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

NCT03264586 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-08-29

No results posted yet for this study

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

Interventions

DRUG

Lidocaine-prilocaine cream

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.

DRUG

mepivacaine infiltration 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

PROCEDURE

mediolateral episiotomy

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Maged, MD · kasr Alainy medical school

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03264586 on ClinicalTrials.gov