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Opioid Analgesic

Pain Management Interventions for Postpartum Pain

Phase 4
Waitlist Available
Led By Feyce Peralta, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years of age
Functional epidural analgesia at time of delivery
Must not have
History of recurrent urinary tract infections
Previous pelvic surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after vaginal delivery
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will compare the effects of three different interventions on perineal pain in postpartum women 1 week after sustaining an obstetric anal sphincter injury.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include typical reactions to opioids like morphine (nausea, drowsiness, constipation) and ketamine (dizziness, mood changes). Saline is generally safe but can cause discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I will have an epidural for pain relief during delivery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had multiple urinary tract infections.
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I have had surgery in my pelvic area before.
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I have been diagnosed with obstructive sleep apnea.
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I had high blood pressure or preeclampsia when I gave birth.
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I have a history of chronic pain in my pelvic area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week after vaginal delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week after vaginal delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
Secondary study objectives
Assessment of maternal-infant bonding
Brief Pain Inventory (Short Form) Modified
Female sexual function
+5 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,645 Previous Clinical Trials
958,527 Total Patients Enrolled
47 Trials studying Pain
3,719 Patients Enrolled for Pain
Feyce Peralta, MDPrincipal InvestigatorNorthwestern University
5 Previous Clinical Trials
574 Total Patients Enrolled
2 Trials studying Pain
306 Patients Enrolled for Pain

Media Library

Epidural morphine 3 mg + IV ketamine 0.3 mg/kg (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT03470675 — Phase 4
Pain Research Study Groups: Epidural saline + IV saline, Epidural morphine 3 mg + IV saline, Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Pain Clinical Trial 2023: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg Highlights & Side Effects. Trial Name: NCT03470675 — Phase 4
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03470675 — Phase 4
~9 spots leftby Nov 2025
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