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Methadone vs. Hydromorphone for Postoperative Pain in Gynecologic Cancer Surgery

This study is comparing two pain medications, methadone and hydromorphone, for pain relief after surgery for gynecologic cancer. Methadone is given into a vein (intravenously, IV), while hydromorphone is given into the fluid around the spinal cord (intrathecally, IT), similar to an epidural. Researchers want to see if methadone works as well as intrathecal hydromorphone to manage pain after surgery. You may be able to join if you are a woman having surgery for gynecologic cancer that requires a hospital stay longer than 24 hours. The main goal is to compare pain scores at different times after surgery, up to 24 hours. The study is currently recruiting 140 participants, but its overall status is unclear.

Study design
This is an interventional study where 140 women will be randomly assigned to receive either intravenous methadone or intrathecal hydromorphone. This helps researchers compare the effects of each medication.
What's involved
You would receive either methadone or hydromorphone during your surgery. Pain scores will be measured at specific times after surgery, up to 24 hours.
Compensation
Not stated in the trial record.
Follow-up
After the study intervention, patients are followed up at 1 month.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06525740

Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery

Recruiting
PHASE4All AgesInterventionalSupportive care
Mayo Clinic
~140 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:HydromorphoneMethadoneQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in pain scores
Measured over Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively

Conditions

Malignant Female Reproductive System Neoplasm

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Malignant Female Reproductive System Neoplasm

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Sean C. Dowdy, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Undergoing surgery with a laparotomy for gynecologic malignancy
Planned inpatient admission greater than 24 hours

Exclusion

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

What this trial measures

  • Difference in pain scoresBaseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively

    Will be assessed per group \[intravenous (IV) methadone or intrathecal (IT) hydromorphone\] by patient-reported pain on a scale of 0-10 where 0=no pain and 10=worst pain imaginable.