Recruiting

Methadone vs. Hydromorphone

Sponsor:

Mayo Clinic

Code:

NCT06525740

Conditions

Malignant Female Reproductive System Neoplasm

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Hydromorphone

Methadone

Questionnaire Administration

Study Details

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.

Conditions

Malignant Female Reproductive System Neoplasm

Study ID

NCT06525740

Start date

Sep 3, 2024

Status verified date

Feb, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (methadone)

Patients receive methadone IV during induction of general anesthesia for SOC surgery.

experimental: Arm II (hydromorphone)

Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.

Interventions

Hydromorphone

Given IT

Methadone

Given IV

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Difference in pain scores [ Time Frame: Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Karen Ishitani, R.N.

507-538-5355Ishitani.Karen@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Karen Ishitani, RN

507-538-5355Ishitani.Karen@mayo.edu

Principal Investigator:

Sean C. Dowdy, MD.

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 4, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-04.