Pain Management Interventions for Postpartum Pain

Recruiting in Palo Alto (17 mi)

Overseen byFeyce M Peralta, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Northwestern University

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for English-speaking women over 18 who've had a full-term vaginal delivery and suffered from severe perineal tears. They must have had effective epidural pain relief during delivery and be able to visit a special clinic within a week after giving birth. Women with high blood pressure at delivery, sleep apnea, allergies to ketamine or morphine, past pelvic surgeries, chronic pelvic pain, frequent UTIs or urinary tract abnormalities cannot join.

Inclusion Criteria

English-speaking

Vaginal delivery (spontaneous or assisted)

A full-term fetus (>37 weeks' gestation)

+4 more

Exclusion Criteria

I have had multiple urinary tract infections.

Women with known malformations of their urinary tract

I have had surgery in my pelvic area before.

+4 more

Participant Groups

The study compares three treatments for postpartum perineal pain due to severe tearing: saline placebo via epidural and IV; epidural morphine with IV saline; and both epidural morphine plus low-dose IV ketamine. It's randomized, meaning participants are put into groups by chance to see which treatment best reduces acute pain one week after injury.

3Treatment groups

Active Control

Placebo Group

Group I: Epidural morphine 3 mg + IV salineActive Control1 Intervention

3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.

Group II: Epidural morphine 3 mg + IV ketamine 0.3 mg/kgActive Control1 Intervention

3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.

Group III: Epidural saline + IV salinePlacebo Group1 Intervention

Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.