Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
- Conditions
- Malignant Female Reproductive System Neoplasm
- Interventions
- Registration Number
- NCT06525740
- Lead Sponsor
- Mayo Clinic
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 140
- Undergoing surgery with a laparotomy for gynecologic malignancy
- Planned inpatient admission greater than 24 hours
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (methadone) Questionnaire Administration Patients receive methadone IV during induction of general anesthesia for SOC surgery. Arm II (hydromorphone) Questionnaire Administration Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery. Arm I (methadone) Methadone Patients receive methadone IV during induction of general anesthesia for SOC surgery. Arm II (hydromorphone) Hydromorphone Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.
- Primary Outcome Measures
Name Time Method Difference in pain scores Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively 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.
- Secondary Outcome Measures
Name Time Method Morphine milligram equivalents Up to 24 hours postoperatively Will be assessed by the number of morphine milligram equivalents utilized for the first 24 hours postoperatively.
Incidence of itching Up to 24 hours postoperatively Will be assessed by the number of patients patient-reported itching on follow-up visits.
Incidence of respiratory depression Up to 24 hours postoperatively Will be assessed by the number of patients who experience incidents of respiratory depression, defined breathing less frequently as a result of opioid administration.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States