Comparing Methadone and Morphine for Pain Relief After Cesarean Delivery
Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery: a Randomized Clinical Trial
PHASE4 · Mayo Clinic · NCT06826742
This study is testing whether methadone or morphine works better for pain relief after a cesarean delivery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06826742 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of intravenous methadone versus intrathecal morphine in managing pain following scheduled cesarean deliveries. Participants will receive either 150 mcg of intrathecal morphine or 0.2 mg/kg of intravenous methadone, with a maximum dose of 20 mg. The primary focus is to assess the differences in opioid requirements within the first 48 hours post-surgery. The study will include English-speaking adults over 18 years old who are scheduled for a cesarean delivery.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults over 18 years old scheduled for a cesarean delivery.
Not a fit: Patients with contraindications to spinal anesthesia, a history of opioid intolerance, or significant respiratory or metabolic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing cesarean deliveries.
How similar studies have performed: Other studies have explored opioid management in postoperative settings, but this specific comparison of methadone and morphine is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * English-speaking * Age over 18 years old * Scheduled cesarean delivery Exclusion Criteria: * Any contraindication to the administration of a spinal technique for anesthesia * History of intolerance or adverse reaction to opioid medications * History of chronic pain, opioid use \>30 OME/day, or substance use disorder * History of obstructive sleep apnea, chronic obstructive pulmonary disease, or respiratory compromise (SpO2 \<92% on room air, or has a pre-existing oxygen requirement) * History of liver or kidney failure * Diagnosis of pre-eclampsia with current pregnancy * Depression requiring more than one medication * Planned use of CSE technique * BMI \>50.0 kg/m2 * ASA status IV, V * No prior history of an ECG demonstrating QTc \> 440ms * Surgical complication requiring conversion to general anesthesia
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Emily E Sharpe, M.D. — Mayo Clinic
- Study coordinator: Emily E Sharpe, M.D.
- Email: sharpe.emily@mayo.edu
- Phone: 507-266-9877
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cesarean Delivery, methadone, morphine, intrathecal, cesarean