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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Female Reproductive System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Drug: Hydromorphone; Drug: Methadone

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Karen Ishitani, R.N.; Phone Number: 507-538-5355; Email: Ishitani.Karen@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Karen Ishitani, RN; Phone Number: 507-538-5355; Email: Ishitani.Karen@mayo.edu
      • Principal Investigator: Sean C. Dowdy, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (methadone); Patients receive methadone IV during induction of general anesthesia for SOC surgery.	Other: Questionnaire Administration; Ancillary studies; Drug: Methadone; Given IV
Experimental: Arm II (hydromorphone); Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.	Other: Questionnaire Administration; Ancillary studies; Drug: Hydromorphone; Given IT; Other Names: (-)-Hydromorphone; Dihydromorphinone; Hydromorphon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine milligram equivalents	Will be assessed by the number of morphine milligram equivalents utilized for the first 24 hours postoperatively.	Up to 24 hours postoperatively
Incidence of itching	Will be assessed by the number of patients patient-reported itching on follow-up visits.	Up to 24 hours postoperatively
Incidence of respiratory depression	Will be assessed by the number of patients who experience incidents of respiratory depression, defined breathing less frequently as a result of opioid administration.	Up to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Sean C. Dowdy, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Genital Neoplasms, Female; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Ketones; Hydromorphone; Methadone
• Other Study ID Numbers: 24-001383 (Other Identifier: Mayo Clinic in Rochester); NCI-2024-06145 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No