Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
NCT ID: NCT06525740
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
140 participants
INTERVENTIONAL
2024-09-03
2029-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (methadone)
Patients receive methadone IV during induction of general anesthesia for SOC surgery.
Methadone
Given IV
Questionnaire Administration
Ancillary studies
Arm II (hydromorphone)
Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.
Hydromorphone
Given IT
Questionnaire Administration
Ancillary studies
Interventions
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Hydromorphone
Given IT
Methadone
Given IV
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned inpatient admission greater than 24 hours
Exclusion Criteria
* 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
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Sean C Dowdy, MD
Principal Investigator
Principal Investigators
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Sean C. Dowdy, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-06145
Identifier Type: REGISTRY
Identifier Source: secondary_id
24-001383
Identifier Type: OTHER
Identifier Source: secondary_id
24-001383
Identifier Type: -
Identifier Source: org_study_id
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