Actively Recruiting
Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
Led by Mayo Clinic · Updated on 2026-03-04
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates postoperative pain relief options for patients with gynecologic cancer undergoing surgery. It compares intravenous methadone, a long-acting opioid that binds to opioid receptors in the central nervous system, with intrathecal hydromorphone, which works similarly to an epidural by affecting the brain and nervous system's response to pain. The study aims to determine if methadone provides pain relief comparable to intrathecal hydromorphone in this patient population. Participants are randomly assigned to one of two groups. One group receives methadone intravenously during the induction of general anesthesia for their standard surgery, while the other group receives hydromorphone injected into the fluid-filled space around the spinal cord before anesthesia induction. After the surgical procedure and study intervention, patients are monitored and followed up for one month. During the study, researchers measure pain scores at baseline, when leaving the post-anesthesia care unit, and at 4, 8, 12, and up to 24 hours after surgery. They also track the amount of opioids used, as well as side effects like itching and respiratory depression within 24 hours postoperatively. The follow-up visit at one month helps evaluate longer-term outcomes related to pain management and recovery.
CONDITIONS
Brief Title
Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing surgery with a laparotomy for gynecologic malignancy
- Planned inpatient admission greater than 24 hours
You will not qualify if you...
- Chronic pain requiring more than 20 morphine milligram equivalents of opioid medications as an outpatient
- Prolonged corrected QT interval (QTc) greater than 500 ms
- Chronic kidney disease with estimated glomerular filtration rate less than 30 mL/min
- Documented cirrhosis
- Preoperative platelets less than 100
- Preoperative international normalized ratio greater than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive either intravenous methadone during induction of general anesthesia or an intrathecal injection of hydromorphone prior to induction for surgery.
1 surgery visit (in-person)
Duration - Up to 24 hours postoperatively
Participants are followed up for pain and safety assessments after surgery, including monitoring pain scores and side effects.
1 visit (in-person) up to 24 hours after surgery
Duration - Approximately 1 month
Participants return for a follow-up visit approximately 1 month after surgery to assess recovery and outcomes.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
K
Karen Ishitani, R.N.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here