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Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

NCT03470675 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-04-24

Study results available
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Summary

Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS.

This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS.

The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.

Conditions

Interventions

DRUG

Epidural saline + IV saline

Sterile saline injection in the epidural catheter and in the intravenous catheter

DRUG

Epidural morphine 3 mg + IV saline

Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter

DRUG

Epidural morphine 3 mg + IV ketamine 0.3 mg/kg

Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter

Sponsors & Collaborators

Principal Investigators

  • Feyce Peralta, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2024-05-20
Completion
2024-06-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03470675 on ClinicalTrials.gov