Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
Mayo Clinic
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.
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.
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- No
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 me…
Interventions
- DrugHydromorphone
Given IT
- DrugMethadone
Given IV
- OtherQuestionnaire Administration
Ancillary studies
Location
- Mayo Clinic in RochesterRochester, Minnesota