NCT03470675

Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Pain
• Postpartum Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-27
• Primary completion: 2024-05-20
• Completion: 2024-06-20
• First posted: 2018-03-20
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study