NCT06525740 Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
| NCT ID | NCT06525740 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mayo Clinic |
| Condition | Malignant Female Reproductive System Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-09-03 |
| Primary Completion | 2029-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2024-09-03 with a primary completion date of 2029-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase IV trial compares methadone versus hydromorphone given in the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord (intrathecal) for postoperative pain relief in patients with gynecologic cancer undergo surgery. Methadone binds to opioid receptors in the central nervous system and is a long-acting opioid pain medication. Intrathecal hydromorphone works by changing the way the brain and nervous system respond to pain and is similar to an epidural. This trial may help researchers determine if methadone works as well as intrathecal hydromorphone for pain relief after surgery in patients with gynecologic cancer.
Eligibility 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
Contact & Investigator
Sean C. Dowdy, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06525740 clinical trial?
This trial is open to female participants only, studying Malignant Female Reproductive System Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06525740 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06525740 currently recruiting?
Yes, NCT06525740 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06525740 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06525740 clinical trial?
NCT06525740 is sponsored by Mayo Clinic. The principal investigator is Sean C. Dowdy, M.D. at Mayo Clinic in Rochester. The trial plans to enroll 140 participants.