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

67 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug combination of epidural morphine and IV ketamine for postpartum pain management?

Research shows that low-dose ketamine can enhance the pain-relieving effects of morphine, as seen in studies where ketamine reduced the need for additional pain medication after surgery. Additionally, epidural morphine has been effective in providing pain relief for up to 24 hours post-surgery, suggesting that the combination could be beneficial for managing postpartum pain. ^{1 2 3 4 5}

Is the combination of epidural morphine and IV ketamine safe for pain management?

Research shows that adding low-dose ketamine to epidural morphine for pain management in cancer patients did not result in serious side effects, suggesting it is generally safe. However, one study noted a patient experienced hallucinations, indicating some risk of side effects. ^{1 5 6 7 8}

How does the drug combination of epidural morphine and IV ketamine differ from other treatments for postpartum pain?

This drug combination is unique because it combines epidural morphine, which is effective for pain relief, with intravenous ketamine, which can enhance the pain-relieving effects of morphine and potentially reduce the need for additional pain medication. This approach may offer more effective pain management compared to using morphine or ketamine alone. ^{1 2 3 5 9}

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.

Research Team

Feyce M Peralta, MD

Principal Investigator

Northwestern University

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)

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Epidural ketamine for postoperative pain relief after gynecologic operations: a double-blind study and comparison with epidural morphine. [2013]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Low-dose ketamine with multimodal postcesarean delivery analgesia: a randomized controlled trial. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Analgesia for acute musculoskeletal trauma: low-dose subcutaneous infusion of ketamine. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

Epidural ketamine for postoperative analgesia. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Low-dose intravenous ketamine potentiates epidural analgesia after thoracotomy. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Beneficial effect of low-dose ketamine addition to epidural administration of morphine-bupivacaine mixture for cancer pain in two cases. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Intrathecal ketamine reduces morphine requirements in patients with terminal cancer pain. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Preoperative epidural ketamine in combination with morphine does not have a clinically relevant intra- and postoperative opioid-sparing effect. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

PCA ketamine and morphine after abdominal hysterectomy. [2019]