Comparison Between Lidocaine Prilocaine Cream and Lidocaine Injection on Pain Control During Episiotomy.

NCT05891132 | Completed DMC

• 1 other identifier: MD-12-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Episiotomy Wound

Keywords

Episiotomy; Anesthesia during labor; Injectable anesthetic; Topical anesthetic; Postpartum pain; Postpartum infection; Dyspareunia

Outcome Measures

Primary Outcomes (1)

• Effect of the Intervention on pain score during the repair of episiotomy

  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.

  1 year

Secondary Outcomes (2)

• Effect of the Intervention on pain score during 6 weeks postpartum and dyspareunia after 6 weeks post partum

  1 year

• Effect of the Intervention on perineal infection during 6 weeks postpartum

  1 year

Study Arms (2)

Group I comprised 30 women who will receive 10 ml of lidocaine 2%

ACTIVE COMPARATOR

10 ml of lidocaine 2% for perineal infiltration at the time of crowning

Drug: 10 ml of lidocaine 2%

Group II will have lidocaine prilocaine cream 15gm application on the perineum

ACTIVE COMPARATOR

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

Drug: lidocaine prilocaine cream 15gm

Interventions

10 ml of lidocaine 2% DRUG

10 ml of lidocaine 2% for perineal infiltration at the time of crowning

Also known as: Local ( injectable ) anesthetic

Group I comprised 30 women who will receive 10 ml of lidocaine 2%

lidocaine prilocaine cream 15gm DRUG

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.

Also known as: EMLA cream

Group II will have lidocaine prilocaine cream 15gm application on the perineum

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women candidate for VD ( ASA Ⅱ )
• Primigravida
• Pregnant more than 37 weeks (Term pregnancy).
• Singleton fetus.
• Cephalic presentation.
• In first stage of labor.

You may not qualify if:

• More than or equal 1 previous CS and VBAC.
• Multiparous women.
• Pregnant less than 37 weeks
• Twin pregnancy.
• Not in active labor
• allergy to lignocaine
• altered mental status
• request for epidural analgesia
• Hepatic impairment.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (14)

• 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: 18031878 BACKGROUND

• 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: 21236531 BACKGROUND

• 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: 30122981 BACKGROUND

• Field T. Pregnancy and labor alternative therapy research. Altern Ther Health Med. 2008 Sep-Oct;14(5):28-34.

  PMID: 18780582 BACKGROUND

• 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: 3048583 BACKGROUND

• 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: 21386951 BACKGROUND

• 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: 27385970 BACKGROUND

• 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: 20623233 BACKGROUND

• 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: 15878430 BACKGROUND

• 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: 29235159 BACKGROUND

• 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: 19920722 BACKGROUND

• 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: 28107576 BACKGROUND

• Walker SM. Neonatal pain. Paediatr Anaesth. 2014 Jan;24(1):39-48. doi: 10.1111/pan.12293. Epub 2013 Nov 13.

  PMID: 24330444 BACKGROUND

• 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.

  PMID: 11889416 BACKGROUND

Related Links

• An investigation into the effect of alpha ointment (fundermol) on perineal pain relief following episiotomy in Nulliparous Women
• Comparative study of eutectic mixture of lignocaine-prilocaine (EMLA) cream and lignocaine infiltration for pain relief during episiotomy and its repair
• Who invented the episiotomy? On the history of the episiotomy
• 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).
• Kumar, M., Chawla, R., \& Goyal, M. (2015). Topical anesthesia. Journal of Anaesthesiology Clinical Pharmacology, 31(4), 450
• 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).
• Nirmala D, Ritu NA: ndalTopical lidocaine- prilocaine cream versus lignocaine infiltration for episiotomy repair: A randomized clinical trial. (2013). Journal of Clinical Research \& Governance.

MeSH Terms

Conditions

Dyspareunia

Interventions

Injections; Anesthetics; Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Ahmed S Alharty, MD

  Cairo U

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Group I comprised 30 women who will receive 10 ml of lidocaine 2% for perineal infiltration at the time of crowning while 30 women. 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.

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: September 1, 2022
• Primary Completion: July 19, 2024
• Study Completion: September 1, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)