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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 month
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month for reporting.

Treatment Details

Study Objectives

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

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
1,576 Previous Clinical Trials
911,855 Total Patients Enrolled
46 Trials studying Pain
3,693 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned the application of Epidural morphine 3 mg + IV ketamine 0.3 mg/kg?

"Due to its Phase 4 status, indicating that Epidural morphine 3 mg + IV ketamine 0.3 mg/kg is approved for medical use, we have allocated a score of 3 indicating it has strong safety ratings."

Answered by AI

Is there still an opportunity for prospective participants to join this experiment?

"As per clinicaltrials.gov, this trial is presently in search of participants. It was initially posted on June 27th 2018 and the most recent update came on January 11th 2022."

Answered by AI

Could you please describe the results of prior experiments involving Epidural morphine 3 mg + IV ketamine 0.3 mg/kg?

"Presently, 155 clinical trials are assessing the efficacy of Epidural morphine 3 mg + IV ketamine 0.3 mg/kg. Of those studies, 34 have progressed to Phase 3. Although Boston, Massachusetts is at the epicentre of this research area with numerous trials running there, a total of 285 sites across America offer these treatments."

Answered by AI

What medical treatments are Epidural morphine 3 mg + IV ketamine 0.3 mg/kg usually employed for?

"Pain, general anaesthesia and induction/maintenance of general anaesthesia can be successfully treated using a combination of epidural morphine (3mg) plus an intravenous dose of ketamine at 0.3 mg/kg."

Answered by AI

How many participants are engaging in this trial altogether?

"Affirmative. An examination of clinicaltrials.gov data reveals that this medical study, which was published on June 27th 2018, is actively recruiting patients. 160 volunteers need to be sourced from one particular location."

Answered by AI

Who else is applying?

What site did they apply to?
Northwestern University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~2 spots leftby May 2024