RecruitingPhase 4NCT06525740

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

Sponsor

Mayo Clinic

Enrollment

140 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Malignant Female Reproductive System Neoplasm

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.

Eligibility

Sex: FEMALE

Inclusion Criteria2

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

Exclusion Criteria10

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