Topical Lidocaine-Prilocaine Cream (Emla) Versus Mepivacaine Infiltration for Reducing Pain During Repair of Mediolateral Episio
AL-AZHAR ASSIUT MEDICAL JOURNAL AAMJ ,VOL 13 , NO 4 , OCTOPER 2015 SUPPL-2
TOPICAL LIDOCAINE-PRILOCAINE CREAM (EMLA) VERSUS MEPIVACAINE INFILTRATION FOR REDUCING PAIN DURING REPAIR OF MEDIOLATERAL EPISIOTOMY AFTER SPONTANEOUS VAGINAL DELIVERY Hossam M Abdelnaby and Ahmed Mahmoud Abdou Obstetrics & Gynecology Department, Faculty of Medicine, Zagazig University ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ ABSTRACT Objective: to compare the efficacy of lidocaine-prilocaine cream (EMLA cream) versus ordinary local infiltration anesthetic mepivacaine in pain relief during repair of mediolateral episiotomy. Patients and methods: This study was conducted during the period from 1 January 2015 to 31 July 2015 in Zagazig University Maternity Hospital, Egypt. It comprised 82 vaginally laboring women. They were randomly allocated into 2 groups; group a (mepivacaine 1% infiltration just before performing the episiotomy) and group B (lidocaine-prilocaine cream applied as a thick layer to perineum approximately one hour before the predictable time of childbirth). Primary outcome measure was pain scores during repair of episiotomy after childbirth. Secondary outcome measures were the need for additional intra-operative anesthetic or post-operative analgesia and patient satisfaction. Results: There was a statistically significant more pain score during the suture of episiotomy in mepivacaine group than in EMLA group regarding the VAS (Visual Analog Scale) of patients and doctors. Results showed that the patient overall satisfaction was more in EMLA group than in mepivacaine group. Results showed that the request of additional intra-operative anesthetic or post-operative was more in mepivacaine group than in the patient of EMLA group. Conclusion: Lidocaine- prilocaine (EMLA) cream is more effective in pain relief during perineal suturing, easier to use and has higher patient satisfaction than ordinary local infiltration anesthetic mepivacaine.
INTRODUCTION absorption. Previous studies on topical anesthetics Incising the perineum during the second stage of for perineal pain relief had produced contradictory labor to widen vaginal opening during labor is results [7, 8]; they concentrated on pain during the called episiotomy. It is considered the whole second stage of labor [9] or during commonest obstetric maneuver. [1] puerperium but they did not focus on pain during Episiotomy has many benefits including repair of episiotomy [8, 10, 11]. reduction of incidence of perineal lacerations Lidocaine-prilocaine (EMLA) cream is a [2]. But, it has many drawbacks such as pain. topically applied anesthetic which is widely The worst pain could be felt in the first day used for dermatological, pediatric, gynecologic which may be sever enough to cumbersome and reconstructive minor surgical procedures. puerperium [3]. Many ways have been used to EMLA stands for eutectic mixture of local overcome this problem such as Epidural anesthetics (lidocaine 2.5% and prilocaine anesthesia. Epidural anesthesia is frequently 2.5%). It has rapid onset ranging between 5 and used for pain relieve during labor.Under 10 minutes and reaches effective action after 15 epidural anesthesia, episiotomy can be done to 20 minutes as it has rapid absorption through without need of additional anesthesia[4]. genital mucosa. Although it needs longer After resolution of epidural anesthesia,severe duration to reach effective anesthesia when pain is usually felt. Thus, injection of local applied on intact skin, so it should be applied at anesthetic during episiotomy could be least one hour before procedure [12]. considered. The commonest used method for AIM OF STUDY pain relief during repair of episiotomy is The aim of this study is to evaluate the role of perineal infiltration with local anesthetics [5]. EMLA cream (lidocaine –prilocaine cream)in Up till now, local anesthetic infiltration is reducing pain during repair of episiotomy after considered the basic method for pain relief childbirth in comparison to ordinary infiltration during minor surgical procedures. Other forms anesthetic (mepivacaine). of local anesthetics; ointments, gels and sprays, PATIENTS AND METHODS have appeared as an option in many minor Setting: interventions [5, 6]. This study was done during the period from 1 Topical forms of local anesthetics have many January 2015 to 31July 2015 in Zagazig advantages over local infiltrative anesthetics University Maternity Hospital, Egypt. including; painless and easy application, no Sample size: edema at wound edges and limited systemic
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Reducing pain during repair of episiotomy after The study comprised 82 vaginally laboring childbirth, interval based on: women: . C.I. 95% Group A (41 cases) had undergone pain control . Power 80% during suturing of episiotomy after delivery by Ratio of sample size 1:1 (mepivacaine infiltration); 10ml of 1% Efficacy of lidocaine-prilocaine cream was 83% mepivacaine solutions was injected slowly along . Risk ratio 1.58 the line episiotomy with many aspirations to So, sample size was 82 cases; divided into 2 prevent intravascular injection before performing groups. the episiotomy. Randomization: Group B (41 cases) had undergone pain control After identifying the patient fulfilling the during suturing of episiotomy after delivery with criteria of the study participants were divided lidocaine-prilocaine cream. 5 grams of lidocaine- into two groups by simple randomization with a prilocaine cream applied as a thick layer to the 1:1 allocation ratio. The allocation group was intact surface of perineum at 8-9cm of cervical written on cards inside sequentially numbered, dilatation during labor approximately one hour opaque and sealed envelopes. The envelopes before the expected time of birth and covered with were opened at the time of allocation after an occlusive dressingto enhanceabsorption baseline assessment of all participants. Closed through skin. At the time of crowning, the envelope chosen by third parties. occlusive dressing and any remnants of the cream (1) Group A “mepivacaine group” (41 cases): were removed to prevent fetal eye irritation and Women of this group had their episiotomies episiotomy was done. repaired with local injection of (10 ml of 1% Episiotomy wasdone at time of peak of uterine mepivacaine) for pain relief. contraction as mediolateral one. It was repaired (2) Group B “EMLA group” (41 cases): women in layers with a continuous, non-locking suture in this group had their episiotomies repaired to close vaginal mucosa, perineal muscles, after EMLA cream application for pain control. subcutaneous tissue and skin. Primary outcome measures: After repair of episiotomy, the severity of pain Pain scores during perineal suturing after graded by both patient and doctor; childbirth. Each patient was asked to mark the pain severity Secondary outcomes: during repair of episiotomy on a 10 cm Visual The number of patients who needed additional Analog Scale (VAS). The far left (0 cm) was intra-operative anesthetic or post-operative labeled „pain is absent‟ and the far right (10 cm) analgesia and patient satisfaction. was labeled as „severe agonizing pain. The patient Subjects: was asked to make a vertical mark on this line that Pregnant women aged ≥ 18 years with best indicated her pain on VAS. The numeric uncomplicated, singleton gestation, vertex score was derived by measuring the distance in presentation, delivery at 37-41 weeks and millimeters from far left of VAS line to mark episiotomy performed during vaginal delivery made by patient. It was predefined that patients were included in the study. with VAS ≤ 30 mm were categorized as having Epidural analgesia request, instrumental mild pain (1-3); those with scores of ≥ 70 mm as delivery, patients with perineal tear, para- having severe pain (7-10) and those between 31 uretheral tears, lateral vaginal tears, previous mm to 69 mm as moderate pain (4-6). repaired complete perineal tear, local perineal The doctor determined the degree of pain felt by infection, history of adverse reaction to local women while repairing the perineum depending anesthetic, altered mental status, using of on their facial expressions and then selected the systemic opioids or pudendal nerve block, corresponding expressions from the faces pain patients with known hepatic disorders and rating scale which is one of the diagnostic tools glucose-6 phosphate dehydrogenase (G6PD) that is used to assist the severity and quality of deficiency, were excluded from the study. If the pain experienced by patients. Then doctor began time of birth exceed one hour after application analyzing facial expressions and gave them a of Lidocaine-prilocaine cream, patient was grade on a prescribed scale (pain rating scale). excluded from the study. This grading scale indicates that face 0, that goes The protocol of this study was approved by our with a grade (0-1) of numerical rating scale, institutional review boardof Faculty of Medicine, indicates no pain, face 1 that goes with grade (2- Zagazig University. Written & fully informed 3) of numerical rating scale, indicates mild pain, consents were obtained from all women faces2&3 that goes with grade (4-6) of numerical participating in the study. rating scale, indicate moderate pain, faces 4&5,
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that goes with a grade (7-10) of numerical rating relief during repair of episiotomy reported lower scale, indicate sever pain. pain scores during perineal repair compared Need of additional anesthetics during repair of with women who received mepivacaine episiotomy was recorded and also need of infiltration for pain relief. Mean visual analogue additional postoperative analgesics was also scale (VAS) was statistically significant lower recorded. Finally, overall satisfaction was in EMLA group than in mepivacaine infiltration assessed by asking women to express their group as shown in table (2). opinion on these anesthetic methods during Woman who received topical application of repair of episiotomy with “yes” or “no” EMLA cream as a local anesthesia for pain answers. relief during repair of episiotomy, their doctor Statistical analysis reported that they felt by pain scores during Collected data were analyzed using Microsoft perineal repair lower than that felt by women Excel software and were imported to Statistical who received mepivacaine infiltration for pain Package for Social Sciences software (SPSS relief. Mean visual analogue scale (VAS) was version 20.0) for their analysis. Data were statistically significant lower in EMLA group analyzed using Chi-square test and t test. The than in mepivacaine infiltration group as shown results were considered significant when P in table (3). value was <0.05 and were considered highly Patients who had received EMLA cream as a significant if P value was<0.001. topical anesthetic were more satisfied than the RESULTS patients who had received mepivacaine Eighty two patients were selected from Zagazig infiltration as a local infiltrative anesthetic University Maternity Hospital. They were all (table 4). primigravida with singleton gestation. They were Request of additional intra-operative anesthetic randomly allocated to relief pain during perineal in patients who had received EMLA cream as a suturing of episiotomy after childbirth either by topical anesthetic was lower than that in patients mepivacaine infiltration or lidocaine-prilocaine who had received mepivacaine infiltration as a cream. local infiltrative anesthetic. Also, request of There was no statistically significant difference additional post-operative analgesia in patients between both groups concerning; maternal age, who had received EMLA cream as a topical body mass index, gestational age, neonatal anesthetic was lower than that in the patients weight and neonatal head circumference (table who had received mepivacaine infiltration as a 1). local infiltrative anesthetic (table 5). Women who received topical application of EMLA cream as a local anesthesia for pain Table (1): Maternal age, body mass index, gestational age, neonatal weight and neonatal head circumference. Group A Group B t/X2 P-value No = 41 No = 41 Age Range 20 – 30 20 – 32 1.757 0.083 Mean ± S.D. 26.12 ± 2.87 24.93± 3.28 BMI Range 23.8 – 33.0 24.6 – 30.0 1.609 0.112 Mean ± S.D. 27.37±2.08 27.09 ±1.52 Gestational age Range 37 – 40.2 37 – 41 1.603 0.113 Mean±S.D. 39.37± 0.70 39.08± 0.90 Neonatal weight Range 2750 – 3350 2800 – 3600 -1.117 0.267 Mean ± S.D. 3030.73±186.85 3080.56±216.08 Head circumference Range 33 – 39 31 – 39 -1.353 0.180 Mean ± S.D. 35.63±2.21 36.24±1.85 Table (2): Comparison between the two studied groups regarding visual analogue scale according to patients. Group A Group B Visual analogue scale of patient t/ X2 P-value No. % No. % Mild (1-3) 9 22.0% 20 48.8% Moderate (4-6) 16 39.0% 15 36.6% 8.750 0.013 Severe (7-10) 16 39.0% 6 14.6% Mean± S.D. 6.17 ± 2.59 4.39 ± 2.32 3.279 0.002
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Table (3): Comparison between the two studied groups regarding faces pain rating scale (VAS) according to doctors. Group A Group B Faces pain rating scale of doctor T/X2 P-value No. % No. % Mild (1-3) 12 29.3% 22 53.66% Moderate (4-6) 16 39.0% 15 36.59% 7.738 0.020 Severe (7-10) 13 31.7% 4 9.76% Mean± S.D. 5.61 ± 2.54 3.93 ± 2.13 3.254 0.002 Table (4): Comparison between the two studied groups regarding patients’ satisfaction. Group A Group B Patients satisfaction No = 41 No = 41 X2 P No. % No. % Yes 19 46.34% 32 78.05% 8.765 0.003 No 22 53.66% 9 21.95% Table (5): Comparison between the two studied groups regarding the request of additional intra-operative anesthetic or post-operative analgesia. Group A Group B No = 41 No = 41 X2 P No. % No. % Intra-operative No 16 39.0% 30 73.2% 9.705 0.002 Yes 25 61.0% 11 26.8% Post-operative No 14 34.1% 29 70.7% 11.002 0.001 Yes 27 65.9% 12 29.3% Our findings in contrast to with those of DISCUSSION Minassian et al. in 2002 [10] who reported that Labor is a painful condition, considered to be there were no statistically significant difference one of the most intense and stressful experience, detected between topical application of 5% especially for nulliparous women [13]. lidocaine ointment and placebo in reliving The commonest used method for pain relief perineal pain after repair of episiotomy or perineal during repair of episiotomy is perineal lacerations.They assessed pain relief by; amount infiltration with local anesthetics. Up till now, of ointment used, total number of pain pills used local anesthetic infiltration is considered the and pain questionnaire.They concluded that, basic method for pain relief during minor application of topical 5% lidocaine ointment surgical procedures. Other forms of local was not effective for pain relief after repair of anesthetics; ointments, gels and sprays, have episiotomy or perineal laceration[10]. appeared as an option in many minor Our findings in contrast to those of Sanders et interventions [5]. Lidocaine-prilocaine (EMLA) al. in 2006 [9] who published their randomized cream is a topically applied anesthetic which is study on 185 patients during vaginal delivery to widely used for dermatological, pediatric, evaluate efficacy of lidocaine spray in perineal gynecologic and reconstructive minor surgical pain relief during spontaneous vaginal delivery. procedures. EMLA stands for eutectic mixture The number of patients in lidocaine spray group of local anesthetics (lidocaine 2.5% and was 93 patients and placebo spray group was 92 prilocaine 2.5%) [12]. patients. The primary outcome measure was As regard pain score during repair of episiotomy pain during delivery by using a 10 cm VAS. that was assessed by a 10-cm VAS, our findings They concluded that, lidocaine spray did not agree with those of Franchi et al “2009” who reduce pain during spontaneous vaginal delivery published their research on 61primigravida that [9]. were randomly allocated to either local As regard pain score and required additional infiltration of 20 ml of 1% “mepivacaine” (n= analgesia during repair of episiotomy that was 30) or topical application of “EMLA” cream (n= assessed by a 10 cm VAS, our findings were in 31) and reported that the application of EMLA contrast to Duhan and Nadal in 2013 [15] while cream to the perineum yielded lower pain scores as regard patients satisfaction our finding agree as compared to mepivacaine infiltration. They with them.They studied the effect of EMLA also found that patient satisfaction was cream versus lignocaine infiltration anesthesia significantly higher among patients used EMLA for pain relief during perineal suturing. Their cream for pain relief. But, they found no study included 100 healthy primigravida with significant difference between both groups singleton gestations, that were randomly divided regarding requirement of additional anesthesia into two groups; either receive EMLA cream or [14]. lignocaine infiltration. They found that there was no significant difference between both
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groups regarding pain score which was assessed 10. Minassian VA, Jazayeri A, Prien SD, by VAS, also they reported no significant Timmons RL, Stumbo K. Randomized Trial difference between both groups regarding of Lidocaine Ointment Versus Placebo for requirement of additional anesthesia. But, they The Treatment of Postpartum Perineal Pain. found that patient satisfaction was significantly Obstet Gynecol 2002; 100(6):1239-43. higher among patients received EMLA cream 11. Seckin B, Avsar F, Parlakygit EE, Aksakal for pain relief [15]. O. Effects of indomethacin suppository and lidocaine pomade for the relief of post- CONCLUSION episiotomy pain. Int J Gynaecol Obstet Lidocaine- prilocaine (EMLA) cream is more 2002;78: 159-61. effective in pain relief during perineal suturing, 12. Friedman PM, Mafong EA, Friedman ES, easier to use and has higher patient satisfaction Geronemus RG. Topical anesthetics update: than ordinary local infiltration anesthetic EMLA and beyond. Dermatologic surgery mepivacaine. 2001; 27(12): 1019-26. 13. Sheiner E, Shoham-Vardi I, Sheiner EK, et REFERENCES al. A comparison between the effectiveness 1. National Collaborating Centre for Women‟s of epidural analgesia and parenteral and Children‟s Health (UK). Intrapartum pethidine during labor. Arch Gynecol Obstet care: care of healthy women and their babies 2000; 263: 95–8. during childbirth. NICE Clinical Guidelines 14. Franchi M, Cromi A, Scarperi S, et al. 2007; 55: 168–70. Comparison between lidocaine-prilocaine 2. Cleary-Goldman J and Robinson JN. The role cream (EMLA) and mepivacaine infiltration of episiotomy in current obstetric practice. for pain relief during perineal repair after Semin Perinatol 2003; 27:3–12. childbirth: a randomized trial. Am J Obst 3. Macarthur AJ and Macarthur C. Incidence, Gynecol 2009; 201(2): 186.e1-5. severity, and determinants of perineal pain 15. Duhan N and Nandal R. Topical Lidocaine- after vaginal delivery: a prospective cohort Prilocaine Cream Versus Lignocaine study. Am J Obstet Gynecol 2004; Infiltration For Episiotomy Repair: A 191:1199–204. Randomized Clinical Trial. Journal of 4. Issaoui Y, Bruye`re R, Mustapha H, Bry D, Clinical Research & Governance DrissiKamili N, Miller CA. Randomized 2013; 2(2):43-6. controlled trial of pudendal nerve block for
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