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 151 | P a g e Hossam M Abdelnaby and Ahmed Mahmoud Abdou AAMJ ,VOL 13 , NO 4 , OCTOPER 2015 SUPPL-2 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, 152 | P a g e AL-AZHAR ASSIUT
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