Status:
RECRUITING
Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
Lead Sponsor:
Mayo Clinic
Conditions:
Malignant Female Reproductive System Neoplasm
Eligibility:
FEMALE
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- Undergoing surgery with a laparotomy for gynecologic malignancy
- Planned inpatient admission greater than 24 hours
Exclusion
- 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
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06525740
Start Date
September 3 2024
End Date
September 1 2029
Last Update
March 10 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905