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

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ClinicalTrials.gov Identifier: NCT03264586
Recruitment Status : Unknown
Verified August 2017 by Ahmed Maged, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

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.


Condition or disease Intervention/treatment Phase
Episiotomy Pain Drug: Lidocaine-prilocaine cream Drug: mepivacaine infiltration group Procedure: mediolateral episiotomy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Lidocaine - Prilocaine Cream (EMLA) Versus Mepivacaine Infiltration on Pain Relief During And After Mediolateral Episiotomies: A Randomized Clinical Trial
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018


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 Name: 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
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 Name: 1% mepivacaine

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.




Primary Outcome Measures :
  1. pain [ Time Frame: 24 hours after delivery ]
    The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale



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Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264586


Contacts
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Contact: Ahmed Maged, MD 01005227404 prof.ahmedmaged@gmail.com
Contact: Ahmed Abd ElHak, MD ah.abdelhak73@gmail.com

Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD kasr Alainy medical school
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Responsible Party: Ahmed Maged, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03264586    
Other Study ID Numbers: 9
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lidocaine
Prilocaine
Mepivacaine
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined