NCT06525740

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine whether intravenous methadone can provide comparable analgesia to an intrathecal injection of hydromorphone. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive methadone intravenously (IV) during induction of general anesthesia for standard of care (SOC) surgery. ARM II: Patients receive hydromorphone intrathecally (IT) prior to induction of general anesthesia for SOC surgery. After completion of study intervention, patients are followed up at 1 month.

Conditions

• Malignant Female Reproductive System Neoplasm

Interventions

Type	Name	Description
DRUG	Hydromorphone	Given IT
DRUG	Methadone	Given IV
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2024-09-03
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2024-07-29
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study