PCA). This
provides the benefit of self-titrated IV opioid medication
& M. J. Hall
[email protected]
1
Yeovil District Hospital, Higher Kingston,
Yeovil BA21 4AT, UK
2
Royal Cornwall Hospital, Truro, UK
3
Royal Devon & Exeter Hospital, Exeter, UK

4
Nelson Bay District Hospital, Nelson, New Zealand
123
Eur J Orthop Surg Traumatol (2015) 25:1073–1079
DOI 10.1007/s00590-015-1621-6
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1621-6&domain=pdf
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enabling active participation in the patient’s own post-op-
erative management compared to a more generic, orally
delivered analgesia. The disadvantages are the cost of PCA
pumps along with the monitoring required and nursing time
to manage the systems appropriately.
The literature provides no clear answers as to the best
method of post-operative pain relief, with studies showing
PCA [4] and regional techniques [5, 6] both providing good
analgesia to enable rehabilitation. The major drawback of
morphine can be the side effect profile, including nausea,

constipation and itching, whereas with regional analgesia
the reliability and duration of action can be problematic.
Fentanyl has formed the mainstay of intra-operative
analgesia and has many beneficial features. In the lozenge
form, it has a very rapid onset and can reach peak activity
within 20 min compared to 40–60 min for oral morphine
[7]. For this reason, the main clinical application of oral
fentanyl lozenges is in the field of oncology for manage-
ment of breakthrough pain.
The aim of this randomized controlled study was to
compare two analgesic regimes, PCA and Fentanyl (in a
transdermal and oral form) and demonstrate that a trans-
dermal Fentanyl patch can provide comparable post-op-
erative analgesia to a standard PCA regime in terms of pain
and side effect profile without compromising rehabilitation
and discharge times. Post-operatively on day 1, we divided
patients into a low and high pain group based on a pain
score to see if this enabled an accurate prediction of pain

requirements during the subsequent post-operative period.
Patients and methods
All patients undergoing a unilateral total knee replacement
at the Royal Devon and Exeter Hospital were invited to
take part in the trial, which included all surgeons per-
forming knee replacement surgery within the trust. Patients
were excluded from the study if they were unable to walk
twenty metres or climb three stairs for any reason other
than pain in the affected joint, trauma and refusal or in-
ability to give valid consent. Pre-operatively the study
group completed the Oxford Knee Score (OKS) [17],
Health Anxiety Depression Score (HADS) and Brief Pain
Inventory Score (BPI). Participants in the trial were pre-
scribed paracetamol (1 g QDS), an anti-inflammatory
(Diclofenac 50 mg BD) and oral morphine (10–20 mg two
hourly) as required.
Patients were given a pain diary on day 1 and asked to
score the pain on movement of the limb using a ten-point

Visual Analogue Score (VAS). If this score was 6/10 or
more they were entered into the high pain group (HPG),
and less than six entered the low pain group (LPG). An
independent statistician using a sealed envelope technique
carried out randomization of the HPG into the two treat-
ment arms. The LPG remained on the routine analgesic
regime. In the HPG, patients were randomized to either
intravenous morphine administered through a PCA pump,
or a Fentanyl patch with oral Fentanyl in the form of a
lozenge that can be taken two hourly prior to exercise or
for breakthrough pain. The doses of morphine in the PCA
were 1 mg bolus with a 5 min lockout and no 4-h limit or
background infusion. The doses of Fentanyl patch were
12.5 mcg for patients over 65 years and 25 mcg for pa-
tients under 65 years with lozenges up to 400 mcg for
breakthrough pain and up to five 200 mcg lozenges,
whilst waiting for the patch to reach therapeutic plasma
levels. The lozenges were titrated against signs of

lightheadedness.
Each day until discharge, patients attempted standard
physiotherapy tasks as part of their physiotherapy regime
and then scored their pain using the VAS which is scored
zero to ten (where the lower the score the less the patient’s
pain). Patients were also asked to complete the BPI score
with 1–4 being mild, 4–6 moderate and 7–10 severe pain.
These scores were completed for worst pain, least pain,
average pain, pain currently, pain on activity, pain effect on
mood, pain on walking, pain whilst at work, pain affect on
relations, pain whilst sleeping and pain effect on enjoy-
ment. Pain assessment was carried out on a daily basis until
discharge in the form of a short interview and completion
of the above-mentioned scores. As part of the question-
naires, we recorded the presence of side effects and their
severity and impact on rehabilitation.
For this study, full ethical approval was granted from the
local ethics committee as well as full approval from the

Medicines and Healthcare Products Regulatory Agency
(MHRA). Research and Development reference from
Royal Devon and Exeter Hospital: 612163 and Research
Ethics Committee reference: 06/Q2102/57.
Statistical analysis
Based on preliminary data for PCA that we can expect a
15 % reduction in pain worst score after 4 days (which is
what we saw on average), and if there is truly no difference
between the standard and experimental treatment, then 50
patients are required to be 80 % sure that the limits of a
two-sided 90 % confidence interval will exclude a differ-
ence between the standard and experimental group of more
than 30 %.
Continuous outcome data were tested for normality us-
ing the Shapiro Wilks test. If the data were found to be
normally distributed, central tendency was expressed using
means and dispersion using standard deviation. If the data
proved not to be Gaussian, and could not easily be trans-

formed, they were summarised using medians and
1074 Eur J Orthop Surg Traumatol (2015) 25:1073–1079
123
interquartile ranges and comparisons were made using
nonparametric tests such as the Mann–Whitney U test.
Confidence intervals were derived wherever possible.
Categorical data were summarised as proportions and
percentages as appropriate with associated confidence in-
tervals. A comparison of time to discharge was analysed
using Kaplan–Meier survival analysis. Repeated con-
tinuous measures such as VAS pain, OKS, BPI elements
and HADS were analysed using repeated measures analysis
of variance provided the basic requirements were met. The
first 5 days of data were included as in subsequent days,
too many patients had been discharged to make analysis
feasible.
Results

One hundred and ninety-six patients undergoing unilateral
total knee replacement were recruited into the trial. Of
these 64 subsequently withdrew from the trial after initially
consenting and 25 had incomplete data collection for
analysis and were excluded. This left a total of one hundred
and seven patients in the trial with 69 in the LPG, 38 in the
HPG with sixteen of these receiving Fentanyl patches and
lozenges and 22 receiving a PCA infusion (Fig. 1).
The mean age in the LPG was 68; Fentanyl group 64 and
PCA group 66 years. Patient ages ranged from 41 to
96 years with patients in the LPG tending to be older on
average, but this was not statistically significantly different.
Day of discharge
Kaplan–Meier survivorship analysis comparing the three
groups showed a significant difference in day of discharge
between the three groups. Mean time to discharge was
6.23 days for Fentanyl, 5.95 days for PCA and 4.48 days
in the low pain group (p = 0.007) (Fig. 2).

We also analysed the percentage of patients discharged
by day 5. The LPG had the highest rate of discharge
overall, with forty-two (77.8 %) discharged by this time
period. In the HPG, thirteen (68 %) of the PCA group and
7 (5 %) of the Fentanyl group were discharged by day 5;
however, this difference was not significant (p = 0.284).
Pain scores
Pain scores were analysed at day 5 post-operatively as a
large proportion of patients had been discharged after this
time.
Comparison of VAS scores showed that there was no
significant difference in pain scores on movement
(p = 0.317), rest (p = 0.811), worst pain (p = 0.353) and
night (p = 0.730) between the Fentanyl and PCA groups
(see Table 1).
Both HPG groups (Fentanyl and PCA) showed a sig-
nificant reduction, i.e. pain is better, in BPI Worst score,
BPI Average score, BPI Now score, BPI Activity score,

BPI Mood score, BPI Walk score, BPI Relations score, BPI
Work score, BPI Sleep score, BPI Enjoy score (see
Table 2). The reduction in all BPI Worst scores was similar
in both of the treatment groups (i.e. fentanyl from 6.81 to
4.22) and PCA from 7.44 to 4.48). BPI (Now) showed a
significant difference between the LPG and HPG
(p 0.001); however, all other modalities of the BPI score
showed no significant difference.
Side effects
Using repeated measures ANOVA showed that the side
effect scores between the Fentanyl and PCA groups were
relatively low (1.271–1.417) and did not vary significantly
across the 4 days. There was no significant difference in
side effect score between the two groups, PCA (mean
1.368) and Fentanyl (mean 1.339) (p = 0.887).
Oxford Knee Scores
Both HPG groups (Fentanyl and PCA) demonstrated a
significant reduction in OKS score (p 0.001). However,
there was no significant difference between the two

treatment groups (p = 0.974) (see Table 3). The reduc-
tion in OKS score was similar in both of the treatment
groups, dropping from a mean of 36.9–28.72 in the
Fentanyl group and 37.16–28.58 in the PCA group (see
Table 3).
Anxiety and depression: HADS scores
Both HPG groups (Fentanyl and PCA) demonstrated a
significant reduction in mean HADS score; 10.16–7.91 in
the Fentanyl group and 12.89–7.06 in the PCA group
(p = 0.004). Comparison of HADS Score for the LPG and
HPG showed no significant difference (p = 0.615).
Discussion
The results from this study show that a post-operative
regime of transdermal Fentanyl patches compares to that of
a more conventional PCA regime in terms of analgesic
effect, day of discharge and side effect profile. By using the
VAS score pre-operatively, we showed that patients can be
allocated into a high or low pain group and consequently a

Eur J Orthop Surg Traumatol (2015) 25:1073–1079 1075
123
targeted analgesic regime can be implemented to suit the
individuals analgesic requirements.
Over the last decade, the emphasis on peri-operative
pain management in joint replacement surgery has made
significant advances, to the extent that many consider it to
be the most substantial advance in clinical practice [8]. A
4-year follow-up study concluded that pain is a common
persistent problem in the community with a relatively high
incidence and low recovery rate [9]. Ip et al. [10] in a
systematic review found that preexisting pain, anxiety, age
and type of surgery are the most significant factors for the
intensity of post-operative pain with type of surgery, age
and psychological distress, the three most important pre-
dictive factors for analgesic consumption.
It is well established that more than half the numbers of

patients undergoing lower limb joint replacement surgery
Assessed for eligibility (n=196)
Excluded (n=90)
♦ Not meeting inclusion criteria (n=26)
♦ Declined to participate (n=64)
♦ Other reasons (n=0)
Analysed (n=14) at day 4
♦ Excluded from analysis (n=0)
Discontinued intervention
(discharged home):-
day 1, n=0
day 2, n=0
day 3, n=1 (1)
day 4, n=1 (2)
day 5, n=1 (3)
day 6, n=6 (9)
day 7, n=4 (10)
(Cumulative totals in brackets)
Allocated to Fentanyl intervention (n=15)
♦ Received allocated intervention (n=15)
♦ Did not receive allocated intervention
(n=0)
(discharged home):-
day 1, n=0)
day 2, n=0)
day 3, n=1 (1)
day 4, n=3 (4)
day 5, n=7 (11)

day 6, n=10 (18)
day 7, n=0 (18)
Allocated to PCA intervention (n=23)
♦ Received allocated intervention
(n=23)
♦ Did not receive allocated
intervention (n=0)
Allocation
Analysis
Follow-Up
High pain group.
Randomized (n=38)
Enrollment
Observational group (low pain) (n=68)
(discharged home):-
day 1, n=0
day 2, n=0
day 3, n=3 (3)
day 4, n=20 (23)
day 5, n=27 (50)
day 6, n=5 (55)

day 7, n=4 (59)
Fig. 1 Consort diagram of study patients
123
receive suboptimal analgesia especially during the initial
post-operative period [8], with patients now well informed
to their pain management and consider it a high priority
[2]. However, the importance of delivering adequate
analgesia reaches beyond that of clinical duty with recog-
nition that inadequate pain management can increase the
possibility of developing a poor outcome. Severe post-op-
erative pain results in longer hospital stay, increased opioid
use with resultant side effects and lower patient mood.
Studies have demonstrated that those patients that receive
suboptimal analgesia post-operative have higher levels of

arthrofibrosis and diminished range of motion [5, 11, 12].
In this study, analysis of pre-operative BPI pain score data
demonstratedthattheHPG had a higherpercentage ofpatients
reporting a BPI greater than 5, 61 %, compared to the LPG
which only had 40 %. Early identification of patients likely to
require additional or alternative methods of post-operative
analgesia means maximising rehabilitation enabling
achievement of physiotherapy targets sooner ultimately
Fig. 2 Kaplan–Meier curve of discharge days
Table 1 Mean VAS pain scores for pain on movement, at rest,
worst and at night. A comparison of fentanyl and PCA
interventions in the high
pain group and also a comparison of the high pain group with
the low pain group
Intervention Mean VAS pain score
Day Pain on movement Pain at rest Worst pain Pain at night
High pain group
Fentanyl
1 7.33 5.83 7.92 8.20
2 7.08 5.25 7.33 5.50
3 5.83 4.17 7.25 4.50

4 5.42 3.50 6.25 4.00
5 5.33 3.50 6.67 3.30
PCA
1 7.67 6.58 8.00 7.71
2 7.67 4.58 8.50 4.43
3 6.75 4.33 7.33 5.00
4 6.08 4.17 7.25 3.86
5 5.50 3.50 6.92 2.71
Within subjects comparison
(i.e. changes over time)
F = 4.9 with 4, 88
df, p = 0.001
F = 5.83 with 4, 88
df, p = 0.001
F = 1.94 with 4, 88
df, p = 0.111
F = 17.83 with 4,
88 df, p = 0.001

Main effect: comparison
of fentanyl versus PCA
F = 1.05 with 1, 22
df, p = 0.317
F = 0.06 with 1, 22
df, p = 0.811
F = 0.90 with 1, 22
df, p = 0.353
F = 0.12 with 1,
22 df, p = 0.730
Low pain group
1 3.06 1.88 3.77 3.46
2 5.00 2.29 5.41 2.85
3 4.88 1.65 5.53 1.85
4 4.88 1.53 5.77 1.77
5 4.47 1.06 5.88 1.69
Within subjects comparison
(i.e. changes over time)

F = 2.17 with 4,
156 df, p = 0.095
F = 6.01 with 4,
156 df, p = 0.001
F = 0.89 with 4,
156 df, p = 0.451
F = 19.97 with 4,
112 df, p 0.001
Main effect: comparison
of LPG with HPG
F = 17.87 with 1,
39 df, p 0.001
F = 29.39 with 1,
39 df, p 0.001
F = 19.87 with 1,
39 df, p 0.001
F = 14.54 with 1,
28 df, p = 0.001
123

reducing length of stay. In those patients identified as requir-
ing additional analgesic support post-operatively the Fentanyl
transdermal delivery regime has a distinct advantage of pro-
viding a smooth transition to the home environment.
The use of Fentanyl in orthopaedic surgery is limited
with its most common usage being in management of
breakthrough pain in the palliative care setting. Fentanyl
patches do add to the total narcotic dosage as well as
providing an alternative route for administration of anal-
gesia. However, concerns over unpredictable delivery and
the potential for adverse effects does deter many centres
from using Fentanyl through this method. Using Fentanyl
ionophoretic transdermal systems, Viscusi et al. [13, 14]
demonstrated pain control equivalent to standard morphine
PCA delivery systems in a variety of post-operative pa-
tients, with no significant difference in side effect profiles.
Analysis of the side effect profile in our study showed

similar findings with no significant difference demonstrated
between the Fentanyl group and the PCA group.
From this study, we suggest Fentanyl patches and lozenges
provide a viable alternative to the standard morphine based
regime used in most PCA pumps. Fentanyl in a transdermal
therapeutic system provides several attractive features; firstly
it provides stable plasma concentrations in a relatively short
period of time which are maintained a background steady-
state level, secondly newer formulations are safer and bioe-
quivalent to standard oral preparations. Minville et al. re-
ported on a small group of patients who had a fentanyl patch
applied 10 h prior to total hip arthroplasty. No difference in
respiratory depression was noted between that group and
those who did not receive the patch [15, 16]. However, the
use of fentanyl lozenges in this setting is innovative with the
ability of the oral form of Fentanyl to be rapidly absorbed
through the buccal mucosa providing high plasma levels
rapidly means that its profile is ideally suited to managing

breakthrough pain during the post-operative period.
Current trends favour the multimodal approach that
provide adequate analgesia yet minimise opioid-related
Table 2 Mean (and 95 % CI) BPI scores for worst pain and pain
now
Intervention BPI worst BPI now
High pain group
Fentanyl
Pre 6.81 (5.74–7.89) 4.90 (3.46–6.34)
Post 4.22 (3.15–5.3) 2.43 (1.30–3.56)
PCA
Pre 7.44 (6.56–8.33) 5.39 (4.2–6.57)
Post 4.48 (3.59–5.37) 2.55 (1.62–3.48)
Within subjects comparison (i.e. change over time) F = 6.74
with 1, 29 df; p = 0.015 F = 3.27 with 1, 29 df; p = 0.081
Main effect: comparison of fentanyl versus PCA F = 0.682 with
1, 29 df; p = 0.486 F = 0.21 with 1, 29 df; p = 0.653
Low pain group
Pre 10.11 (8.35–11.87) 3.56 (2.87–4.25)

Post 6.07 (4.57–7.57) 1.24 (0.8–1.68
Within subjects comparison (i.e. change over time) F = 5.64
with 1, 80 df; p = 0.02 F = 5.38 with 1, 80 df; p = 0.023
Comparison of LPG with HPG F = 2.57 with 1, 80 df; p = 0.113
F = 15.51 with 1, 80 df; p 0.001
A comparison of fentanyl and PCA interventions in the high
the low pain group.
Age as a covariate
Table 3 Mean (and 95 % CI) Oxford Knee Score and Hospital
Anxiety and Depression Score
Intervention Pre-OKS Post-OKS Pre-HADS Post-HADS
High pain group
Fentanyl 36.9 (32.61–41.19) 28.72 (25.56–31.89) 10.16 (6.38–
13.95) 7.91 (5.04–10.79)
PCA 37.16 (33.92–40.41) 28.58 (26.19–30.97) 12.89 (9.77–
16.01) 7.06 (4.69–9.43)
Within subjects comparison F = 43.96 with 1, 27 df; p 0.001 F
= 9.93 with 1, 29 df; p = 0.004
Main effect: comparison of fentanyl versus PCA F = 0.001 with
1, 27 df; p = 0.974 F = 0.26 with 1, 29 df; p = 0.615
Low pain group 35.28 (33.34–39.54) 26.70 (25.03–28.37) 10.11
(8.35–11.87) 6.07 (4.57–7.57)
Within subjects comparison F = 4.78 with 1, 78 df; p = 0.032 F

= 5.64 with 1, 79 df; p = 0.02
Comparison of LPG with HPG F = 2.57 with 1, 78 df; p = 0.113
F = 1.42 with 1, 79 df; p = 0.237
A comparison of fentanyl and PCA interventions in the high
the low pain group.
Age as a covariate
123
side effects. From this study, we suggest that the use of
Fentanyl in a transdermal delivery system with oral Fen-
tanyl for breakthrough pain provides equivalent pain re-
lieve compared to the more standard opioid based PCA
systems, which several studies have demonstrated provide
adequate cost-efficient pain relief [2, 4]. However, none of
the theoretical advantages were seen as a practical differ-
ence in our patient group. Early identification of patients
falling into the high pain category means that suitable
analgesic regimes can be planned so as to create an envi-

ronment in which both mentally and physically the patient
is able to undertake progressive rehabilitation.
We know that patient expectations correlate highly with
satisfaction and by managing expectations and considering
the mental health of the patient can all help reduce the risk
of overall dissatisfaction. Post-operative pain relief is one
important aspect in the process of undergoing a knee re-
placement with many global factors pertaining to that in-
dividual playing an important role to the overall outcome.
The benefits of splitting patients into low and high pain
groups results means that those patients at risk of devel-
oping severe acute post-operative pain are identified at an
early stage and specific analgesic regime can be imple-
mented so as to manage the pain appropriately in order that
rehabilitation is not compromised. Central to successful
enhanced recovery programs is providing a platform for
patients to mobilise such that they can be discharged safely
with a minimal length of stay. Multi-modal analgesic

regimes we feel are therefore a key component to these
programs. Managing patients post-operative analgesia and
pain perception efficiently can result in faster rehabilitation
and ultimately improved functional outcome and patient
satisfaction. This study demonstrates the potential benefits
of multi-modal analgesia in enabling a faster rehabilitation
in the initial post-operative period and ultimately improves
outcomes.
Conflict of interest None.
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A randomized controlled trial of postoperative analgesia
following total knee replacement: transdermal Fentanyl patches
versus patient controlled analgesia
(PCA)AbstractBackgroundMethodsResultsConclusionsLevel of
evidenceIntroductionPatients and methodsStatistical
analysisResultsDay of dischargePain scoresSide effectsOxford
Knee ScoresAnxiety and depression: HADS
scoresDiscussionConflict of interestReferences

ORIGINAL ARTICLE HIP - ANESTHESIAA randomized controlled.docx

ORIGINAL ARTICLE HIP - ANESTHESIAA randomized controlled.docx

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