Comparing methadone and hydromorphone for pain relief after gynecologic cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IV trial evaluates the effectiveness of intravenous methadone compared to intrathecal hydromorphone for managing postoperative pain in patients undergoing surgery for gynecologic cancer. Patients will be randomly assigned to receive either methadone during anesthesia induction or hydromorphone through an intrathecal injection prior to surgery. The study aims to determine if methadone can provide similar pain relief as hydromorphone, potentially offering a long-acting alternative for postoperative care. Participants will be monitored for one month following the intervention to assess pain management outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Sean C. Dowdy, M.D. — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.