Actively Recruiting

Phase 4
FEMALE
NCT06525740

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

Led by Mayo Clinic · Updated on 2026-03-04

140

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing surgery with a laparotomy for gynecologic malignancy
  • Planned inpatient admission greater than 24 hours
Not Eligible

You will not qualify if you...

  • Chronic pain requiring more than 20 morphine milligram equivalents of outpatient opioids
  • Prolonged corrected QT interval (QTc) greater than 500 milliseconds
  • Chronic kidney disease with estimated glomerular filtration rate less than 30 mL/min
  • Documented cirrhosis
  • Preoperative platelets less than 100
  • Preoperative international normalized ratio greater than 1.1
  • Inappropriate cessation of anticoagulation medications before surgery
  • Intolerance to hydromorphone or methadone
  • Contraindication to liposomal bupivacaine
  • Subsequent surgeries after the main surgery

AI-Screening

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

K

Karen Ishitani, R.N.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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