Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

Completed · Phase 4

Conditions studied: Pain, Postpartum Depression

In brief

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.

Key facts

Study ID

NCT03470675

Run by

Northwestern University

People needed

67

Starts

2018-06-27

Expected to finish

2024-06-20

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years of age
• English-speaking
• Vaginal delivery (spontaneous or assisted)
• A full-term fetus (>37 weeks' gestation)
• OASIS as assessed by obstetrical provider
• Functional epidural analgesia at time of delivery
• Patient amenable to follow-up in specialty perineal clinic within the first week postpartum

You may not qualify if…

• Previous pelvic surgery
• History of chronic pelvic pain
• History of recurrent urinary tract infections
• Women with known malformations of their urinary tract
• True allergies to ketamine and/or morphine
• Preeclampsia or hypertensive disorder at the time of delivery
• Obstructive sleep apnea

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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