Comparing methadone and hydromorphone for pain relief after gynecologic cancer surgery
Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
This study is testing whether methadone can provide similar pain relief as hydromorphone for patients recovering from gynecologic cancer surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06525740 on ClinicalTrials.gov |
What this trial studies
This phase IV trial evaluates the effectiveness of intravenous methadone compared to intrathecal hydromorphone for managing postoperative pain in patients undergoing surgery for gynecologic cancer. Patients will be randomly assigned to receive either methadone during anesthesia induction or hydromorphone through an intrathecal injection prior to surgery. The study aims to determine if methadone can provide similar pain relief as hydromorphone, potentially offering a long-acting alternative for postoperative care. Participants will be monitored for one month following the intervention to assess pain management outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for laparotomy surgery due to gynecologic malignancy with a planned inpatient stay of more than 24 hours.
Not a fit: Patients with chronic pain requiring high doses of opioids, significant kidney issues, or contraindications to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective pain management option for patients recovering from gynecologic cancer surgery.
How similar studies have performed: Previous studies have explored opioid pain management, but this specific comparison of methadone and intrathecal hydromorphone is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergoing surgery with a laparotomy for gynecologic malignancy * Planned inpatient admission greater than 24 hours Exclusion Criteria: * Chronic pain requiring greater than 20 morphine milligram equivalents of opioid medications as an outpatient * Prolonged corrected QT interval (QTc) \> 500ms * Chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30 milliliters per minute (mL/min) * Documented cirrhosis * Preoperative platelets (PLT) \< 100 * Preoperative international normalized ratio (INR) \> 1.1 * Inappropriate cessation of anticoagulation medications prior to surgery * Intolerance to hydromorphone or methadone * Contraindication to administration of liposomal bupivacaine * Subsequent surgeries after index surgery
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Sean C. Dowdy, M.D. — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
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.