CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 67 enrolled
Drug / intervention
Epidural saline + IV saline +2 moredrug
Likely dose
Epidural morphine 3 mg + IV salinefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03470675
NCT03470675Phase 4Completed
CompareCT.gov

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

Northwestern University·interventional·Posted Mar 20, 2018·Updated Apr 24, 2026

In Brief

A Phase 4 clinical trial evaluating Epidural saline + IV saline, Epidural morphine 3 mg + IV saline, and 1 other intervention for Pain and Postpartum Depression. Completed, enrolled 67 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postpartum Depression
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 20, 2018
Enrollment StartJun 27, 2018
Primary CompletionMay 20, 2024
Study CompletionJun 20, 2024
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 8.3 years ago

Interventions

Epidural saline + IV salinedrug

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

Epidural morphine 3 mg + IV salinedrug

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

Epidural morphine 3 mg + IV ketamine 0.3 mg/kgdrug

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