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

NCT06525740 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 24-001383NCI-2024-06145
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Difference in pain scores

  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.

  Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively

Secondary Outcomes (3)

• Morphine milligram equivalents

  Up to 24 hours postoperatively

• Incidence of itching

  Up to 24 hours postoperatively

• Incidence of respiratory depression

  Up to 24 hours postoperatively

Study Arms (2)

Arm I (methadone)

EXPERIMENTAL

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

Drug: Methadone; Other: Questionnaire Administration

Arm II (hydromorphone)

EXPERIMENTAL

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

Drug: Hydromorphone; Other: Questionnaire Administration

Interventions

Hydromorphone DRUG

Given IT

Also known as: (-)-Hydromorphone, Dihydromorphinone, Hydromorphon

Arm II (hydromorphone)

Methadone DRUG

Given IV

Arm I (methadone)

Questionnaire Administration OTHER

Ancillary studies

Arm I (methadone); Arm II (hydromorphone)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Hydromorphone; Methadone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Ketones; Organic Chemicals

Study Officials

• Sean C. Dowdy, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Karen Ishitani, R.N.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

US (1)