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Recruiting NCT06525740

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

Phase IV Interventional Malignant Female Reproductive System Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydromorphone, Methadone, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Malignant Female Reproductive System Neoplasm. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine

Overview

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.

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 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.

Interventions

  • Drug Hydromorphone
    Given IT
  • Drug Methadone
    Given IV
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Morphine milligram equivalents [Time frame: Up to 24 hours postoperatively]
  • Incidence of itching [Time frame: Up to 24 hours postoperatively]
  • Incidence of respiratory depression [Time frame: Up to 24 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • Undergoing surgery with a laparotomy for gynecologic malignancy
  • Planned inpatient admission greater than 24 hours

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06525740 · 24-001383 · NCI-2024-06145 · 24-001383

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗