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

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

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.

Study Overview

• Status: Unknown
• Conditions: Episiotomy Pain
• Intervention / Treatment: Drug: Lidocaine-prilocaine cream; Procedure: mediolateral episiotomy; Drug: mepivacaine infiltration group

Detailed Description

During the second stage of labor, women were placed in the lithotomy position. 10- Patients who were enrolled in the study were guaranteed to obtain additional anesthesia during episiotomy repair whenever pain exceeded the tolerability threshold.

11- Volunteers were assigned randomly to have either local injection of 10 ml of 1% mepivacaine or application of 5gm-dose® EMLA cream"Lidocaine- prilocaine cream(EMLA cream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)" for pain relief during episiotomy repair.

1. Group A: "EMLA group"

   • 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.

2. Group B: "mepivacaine infiltration group".

   • 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

   • All episiotomies were performed at the top of contraction as mediolateral episiotomies.

     12- Episiotomy repair

   • In all cases episiotomies was repaired with a loose, continous, non locking suture to close the vaginal mucosa and the muscular layer of the perineum using vicryl Number zero (0).
   • The suture begins about 0.5 cms above the apex of the vaginal wound The suture are evenly placed to allow for approximation of the edges of the wound without causing tension or wrinkling or over lapping.
   • At the end of the vaginal mucosal repair care is taken to align the edges of the episiotomy wound to restore the appearance of the hymenal ring, the fourchette and the beginning of the perineal skin.
   • 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, and ensuring no bleeding points are ignored.
   • The skin was closed with the same continuous suture to approximate the subcutinuous tissue.
   • The wound is cleared with antiseptic solution and covered by addressing. 14- Before leaving the delivery suite (approximately 2 hours after delivery) each patient was asked to record the severity of pain that she had experienced during perineal repair in a 10-cm visual analog scale, where 0 cm means no pain and 10 cm means unbearable pain.
   • The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale
   • Finally, women were asked to express their overall satisfaction with the anesthesia method during perineal repair with "yes" or "no" answers

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed Abd ElHak, MD; Email: ah.abdelhak73@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Gestational age 37 weeks or more
2. Singleton gestation.
3. Uncomplicated pregnancy.
4. Vertex presentation.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine-prilocaine cream; 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; 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.; Other Names: EMLA cream; 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.
Active Comparator: mepivacaine infiltration group; 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	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.; 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; Other Names: 1% mepivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics, Combined; Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination; Mepivacaine
• Other Study ID Numbers: 9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No