Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-29 @ 1:16 PM
Study NCT ID:
NCT05891132
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2023-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Lidocaine Prilocaine Cream and Lidocaine Injection on Pain Control During Episiotomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004414', 'term': 'Dyspareunia'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D000077442', 'term': 'Lidocaine, Prilocaine Drug Combination'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011318', 'term': 'Prilocaine'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'This will be a randomized controlled trial, randomization will be achieved by the following: the allocation treatment will be written on cards that will be sealed in sequentially numbered envelopes. The envelopes will be opened at the time of allocation after the enrolled participants will complete all baseline assessments. Group I comprised 30 women who will receive 10 ml of lidocaine 2% for perineal infiltration at the time of crowning while 30 women of Group II will have lidocaine prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then an additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group I comprised 30 women who will receive 10 ml of lidocaine 2% for perineal infiltration at the time of crowning while 30 women.\n\nGroup II will have lidocaine prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-06-05', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of the Intervention on pain score during the repair of episiotomy', 'timeFrame': '1 year', 'description': 'Efficacy of lidocaine-pridocaine cream in pain control for episiotomy incision and repair assessed by Visual Analogue Score VAS during episiotomy incision and repair where the minimum value is equal to zero which means no pain at all and the maximum value is equal to 10 and this means the worst pain ever.'}], 'secondaryOutcomes': [{'measure': 'Effect of the Intervention on pain score during 6 weeks postpartum and dyspareunia after 6 weeks post partum', 'timeFrame': '1 year', 'description': 'Pain score in the first week post-partum and 6 weeks post-partum also dysparunia after 6 weeks of delivery will be assessed by Customer Satisfaction Score or CSAT score, where the minimum value is very unsatisfied and associated with the highest degree of pain and the maximum value is very satisfied and this associated with the lowest degree of pain in 1 week and 6 weeks post patum'}, {'measure': 'Effect of the Intervention on perineal infection during 6 weeks postpartum', 'timeFrame': '1 year', 'description': 'Detection of the infection rates 6 weeks post-partum as this is the period of perpurium when puerperal sepsis may develops.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Episiotomy', 'Anesthesia during labor', 'Injectable anesthetic', 'Topical anesthetic', 'Postpartum pain', 'Postpartum infection', 'Dyspareunia'], 'conditions': ['Episiotomy Wound']}, 'referencesModule': {'references': [{'pmid': '18031878', 'type': 'BACKGROUND', 'citation': "Dahlen HG, Homer CS, Cooke M, Upton AM, Nunn RA, Brodrick BS. 'Soothing the ring of fire': Australian women's and midwives' experiences of using perineal warm packs in the second stage of labour. Midwifery. 2009 Apr;25(2):e39-48. doi: 10.1016/j.midw.2007.08.002. Epub 2007 Nov 26."}, {'pmid': '21236531', 'type': 'BACKGROUND', 'citation': 'East CE, Sherburn M, Nagle C, Said J, Forster D. Perineal pain following childbirth: prevalence, effects on postnatal recovery and analgesia usage. Midwifery. 2012 Feb;28(1):93-7. doi: 10.1016/j.midw.2010.11.009. Epub 2011 Jan 13.'}, {'pmid': '30122981', 'type': 'BACKGROUND', 'citation': 'El-Boghdadly K, Pawa A, Chin KJ. Local anesthetic systemic toxicity: current perspectives. Local Reg Anesth. 2018 Aug 8;11:35-44. doi: 10.2147/LRA.S154512. eCollection 2018.'}, {'pmid': '18780582', 'type': 'BACKGROUND', 'citation': 'Field T. Pregnancy and labor alternative therapy research. Altern Ther Health Med. 2008 Sep-Oct;14(5):28-34.'}, {'pmid': '3048583', 'type': 'BACKGROUND', 'citation': 'Simionescu R. [Stress reaction and anesthesia. The role of morphine agonists and antagonists]. Cah Anesthesiol. 1988 Jun-Jul;36(4):289-301. No abstract available. French.'}, {'pmid': '21386951', 'type': 'BACKGROUND', 'citation': 'Jorge LL, Feres CC, Teles VE. Topical preparations for pain relief: efficacy and patient adherence. J Pain Res. 2010 Dec 20;4:11-24. doi: 10.2147/JPR.S9492.'}, {'pmid': '27385970', 'type': 'BACKGROUND', 'citation': 'Kargar R, Aghazadeh-Nainie A, Khoddami-Vishteh HR. Comparison of the Effects of Lidocaine Prilocaine Cream (EMLA) and Lidocaine Injection on Reduction of Perineal Pain During Perineum Repair in Normal Vaginal Delivery. J Family Reprod Health. 2016 Mar;10(1):21-6.'}, {'pmid': '20623233', 'type': 'BACKGROUND', 'citation': 'Lullmann B, Leonhardt J, Metzelder M, Hoy L, Gerr H, Linderkamp C, Klein C, Grigull L. Pain reduction in children during port-a-cath catheter puncture using local anaesthesia with EMLA. Eur J Pediatr. 2010 Dec;169(12):1465-9. doi: 10.1007/s00431-010-1244-1. Epub 2010 Jul 10.'}, {'pmid': '15878430', 'type': 'BACKGROUND', 'citation': 'Sanders J, Peters TJ, Campbell R. Techniques to reduce perineal pain during spontaneous vaginal delivery and perineal suturing: a UK survey of midwifery practice. Midwifery. 2005 Jun;21(2):154-60. doi: 10.1016/j.midw.2004.12.003. Epub 2005 Mar 27.'}, {'pmid': '29235159', 'type': 'BACKGROUND', 'citation': 'Shahrahmani H, Kariman N, Jannesari S, Rafieian-Kopaei M, Mirzaei M, Ghalandari S, Shahrahmani N, Mardani G. The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized, double-blind, placebo-controlled clinical trial. Phytother Res. 2018 Mar;32(3):522-530. doi: 10.1002/ptr.5999. Epub 2017 Dec 13.'}, {'pmid': '19920722', 'type': 'BACKGROUND', 'citation': 'Shavit I, Hadash A, Knaani-Levinz H, Shachor-Meyouhas Y, Kassis I. Lidocaine-based topical anesthetic with disinfectant (LidoDin) versus EMLA for venipuncture: a randomized controlled trial. Clin J Pain. 2009 Oct;25(8):711-4. doi: 10.1097/AJP.0b013e3181a689ec.'}, {'pmid': '28107576', 'type': 'BACKGROUND', 'citation': 'Greveling K, Prens EP, Liu L, van Doorn MBA. Non-invasive anaesthetic methods for dermatological laser procedures: a systematic review. J Eur Acad Dermatol Venereol. 2017 Jul;31(7):1096-1110. doi: 10.1111/jdv.14130. Epub 2017 Feb 8.'}, {'pmid': '24330444', 'type': 'BACKGROUND', 'citation': 'Walker SM. Neonatal pain. Paediatr Anaesth. 2014 Jan;24(1):39-48. doi: 10.1111/pan.12293. Epub 2013 Nov 13.'}, {'pmid': '11889416', 'type': 'BACKGROUND', 'citation': 'Zilbert A. Topical anesthesia for minor gynecological procedures: a review. Obstet Gynecol Surv. 2002 Mar;57(3):171-8. doi: 10.1097/00006254-200203000-00022.'}], 'seeAlsoLinks': [{'url': 'https://jmrh.mums.ac.ir/article_7979.htmlhttp://jmrh.mums.ac.ir/article_9975.html', 'label': 'An investigation into the effect of alpha ointment (fundermol) on perineal pain relief following episiotomy in Nulliparous Women'}, {'url': 'http://articles.theindianpractitioner.com/index.php/tip/article/view/158', 'label': 'Comparative study of eutectic mixture of lignocaine-prilocaine (EMLA) cream and lignocaine infiltration for pain relief during episiotomy and its repair'}, {'url': 'https://europepmc.org/article/med/8503239', 'label': 'Who invented the episiotomy? On the history of the episiotomy'}, {'url': 'https://doi.org/10.1016/j.ajog.2009.04.023', 'label': 'Comparison between lidocaine-prilocaine cream (EMLA) and Mepivacaine infiltration for pain relief during perineal repair after childbirth: A randomized trial. American Journal of Obstetrics and Gynecology, 201(2).'}, {'url': 'https://doi.org/10.4103/0970-9185.169049', 'label': 'Kumar, M., Chawla, R., \\& Goyal, M. (2015). Topical anesthesia. Journal of Anaesthesiology Clinical Pharmacology, 31(4), 450'}, {'url': 'https://doi.org/10.1016/j.ajog.2004.02.064', 'label': 'Macarthur, A. J. \\& Macarthur, C. Incidence, severity, and determinants of perineal pain after vaginal delivery: A prospective cohort study. American Journal of Obstetrics and Gynecology 191, 1199-1204 (2004).'}, {'url': 'https://scholar.archive.org/work/fatlevhx3jbm7j6qoe63wutrey/access/wayback/http://index.sciencepub.se/ojs/index.php/JCRG/article/download/59/27', 'label': 'Nirmala D, Ritu NA: ndalTopical lidocaine- prilocaine cream versus lignocaine infiltration for episiotomy repair: A randomized clinical trial. (2013). Journal of Clinical Research \\& Governance.'}]}, 'descriptionModule': {'briefSummary': 'The present study aims to compare the effects of lidocaine-prilocaine cream and lidocaine injection on the reduction of pain while doing and repairing episiotomy, controlling the pain in the post-partum period, and reduction the risk of infection in 6 weeks post partum and dyspareunia after 6 weeks post-partum.', 'detailedDescription': "Population of study \\& disease condition:\n\nThe study will be conducted on 60 patients that will be admitted to the labor ward in the Department of Obstetrics \\& Gynecology of a tertiary care center of Cairo University from Jan/2023 to Jan/2024 on. Primigravida women with singleton live pregnancy with cephalic presentation in the first stage of labor will be included in the study after approval by the Institutional Ethical Committee and obtaining an informed consent. Those with known allergy to lignocaine, altered mental status, request for epidural analgesia and hepatic disorders will be excluded from the study. The enrolled women will be divided into two groups by simple randomization with a 1:1 allocation ratio.\n\nThe following will be done to all participants:\n\n* Informed written consent: after discussing the nature of the study as well as the expected value, outcome, and possible adverse effects.\n* Full medical history: including full obstetric history and current pregnancy history (entailing the 1st day of LMP).\n* Thorough Clinical Examination: general (vital signs) and full obstetric examination.\n* Obstetric ultrasonography: to confirm gestational age and the eligibility of the current pregnancy to participate in the study.\n\nThis will be a randomized controlled trial, randomization will be achieved by the following: the allocation treatment will be written on cards that will be sealed in sequentially numbered envelopes. The envelopes will be opened at the time of allocation after the enrolled participants will complete all baseline assessments. Group I comprised 30 women who will receive 10 ml of lidocaine 2% for perineal infiltration at the time of crowning while 30 women of Group II will have lidocaine prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum. Lidocaine prilocaine cream, an eutectic mixture, is composed of Lidocaine-25 mg, Prilocaine-25 mg, Arlactone 289 -19 mg, Carbopol-10 mg, Sodium hydroxide to make a pH of 9.6 mg and purified water to produce l gram.\n\nFifteen grams of this cream will be applied as a thick layer (about 2 g/ 10 cm2 area) to the intact surface of the perineum and will be covered with an occlusive dressing (Kumar et al., 2015).\n\nIn previous study done by Nirmala et al., 2013 The mean pain scores in the study were comparable for both groups, in our study we will increase the dose and the intervals of the applied cream and we will write down the results regarding pain score and side effects.\n\nAt the time of crowning, the occlusive dressing and any residue of the cream will be removed and episiotomy will be done. The request for additional anesthetic agent (10 ml of 2% lidocaine solution for both groups) will be honored and recorded for both groups. And if the patient require additional analgesia during episiotomy (VAS more than 3) we will give additional anesthetic agent (10 ml of 2% lidocaine solution. After the repair of episiotomy, each patient will be asked to grade the severity of pain during perineal repair on a Visual Analog Scale (VAS). The far left will be labeled 'No pain' and the far right will be labelled as 'worst pain possible'. The subject will be asked to make a vertical mark on this line reflecting the severity of the pain.\n\nThe patients are followed 6 weeks post-partum at the OPC or by telephone call to check the pain score by using CAST score (Very satisfied - satisfied - not satisfied - dissatisfied).\n\nPost-operative analgesics will include Paracetamol mainly and adjuvant NSAIDs as mentioned in the step ladder pain management by the WHO.\n\nIf any further analgesia needed we will use Pethidine as a rescue analgesic as it is safe after delivery but we will prescribe anti emetic with pethidine as it will induce nausea and vomiting.\n\nPain score during episiotomy repair will be the primary outcome of the study. Secondary outcome measures will include pain score in the first six weeks post-partum, dyspareunia after 6 weeks post-partum ( return to sexual life ) and reduction of the rate of wound infection.\n\nStudy location:\n\nKasr Al Ainy - Causality department (Department 10).\n\nwhat does research involve? Human participants\n\nType of consent of study participants:\n\nWritten consent\n\nConfidentiality of data:\n\n\\- All study-related information will be stored at the study site.\n\nType of the study:\n\n\\- Randomized Control Trial (RCT)"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant women candidate for VD ( ASA Ⅱ )\n2. Primigravida\n3. Pregnant more than 37 weeks (Term pregnancy).\n4. Singleton fetus.\n5. Cephalic presentation.\n6. In first stage of labor.\n\nExclusion Criteria:\n\n1. More than or equal 1 previous CS and VBAC.\n2. Multiparous women.\n3. Pregnant less than 37 weeks\n4. Twin pregnancy.\n5. Not in active labor\n6. allergy to lignocaine\n7. altered mental status\n8. request for epidural analgesia\n9. Hepatic impairment.'}, 'identificationModule': {'nctId': 'NCT05891132', 'briefTitle': 'Comparison Between Lidocaine Prilocaine Cream and Lidocaine Injection on Pain Control During Episiotomy.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparison Between the Effects of Lidocaine Prilocaine Cream and Lidocaine Injection on Reduction of Perineal Pain During Episiotomy and Perineum Repair in Vaginal Delivery: Randomized Control Trial', 'orgStudyIdInfo': {'id': 'MD-12-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I comprised 30 women who will receive 10 ml of lidocaine 2%', 'description': '10 ml of lidocaine 2% for perineal infiltration at the time of crowning', 'interventionNames': ['Drug: 10 ml of lidocaine 2%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II will have lidocaine prilocaine cream 15gm application on the perineum', 'description': 'lidocaine-prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then an additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum', 'interventionNames': ['Drug: lidocaine prilocaine cream 15gm']}], 'interventions': [{'name': '10 ml of lidocaine 2%', 'type': 'DRUG', 'otherNames': ['Local ( injectable ) anesthetic'], 'description': '10 ml of lidocaine 2% for perineal infiltration at the time of crowning', 'armGroupLabels': ['Group I comprised 30 women who will receive 10 ml of lidocaine 2%']}, {'name': 'lidocaine prilocaine cream 15gm', 'type': 'DRUG', 'otherNames': ['EMLA cream'], 'description': 'Lidocaine prilocaine cream, an eutectic mixture, is composed of Lidocaine-25 mg, Prilocaine-25 mg, Arlactone 289 -19 mg, Carbopol-10 mg, Sodium hydroxide to make a pH of 9.6 mg and purified water to produce l gram.', 'armGroupLabels': ['Group II will have lidocaine prilocaine cream 15gm application on the perineum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed S Alharty, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo U'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not for IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Ahmed ElHarty', 'investigatorAffiliation': 'Cairo University'}}}}