Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06525740
Phase
PHASE4
Status
Recruiting
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Conditions

  • Malignant Female Reproductive System Neoplasm

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydromorphone — DRUG
    Given IT
  • Methadone — DRUG
    Given IV
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Sep 3, 2024
Status verified
Feb 2026
Primary completion
Sep 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (methadone)
    Patients receive methadone IV during induction of general anesthesia for SOC surgery.
  • Experimental: Arm II (hydromorphone)
    Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.

Primary Outcome Measure

Difference in pain scores [ Time Frame: Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Karen Ishitani, RN
[email protected]
507-538-5355
Sean C. Dowdy, MD. (PRINCIPAL_INVESTIGATOR)

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