The Effect of Lidocaine - Prilocaine Cream (EMLA) Versus Mepivacaine Infiltration on Pain Relief During And After Mediolateral Episiotomies

NCT03264586 | Unknown Phase 4 DMC

• 1 other identifier: 9
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Included women were divided randomly into two groups: Group A: (n=100): women were subjected to application of EMLA® cream "Lidocaine-prilocaine cream (EMLAcream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)"for pain relief during episiotomy repair. Group B: (n=100): women were subjected to application of local injection of 10 ml of 1% mepivacaine for pain relief during episiotomy repair.

Conditions

Episiotomy Pain

Outcome Measures

Primary Outcomes (1)

• pain

  The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale

  24 hours after delivery

Study Arms (2)

Lidocaine-prilocaine cream

ACTIVE COMPARATOR

Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate pemetration thrug stratum corneum * EMLA cream was applied, 1 hour before the expected time of birth. * With the assistance at birth, the residue of cream was removed to prevent contact with the fetus, because sodium hydroxide, which is a component of the cream, can cause fetal eye irritation. * No additional anesthetic was applied if episiotomy was necessary. * Before commancement of perineal repair any residual cream was wiped off.

Drug: Lidocaine-prilocaine cream; Procedure: mediolateral episiotomy

mepivacaine infiltration group

ACTIVE COMPARATOR

* In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection. * In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution. * The suture procedure was delayed 10 minutes after the injection of the aneathetic

Drug: mepivacaine infiltration group; Procedure: mediolateral episiotomy

Interventions

Lidocaine-prilocaine cream DRUG

5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate penetration \- EMLA cream was applied, 1 hour before the expected time of birth.

Also known as: EMLA cream

Lidocaine-prilocaine cream

mepivacaine infiltration group DRUG

10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection. * In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution. * The suture procedure was delayed 10 minutes after the injection of the aneathetic

Also known as: 1% mepivacaine

mepivacaine infiltration group

mediolateral episiotomy PROCEDURE

Episiotomy repair a loose, continous, non locking suture to close the vaginal mucosa and the muscular layer of the perineum using vicryl Number zero (0). * At the end of the vaginal mucosal repair care is taken to align the edges of the episiotomy wound * At the point where perineal skin begins; the suture is then passed beneath the vaginal mucosa, and repair of perineal muscle begins. The deep layer of muscles is closed first, ensuring no dead space one left behind * The skin was closed with the same continuous suture to approximate the subcutinuous tissue.

Lidocaine-prilocaine cream; mepivacaine infiltration group

Eligibility Criteria

• Age: 19 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational age 37 weeks or more
• Singleton gestation.
• Uncomplicated pregnancy.
• Vertex presentation.

You may not qualify if:

• Epidural analgesia request.
• Operative delivery.
• No other methods are used for pain control 2hours befor episiotomy
• Previous adverse reaction to local anesthetic.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination; Mepivacaine

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ahmed Maged, MD

  kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

01005227404; prof.ahmedmaged@gmail.com

Ahmed Abd ElHak, MD

CONTACT

ah.abdelhak73@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Study Start: August 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

EG (1)