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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Pudendal Nerve Block for Post-Episiotomy Pain Relief

Clinicaltrials.gov identifier NCT03944291

Recruitment Status Completed

First Posted May 9, 2019

Last update posted January 28, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Pain, Postoperative
  • Intervention/Treatment: Procedure: Pudendal Nerve Block
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 102 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Bupivacaine
  • 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 2019
  • Actual Primary Completion Date: January 2020
  • Actual Study Completion Date: January 2020
Arms and interventions
Arm Intervention/treatment
Active Comparator: Bilateral PNB
Bilateral Pudendal Nerve Block
Procedure: Pudendal Nerve Block
Pudendal Nerve Block
Active Comparator: Unilateral PNB
Unilateral Pudendal Nerve Block
Procedure: Pudendal Nerve Block
Pudendal Nerve Block
Outcome Measures
  • Primary Outcome Measures: 1. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 40 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

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
Contacts
Locations

Egypt
Ain Shams University Maternity Hospital
Cairo

Sponsors and Collaborators

Ain Shams University

More Information
  • Responsible Party: Ain Shams University
  • ClinicalTrials.gov Identifier: NCT03944291 History of Changes
  • Other Study ID Numbers: AS1871
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: January 28, 2020
  • Last Verified: January 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