Pudendal Nerve Block for Post-Episiotomy Pain Relief

January 26, 2020 updated by: Mohamed S Sweed, MD, Ain Shams University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams university maternity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale for pain scoring
Time Frame: 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
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 20, 2020

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 26, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS1871

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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