Pain Management Interventions for Postpartum Pain

Overseen By Feyce M Peralta, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Northwestern University

Must not be taking: Ketamine, Morphine

Disqualifiers: Previous pelvic surgery, Chronic pelvic pain, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to manage pain after serious tears during childbirth, known as obstetric anal sphincter injuries (OASIS). It compares the effects of a placebo, a combination of low-dose intravenous ketamine (an anesthetic) plus epidural morphine, and epidural morphine alone on pain relief one week postpartum. Women who have had a vaginal delivery at full term and experienced these specific tears might be suitable candidates. The goal is to identify the most effective pain management option to enhance recovery and overall quality of life. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients and offering a chance to contribute to improved care for others.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research shows that both epidural morphine and IV ketamine have been studied for their safety in managing pain. Ketamine can lower pain and reduce the need for extra painkillers after surgery. It may also lessen the risk of nausea and vomiting. However, some studies mention that ketamine might cause side effects like dizziness or feeling "out of it" temporarily.

Epidural morphine, often used for pain relief after childbirth, effectively reduces pain. It may cause side effects like itching or nausea, and in rare cases, could lead to breathing problems, especially with higher doses. The 3 mg dose under study is generally considered safe.

Overall, both treatments have been used in medical settings and have known benefits and risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for postpartum pain because they offer a fresh approach to pain management, especially following obstetric anal sphincter injuries. While standard care often involves oral pain medications like acetaminophen or ibuprofen, these treatments utilize an epidural morphine combined with either intravenous ketamine or saline. Ketamine is particularly intriguing because it targets different pain pathways in the brain, potentially offering more effective pain relief without the need for higher doses of opioids. This combination could provide faster and more comprehensive pain relief, helping new mothers recover more comfortably and quickly.

What evidence suggests that this trial's treatments could be effective for perineal pain after obstetric anal sphincter injuries?

Research has shown that epidural morphine effectively reduces pain after childbirth. In this trial, some participants will receive epidural morphine combined with IV saline, which can significantly ease pain for women with severe tears during vaginal delivery. Other participants will receive epidural morphine combined with IV ketamine. Studies have found that adding ketamine to morphine provides effective pain relief and might reduce the need for additional morphine. Previous research demonstrated that low doses of ketamine and morphine together successfully manage pain after surgeries, suggesting this could be a promising method for postpartum pain relief. Overall, both options—using epidural morphine alone or combined with ketamine—show potential for managing pain after childbirth injuries. ^{6 7 8 9 10}

Who Is on the Research Team?

Feyce M Peralta, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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)

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) to manage acute pain after OASIS

1 week

1 visit (in-person)

Follow-up

Participants are monitored for perineal pain and other outcomes such as maternal-infant bonding, sexual function, and quality of life

3 months

Multiple assessments (in-person and virtual)

Long-term follow-up

Participants are assessed for perineal pain and other outcomes 1 year after delivery

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
• Epidural morphine 3 mg + IV saline
• Epidural saline + IV saline
• Obstetric Anal Sphincter Injuries
• Perineal Pain Management

Trial Overview 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.

How Is the Trial Designed?

Group I: Epidural morphine 3 mg + IV saline Active Control 1 Intervention

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

Group II: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg Active Control 1 Intervention

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

Group III: Epidural saline + IV saline Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03470675?term=AREA%5BConditionSearch%5D(%22Postpartum%20Depression%22)%20AND%20AREA%5BInterventionSearch%5D(%22anesthetics,%20intravenous%22)&rank=5

Postpartum Perineal Pain After Obstetric Anal Sphincter ... This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474748/

Low-dose epidural morphine for postpartum pain relief Epidural morphine administration following vaginal delivery reduces postpartum pain; however, side effects may occur.

3. sigma.larvol.com sigma.larvol.com/ott.php?e1=1456&e2=&sourcepg=TZ&sr=now&er=1+month&ipwnd=on&rlink=,sourcepg=TZ,itype=0,1&rflag=1&page=2

Online Trial Tracker NCT03470675: Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries ... IV saline, Epidural morphine 3 mg + IV ketamine 0.3 mg/kg. Northwestern ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3106386/

Role of epidural ketamine for postoperative analgesia after ... A combination of low-dose epidural ketamine and morphine results in effective postoperative analgesia and also reduces morphine requirement.

5. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.988392/full

Epidural esketamine and morphine for postoperative ... In the present study, esketamine in combination with morphine was demonstrated to be effective for parturients who underwent cesarean delivery. We found that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11679605/

The Impact of Ketamine on Outcomes in Acute Pain ... Evidence shows that intravenous ketamine reduces the pain intensity, postoperative opioid use, and the risk of vomiting and nausea while improving analgesia.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03896230

Ketamine for Pain in the Emergency Department This study will be the first to evaluate ketamine for acute pain in the emergency department at standard of care doses (0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg IV) ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2804098

RETRACTED: Efficacy and Safety of Esketamine for ... This randomized clinical trial investigates the sedative and analgesic effects of intravenous esketamine used before childbirth via cesarean ...

9. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.70190

Intravenous ketamine to prevent post‐partum depression ... However, ketamine administration resulted in a reduction in postoperative pain scores and total opioid consumption but increased the incidence ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6023582/

Consensus Guidelines on the Use of Intravenous Ketamine ... Overall, we conclude that moderate evidence supports use of subanesthetic IV ketamine bolus doses (up to 0.35 mg/kg) and infusions (up to 1 mg/kg per hour) as ...