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Opioid

Methadone vs Hydromorphone for Pain Relief in Gynecologic Cancer

Phase 4
Waitlist Available
Led By Sean C. Dowdy, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned inpatient admission greater than 24 hours
Undergoing surgery with a laparotomy for gynecologic malignancy
Must not have
Contraindication to administration of liposomal bupivacaine
Subsequent surgeries after index surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, upon leaving post-anesthesia care unit (pacu), and at 4, 8, and 12 hours, up to 24 hours postoperatively
Awards & highlights

Summary

"This trial compares methadone to hydromorphone for pain relief after surgery in gynecologic cancer patients. Methadone is a long-acting opioid that binds to receptors in the brain

Who is the study for?
This trial is for patients with gynecologic cancer who are undergoing surgery and need postoperative pain relief. The specific eligibility criteria aren't provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely receiving the interventions.
What is being tested?
The study compares two pain relief methods after surgery: methadone (a long-acting opioid) versus intrathecal hydromorphone (similar to an epidural). It aims to determine which drug provides better postoperative pain management for these patients.
What are the potential side effects?
Possible side effects of both methadone and hydromorphone include nausea, vomiting, constipation, drowsiness, confusion, respiratory depression (slow breathing), and dependency or withdrawal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will be admitted to the hospital for more than a day.
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I am having surgery through an abdominal cut for a female reproductive cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take liposomal bupivacaine due to health reasons.
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I have had surgeries after my first major cancer surgery.
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I need opioid painkillers for ongoing pain.
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My kidney function is severely reduced.
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I have been diagnosed with cirrhosis.
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I stopped taking my blood thinners before surgery when I shouldn't have.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, upon leaving post-anesthesia care unit (pacu), and at 4, 8, and 12 hours, up to 24 hours postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, upon leaving post-anesthesia care unit (pacu), and at 4, 8, and 12 hours, up to 24 hours postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in pain scores
Secondary study objectives
Incidence of itching
Incidence of respiratory depression
Morphine milligram equivalents

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (hydromorphone)Experimental Treatment2 Interventions
Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.
Group II: Arm I (methadone)Experimental Treatment2 Interventions
Patients receive methadone IV during induction of general anesthesia for SOC surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydromorphone
2005
Completed Phase 4
~4340
Methadone
2005
Completed Phase 4
~2930

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,305 Total Patients Enrolled
Sean C. Dowdy, M.D.Principal InvestigatorMayo Clinic in Rochester
~93 spots leftby Sep 2029
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