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COMPLETED
NCT03470675
PHASE4

Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

Official title: Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries: A Randomized Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

67

Start Date

2018-06-27

Completion Date

2024-06-20

Last Updated

2026-04-24

Healthy Volunteers

No

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

Locations (1)

Northwestern University

Chicago, Illinois, United States