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

Phase 4RecruitingNCT06525740

Mayo Clinic140 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

140

Conditions

Malignant Female Reproductive System Neoplasm

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Morphine milligram equivalents

Will be assessed by the number of morphine milligram equivalents utilized for the first 24 hours postoperatively.

Time frame: Up to 24 hours postoperatively

Incidence of itching

Will be assessed by the number of patients patient-reported itching on follow-up visits.

Time frame: 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.

Time frame: Up to 24 hours postoperatively

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts