Clincosm LogoSign in Get a demo

Pudendal Nerve Block for Post-Episiotomy Pain Relief

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT03944291
Collaborator
(none)
102
Enrollment
1
Location
2
Arms
8.7
Actual Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pudendal Nerve Block
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
BupivacaineBupivacaine
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jan 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Unilateral PNB

Unilateral Pudendal Nerve Block

Procedure: Pudendal Nerve Block
Pudendal Nerve Block
Other Names:
  • Bupivacaine

    		•
    Active Comparator: Bilateral PNB

    Bilateral Pudendal Nerve Block

    Procedure: Pudendal Nerve Block
    Pudendal Nerve Block
    Other Names:
  • Bupivacaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analogue Scale for pain scoring [48 hours]

      visual analogue scale (VAS) from 0 to 100 with 0 corresponding to no pain at all and 100 as the worst pain the woman can describe

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Term (37 to 42 weeks gestation), primigravid women with singleton vertex fetus
    Exclusion Criteria:
    • Women with bleeding disorders, known hypersensitivity to local anesthetics, chronic use of pain medication, had previous vaginal surgery, extensive vulvovaginal infection, malposition or malpresentation were excluded from the study. Also, women who failed to deliver vaginally, had extensive perineal or cervicat tears, or had instrumental delivery were excluded from the final analysis of the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Maternity Hospital Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed S Sweed, MD, Principal Investigator, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03944291
    Other Study ID Numbers:
    • AS1871
    First Posted:
    May 9, 2019
    Last Update Posted:
    Jan 28, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Bupivacaine

    Study Results

    No Results Posted as of Jan 28, 2020