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NCT Number: NCT06525740

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

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.

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Key information

Conditions

Malignant Female Reproductive System Neoplasm

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydromorphone

Drug

Given IT

Other names: (-)-Hydromorphone, Dihydromorphinone, Hydromorphon

Methadone

Drug

Given IV

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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

    Will be assessed per group [intravenous (IV) methadone or intrathecal (IT) hydromorphone] by patient-reported pain on a scale of 0-10 where 0=no pain and 10=worst pain imaginable.

Secondary outcomes

  1. Morphine milligram equivalents

    Time frame: Up to 24 hours postoperatively

    Will be assessed by the number of morphine milligram equivalents utilized for the first 24 hours postoperatively.

  2. Incidence of itching

    Time frame: Up to 24 hours postoperatively

    Will be assessed by the number of patients patient-reported itching on follow-up visits.

  3. Incidence of respiratory depression

    Time frame: Up to 24 hours postoperatively

    Will be assessed by the number of patients who experience incidents of respiratory depression, defined breathing less frequently as a result of opioid administration.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Karen Ishitani, R.N.

CONTACT

[email protected]

507-538-5355

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jul 29, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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