CClinicalTrials.gg
Status unknownNCT03264586Updated Aug 29, 2017

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

A Phase 4 interventional study of Lidocaine-prilocaine cream and mepivacaine infiltration group in Episiotomy Pain, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 19 Years to 39 Years. Per ClinicalTrials.gov, last updated 2017-08-29.

Sponsored by Cairo University · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
19 Years to 39 Years
Sex
Female
01

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.

Read the 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
02

Conditions studied

  • Episiotomy Pain
03

Who can participate

Ages eligible
19 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • 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 · 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

    Drug: mepivacaine infiltration group · Procedure: mediolateral episiotomy

Interventions

  • DrugLidocaine-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.

    Also known as: EMLA cream

  • Drugmepivacaine 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

    Also known as: 1% mepivacaine

  • Proceduremediolateral 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.

05

What researchers measure

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

    Time frame: 24 hours after delivery

06

Study locations

1 site
  • Kasr Alainy medical school
    Cairo, 12151, Egypt
07

Registry details

Key details

Study ID
NCT03264586
Lead sponsor
Cairo University
Responsible party
Ahmed Maged (Professor, Cairo University) — Principal investigator
First posted
Aug 29, 2017
Start date
Aug 2017 (estimated)
Primary completion
Mar 2018 (estimated)
Completion
Mar 2018 (estimated)
Last update
Aug 29, 2017

Study contacts

Ahmed Maged, MD
Contact
prof.ahmedmaged@gmail.com
01005227404
Ahmed Abd ElHak, MD
Contact
ah.abdelhak73@gmail.com
Ahmed Maged, MD
principal investigator · kasr Alainy medical school

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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