randomized clinical trial of continuous femoral nerve block combined with sciatic nerve block versus...

The Journal of Arthroplasty xxx (2014) xxx–xxx

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The Journal of Arthroplasty

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Randomized Clinical Trial of Continuous Femoral Nerve BlockCombined with Sciatic Nerve Block Versus Epidural Analgesia forUnilateral Total Knee Arthroplasty

Tariq Al-Zahrani, M.D. a, Khaled S. Doais, M.D. b, Fawzi Aljassir, M.D. c, Ibrahim Alshaygy, M.D. c,Waleed Albishi, M.D. c, Abdullah S. Terkawi, M.D. b,d

a Department of Anesthesiology, King Saud University, Riyadh, Saudi Arabiab Department of Anesthesiology, King Fahad Medical City, Riyadh, Saudi Arabiac Department of Orthopedic, King Saud University, Riyadh, Saudi Arabiad Department of Anesthesiology, University of Virginia, Charlottesville, VA

a b s t r a c ta r t i c l e i n f o

The Conflict of Interest statement associated with thidx.doi.org/10.1016/j.arth.2014.07.032.

Reprint requests: Abdullah S. Terkawi, M.D., DeUniversity of Virginia, Charlottesville, VA.

http://dx.doi.org/10.1016/j.arth.2014.07.0320883-5403/© 2014 Elsevier Inc. All rights reserved.

Please cite this article as: Al-Zahrani T, et al,Versus Epidural Analgesia for Unilateral To

Article history:Received 11 April 2014Accepted 28 July 2014Available online xxxx

Keywords:continuous femoral nerve blockepidural analgesiatotal knee arthroplasty

Pain control following total knee arthroplasty (TKA) is crucial to hasten rehabilitation and decrease morbidity.We evaluated whether there is a difference between epidural infusion and continuous femoral nerve blockwith respect to postoperative pain control and rehabilitation course. Fifty patients completed the study. Therewas no statistically significant difference in the pain scores (P = 0.33), morphine consumption (P = 0.09)mean blood pressure or heart rate (P = 0.957, and P = 0.716) between groups. The postoperative dailymobilization (P = 0.80), knee joint range of motion (P = 0.83), and straight leg test (P = 0.99) were alsosimilar between both groups. Patients were highly satisfied with their pain management in both groupswithout statistically significant difference (P = 0.98).

s article can be found at http://

partment of Anesthesiology,

Randomized Clinical Trial of Continuous Femotal Knee Arthroplasty, J Arthroplasty (2014),

© 2014 Elsevier Inc. All rights reserved.

Pain remains one of the major challenges for anesthesiologistsfollowing total knee arthroplasty (TKA). Despite the tremendouswork in this field almost half of the patients still have moderate tosevere pain following TKA [1]. The impact of severe pain after TKA isnot only unpleasant, but may be associated with severe systemiccomplications [1]. Multiple pain management modalities have beenevaluated: patient controlled analgesia (PCA), continuous epiduralinfusion (CEI), “three-in-one” block [2], single shot femoral andsciatic nerve blocks [3], continuous femoral nerve block (CFNB),continuous posterior lumbar plexus block [4], and unilateral spinalanesthesia [5]. However, optimum analgesia after TKA is still anunresolved issue.

A systematic review of these studies has failed to prove superiorityof any one approach over another and has failed to prove utility ofadding sciatic nerve block to femoral nerve block in controllingpostoperative TKA pain [6]. One of the major drawbacks of both FNBand CEI is prolonged motor blockade that prevents early mobilizationthereby increasing the length of stay with persistent quadricepsweakness, and increased risk of falling [7].

It has been found that the use of ultrasound guidance helps toachieve more effective FNB with minimal local anesthetic volume

[8,9]. However, there are few studies that compare the use ofultrasound guided CFNB with CEI, and their results were inconclusiveand contradictory [10–12].

The aim of this randomized clinical trial was to compareultrasound-guided CFNB in addition to single shot sciatic nerveblock by the standard CEI in terms of postoperative pain control,hemodynamic changes, rehabilitation course and patients painmanagement satisfaction.

Methodology

Enrollment

Following institutional review board approval (King SaudUniversity, Riyadh, Saudi Arabia, number E.12.589) patients' consentwas obtained prior to enrollment. Fifty-six patients who werescheduled for unilateral knee total knee arthroplasty (TKA) wererandomized (1:1) in a prospective, parallel, randomized control trial.The study conducted during the period between January 2012 andMay 2013. Patients who planned for unilateral TKA and agedbetween 18 and 75 years regardless of their gender and BMI wereconsidered eligible. Those with bilateral TKA or revision surgery, orhas sickle cell disease, or allergy to local anesthetics were excluded.This study was designed and written according to the CONSORT2010 statement [13].

ral Nerve Block Combined with Sciatic Nerve Blockhttp://dx.doi.org/10.1016/j.arth.2014.07.032

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Randomization

Patients were randomized into two groups: continuous epiduralinfusion (CEI group), and continuous femoral nerve block with singleshot sciatic nerve block (CFNB group). A computerized randomnumber generator was used. Numbers were stored in opaque sealedenvelopes. The patient was asked to select one envelope on themorning of surgery.

Perioperative Management and Procedures

Patients were premedicated with intravenous midazolam (1 to2 mg) in the holding area. The regional analgesia was performed inthe operating theater under standard monitoring (i.e. blood pressure,heart rate, pulse oxymeter and 3-leads EKG). After skin disinfectionwith iodine and covering the block site with a sterile drape,intradermal 2% lidocaine was used for local anesthesia. Procedureswere performed as follow:

• CEI group: an epidural catheter (Portex®, Epidural Maxipack, SmithsMedical, UK) was place at the L3/4 or L4/5 level using a 17G Tuohyneedle then inserted upward by 4 cm. Infused with 0.0625%bupivacaine + fentanyl (2 mcg/ml) with rate 5–10 ml/hour wasstarted after initial bolus of 10 ml of 0.25% bupivacaine + 50 mcgfentanyl preoperatively. We selected to use 0.0625% bupivacaineconcentration to fasten early mobilization as this concentration waspreviously used for walking epidural [14]. The catheter was coveredwith a sterile dressing to avoid dislodging and maintain sterility. Theprocedure performed in a sitting position.

• Ultrasound-guided CFNB: was performed according to the methoddescribed by Koscielniak-Nielsen et al [15]. While the patient was insupine position, a femoral nerve catheter (PAJUNK®, Geisingen,Germany) was place through a Touhy 18G × 100 mm cannula, andinfused at a rate of 5 ml/hour 0.2% bupivacaine after initial bolus of10 ml 0.25% bupivacaine under ultrasound guidance. In addition, allpatients in this group had a single shot sciatic nerve block with15 ml of 0.25% bupivacaine preoperatively under ultrasoundguidance through anterior approach. The catheter was placedperpendicular to the femoral nerve, as a previously described byWang et al [16]. The catheter was sutured to the skin to avoid

Fig. 1. CONSORT 20

Please cite this article as: Al-Zahrani T, et al, Randomized Clinical Trial ofVersus Epidural Analgesia for Unilateral Total Knee Arthroplasty, J Arth

dislodgment then covered with a sterile dressing. All blocks weredone one by senior anesthesiologist (TZ). Blocks were performedunder ultrasound guidance (M-Turbo, SonoSite Inc., Seattle, WA,USA) using a 15-MHz linear transducer.

The efficacy of the epidural and nerve blocks was assessed beforethe induction of anesthesia, by checking the motor and sensory blocksdensity and distribution.

General anesthesia was performed with 1 mcg/kg fentanyl and2 mg/kg propofol, and a laryngeal airway mask (LMA) was insertedthereafter. The patients were mechanically ventilated, and Sevofluranein air/oxygen without N2O was used for maintenance. Intraoperativeboluses of fentanyl (25–50 mcg), fluid, blood pressure and bloodmanagement were administered by the attending anesthesiologistsbased on clinical criteria. After anesthesia emergence, all patients werestarted on a patient-controlled analgesia (PCA) for rescue analgesia. ThePCAwasprogrammed togive1 mgofmorphine sulfatewith a lockoutof8 minutes without background infusion.

Outcome Measurements (End Points)

Primary OutcomesPostoperative pain scores [measuring the numerical rating score

(NRS) in the scale of 0 to 10, where 0 = no pain and 10 = worst painever can tolerate], and postoperative morphine consumption. Each ofthese outcomes was recorded every 6 hours after the patient’sdischarge from post-anesthesia recovery unit (PACU) for up to72 hours. All these measurements were collected by the acute painservice specialized nurses who were unaware of the study.

Secondary Outcomes(1) Postoperative hemodynamic changes, reported as mean blood

pressure (MAP) and heart rate variation in the first 72 hours afterdischarge from PACU. (2) Postoperative rehabilitation course, whichwas assessed by the physiotherapy team (who were unaware of thestudy) once daily as follows: maximum distance that the patient canwalk (in meter) during the rehabilitation section, measuring the rangeof the knee jointmotion using a goniometer, and the straight leg raisingtest (where the patient was asked to rise his leg from supine position asmuch as he/she can) to assess the ipsilateral motor block. (3) Patient

10 flow chart.

Continuous Femoral Nerve Block Combined with Sciatic Nerve Blockroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.07.032


Table 1Demographic and Clinical Characteristics of the Patients.

CharacteristicEpidural group

(n = 25)CFNB

(n = 25) P-value

Age (years) 60 ± 8.5 62 ± 7.5 0.277Gendera

• Male 7 8 1• Female 18 17 1Body mass index (kg/m2) 33 ± 5 33 ± 5 0.696ASA classificationa

• ASA I 2 6 0.263• ASA II 23 19 0.805Duration of surgery (minutes) 123 ± 15 123 ± 19 0.909Tourniquet time (minutes) 119 ± 16 114 ± 24 0.374Intraoperative fentanyl consumption (mcg) 25 ± 38 50 ± 67 0.102

CFNB = continuous femoral nerve block.Data were presented asmean and standard deviation, and compared with simple t-test.

a Presented as number and percent, and P-values were calculated by chi-square andFisher exact test.

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satisfaction with pain management (reported as 0 = I am not satisfied,1 = I am partially satisfied, and 2 = I am completely satisfied),assessed at the time of catheter (epidural or femoral) removal.

Statistical Analysis

The sample size was calculated based on Davies et al [3] findings ofmedian pain score of 5.5 in the epidural group and amedian of 4 in the(3-in-1) block group, with a standard deviation around 2, at 24 hourspost-surgery. We calculated the sample size with alpha 0.05 and beta0.2, using a two-sample t-test. A sample size of 23 patients in eachgroup deemed to be adequate.

Fig. 2. Mean and standard error. (A) The difference between the pain s


The Shapiro–Wilk test, histograms andQ-Qplotswere used to assessthe normality of each variable distribution. Mean and standarddeviation were used for descriptive analysis of normally distributedvariables, while median and 95% confidence interval for non-normallydistributed. Two-sample t-test was used to compare parametricvariables and Mann–Whitney U test for non-parametric variables.Categorical measurements are presented as numbers and percent, andcompared with chi-square or Fisher exact tests as applicable. Foroutcomes with repeatedly measured (e.g. NRS, morphine consumptionand hemodynamic changes), repeated-measures ANOVA were used toevaluate the difference with respect to time. Significance was acceptedat the 5%. Statistical analysis and figures were performed using SPSS 21software (SPSS, Chicago, IL) and R version 3.0.2 (The R Foundation forStatistical Computing, Vienna, Austria).

Results

A CONSORT trial flow diagram is presented in Fig. 1. Results fromfifty patients, whom underwent unilateral total knee arthroplasty(TKA), were analyzed. There was no statistically significant differencein demographic profile or in clinical characteristics (Table 1).

Primary Outcomes

There were no statistically significant difference between theepidural and CFNB groups in pain scores during the first 72 hourspostoperatively (P = 0.334; ANOVA). Postoperative morphine con-sumption was found not to be statistically different in between thetwo groups (P = 0.096; ANOVA). Fig. 2 illustrates the differencebetween the two groups in postoperative numerical pain scores andmorphine consumption.

cores (NRS) between the two groups. (B) Morphine consumption.



Fig. 3. Hemodynamic profile comparison between the two groups, presented as mean and standard error. (A) Heart rate and (B) mean arterial pressure (MAP).


Secondary Outcomes

There was no difference in the mean arterial pressure or the heartrate in the first 72 hours (P = 0.957, and P = 0.716; ANOVA). Fig. 3,illustrates the mean arterial pressure and heart rate for both groups inthe first 72 hours which were not different.

Postoperative rehabilitation course did not show a statisticallysignificant difference in all aspects that were measured. Fig. 4Aillustrates the similar distance of maximummobilization between theepidural and CFNB patients (P = 0.808; ANOVA), while in bothgroups the patients' mobilization progresses daily in a significantmanner (P b 0.0001). Fig. 4B, also illustrates a very similar range ofknee joint motion between the two groups (P = 0.830; ANOVA), witha significant improvements over days in both groups were occurred(P b 0.0001). Table 2, summarizes different methods of rehabilitationassessment that also shows no statistical difference between the twogroups. No full down cases or patients local anesthetic toxicity wasreported in this cohort

Thirty-two percent (n = 8) of the patients in the epidural groupwerepartially satisfiedwith their painmanagement,while 68% (n = 17)were completely satisfied. On the other hand, 36% (n = 9) of thepatients in the CFNB group were partially satisfied, with 64% (n = 16)completely satisfied. No statistical differences were detected betweenthe two groups.

Discussion

The ideal analgesia for TKA should provide robust pain control,limited side effects, with minimal effect on motor power facilitatingearly postoperative mobilization, balance, and rehabilitation. A clearbenefit of regional analgesia/anesthesia (epidural and peripheralnerve blocks) over general anesthesia and/or systemic analgesia hasbeen demonstrated in reducing postoperative pain, morphine


consumption, and opioid-related adverse effects. Length of stay maybe also reduced and rehabilitation facilitated for patients undergoingregional analgesia/anesthesia for TKA [17].

In theory, peripheral nerve block has the advantage of sparingmotor control in one leg to allow for early mobilization with crutches.However, its equivalence of pain control with neuraxial analgesia iscontroversial. Epidural analgesia has been thought to be the “goldstandard” of pain relief after total knee arthroplasty [18], and somestudies have suggested that it is superior to CFNB for pain control,especially in the early postoperative hours [10,11]. While otherstudies showed superiority of CFNB over epidural [12].

In our study, we found that both techniques were equivalent inpain management and in facilitating rehabilitation course. Indeed,both techniques provided excellent analgesia with minimal system-atic morphine consumption (Fig. 2). In fact, even with using lowanalgesic concentrations [5 ml/hour 0.2% bupivacaine for femoralnerve block and 0.0625% bupivacaine with fentanyl (2 mcg/ml) atrate 5–10 ml/hour] in both groups, to minimize the effect in motorpower and reduce the systemic opioids side effects, the postoperativepain management was adequate and morphine consumption wasminimal. Hemodynamic changes were not concerning and therehabilitation course was excellent. Thus, from our findings wewould conclude that the techniques are equivalent.

The analgesic drug concentration and volume, as well as thefemoral nerve block technique used (e.g. ultrasound versus nervestimulator), seem to determine the variability in the outcomes inthese cases. Barrington et al used bupivacaine 0.2% with medianinfusion rate 9.3 ml/hour for CFNB and ropivacaine 0.2%with fentanyl4 mcg/ml (median infusion rate 7.6 ml/hour) for CEI, they showedequivalent pain scores, range of movement, and rehabilitation in bothgroups [19]. Sundarathiti et al used 0.125% levobupivacaine (8 ml/hour)for CFNB, and found that patients had significantly higher postoperativepain at 6 and 12 hours with higher tramadol consumption in



Fig. 4. Median and 95% CI. (A) Daily patient mobilization at the time of thephysiotherapist visit. (B) Daily assessment of knee joint range of motion (ROM).

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comparison to the CEI (maintained by continuous infusion of 0.125%levobupivacaine with morphine 0.0125 mg/ml at 4 ml/hour) [10]. Inanother cohort, Shanthanna et al did use 0.125% bupivacaine mixedwith 2 mcg/ml fentanyl for both groups, they found that pain scoreswere significantly higher in the femoral group at 6 hours, after whichthere was a declining trend, and scores were essentially similar from

Table 2Secondary Outcomes (Rehabilitation Profile).

Parameter

Epidural groupn = 25

CFNB groupn = 25

P-valueDay 1 Day 2 Day 3 Day 1 Day 2 Day 3

Number of patientsachieved kneejoint movement(N90°)

15 (60) 17 (68) 18 (72) 14 (56) 17 (68) 23 (92) 0.988

Straight leg test

• Dependent 12 (48) 7 (28) 5 (20) 10 (40) 7 (28) 4 (16) 0.998

• Independent 13 (52) 18 (72) 20 (80) 15 (60) 18 (72) 21 (84) 0.999

CFNB = continuous femoral nerve block.Data presented as number and percent (%), and P-values were calculated by chi-squareand Fisher exact test.


24 hours. Common side-effects were more common in the CEI group[11]. Sakai et al used ropivacaine 0.15% into both CEI and CFNB, andfound that patients in the CFNB group attained earlier knee flexion to120°, less pain during rehabilitation, and less need for adjuvantanalgesics [12].

The systemic side effect profile for CEI was higher in most studies.Lorenzini et al reported that 68% of patients had nausea or vomiting,66% had urinary retention, and 58% had pruritus after 24 hours ofepidural infusion [20]. However, Zaric et al found one or more sideeffects were present in 87% of patients in the epidural group whereasonly 35% of patients in the femoral and sciatic block groups wereaffected on the first postoperative day [18]. On the other hand, CFNBhas been found to reduce the incidence of postoperative delirium [21].

The use of ultrasound guidance to place the catheter and theconcentration and amount of anesthetics used seem to affect thepotency and efficacy of the CFNB. Ultrasound-guided CFNB (0.2%bupivacaine infusion at 5 ml/hour, with single shot sciatic nerve blockwith 15 ml of 0.25% bupivacaine) seems to have similar analgesic effectsand rehabilitation course to CEI [0.0625% bupivacaine + fentanyl(2 mcg/ml) at 5–10 ml/hour].

A potential limitation for this study is the fact that preoperativemental health status was not assessed, whichmight play an importantrole in the patient's pain and the results of this study. As such, wecannot rule out a significant effect of the patient's mental health ontheir pain perception.

In conclusion, our study found that both techniques were excellentin terms of postoperative pain score, systemic opioid consumption,and hospital rehabilitation course. The use of ultrasound-guidedcontinuous femoral nerve block for postoperative pain control inunilateral knee arthroplasty can be a good alternative to continuousepidural analgesia.

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