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Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
Who can join
All ages · Women
Full 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
About the study
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.
What is being tested
- Hydromorphone (drug)
- Methadone (drug)
- Questionnaire Administration (other)
Sponsor: Mayo Clinic · Participants: 140 · Started: Sep 3, 2024
Contact the study team
- Clinical Trials Referral Office · Phone: 855-776-0015
- Karen Ishitani, R.N. · Phone: 507-538-5355
Official record on ClinicalTrials.gov — NCT06525740
Locations in the U.S.
| Minnesota | Mayo Clinic in Rochester, Rochester |
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.