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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

Tracking Information
First Submitted Date  ICMJE August 25, 2017
First Posted Date  ICMJE August 29, 2017
Last Update Posted Date August 29, 2017
Estimated Study Start Date  ICMJE August 2017
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Lidocaine - Prilocaine Cream (EMLA) Versus Mepivacaine Infiltration on Pain Relief During And After Mediolateral Episiotomies
Official Title  ICMJE The Effect of Lidocaine - Prilocaine Cream (EMLA) Versus Mepivacaine Infiltration on Pain Relief During And After Mediolateral Episiotomies: A Randomized Clinical Trial
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Episiotomy Pain
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Lidocaine-prilocaine cream
    • Procedure: mediolateral episiotomy
  • 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
    Interventions:
    • Drug: mepivacaine infiltration group
    • Procedure: mediolateral episiotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 25, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 19 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03264586
Other Study ID Numbers  ICMJE 9
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmed Maged, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmed Maged, MD kasr Alainy medical school
PRS Account Cairo University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP