Pudendal Nerve Block for Post-Episiotomy Pain Relief

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-01-20

Brief Summary

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

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Bupivacaine

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Unilateral PNB

Unilateral Pudendal Nerve Block

Group Type ACTIVE_COMPARATOR

Pudendal Nerve Block

Intervention Type PROCEDURE

Pudendal Nerve Block

Bilateral PNB

Bilateral Pudendal Nerve Block

Group Type ACTIVE_COMPARATOR

Pudendal Nerve Block

Intervention Type PROCEDURE

Pudendal Nerve Block

Interventions

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Pudendal Nerve Block

Intervention Type PROCEDURE

Other Intervention Names

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Bupivacaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No