Back to resultsPudendal Nerve Block for Post-Episiotomy Pain Relief
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Pudendal Nerve Block
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility 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
Sites / Locations
- Ain Shams University Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Unilateral PNB
Bilateral PNB
Arm Description
Unilateral Pudendal Nerve Block
Bilateral Pudendal Nerve Block
Outcomes
Primary Outcome Measures
Visual Analogue Scale for pain scoring
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03944291
Brief Title
Pudendal Nerve Block for Post-Episiotomy Pain Relief
Official Title
Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Bupivacaine
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unilateral PNB
Arm Type
Active Comparator
Arm Description
Unilateral Pudendal Nerve Block
Arm Title
Bilateral PNB
Arm Type
Active Comparator
Arm Description
Bilateral Pudendal Nerve Block
Intervention Type
Procedure
Intervention Name(s)
Pudendal Nerve Block
Other Intervention Name(s)
Bupivacaine
Intervention Description
Pudendal Nerve Block
Primary Outcome Measure Information:
Title
Visual Analogue Scale for pain scoring
Description
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
Time Frame
48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Pudendal Nerve Block for Post-Episiotomy Pain Relief
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