NCT06525740RecruitingPhase 4
Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 24 Jul 2024
- Start date
- 3 Sept 2024
- Primary completion date
- 1 Sept 2029
- Lead sponsor
- Mayo Clinic
- Diseases
- Childhood cancers
- NCT number
- NCT06525740
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 140
- From 3 Sept 2024 to the primary completion date, 1 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic pain requiring greater than 20 morphine milligram equivalents of opioid medications as an outpatient
- Inappropriate cessation of anticoagulation medications prior to surgery
- Subsequent surgeries after index surgery
Lab values
- Prolonged corrected QT interval (QTc) \> 500ms
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30 milliliters per minute (mL/min)
- Preoperative platelets (PLT) \< 100
- Preoperative international normalized ratio (INR) \> 1.1
Other
- Documented cirrhosis
- Intolerance to hydromorphone or methadone
- Contraindication to administration of liposomal bupivacaine
Who the study is looking for
- Undergoing surgery with a laparotomy for gynecologic malignancy
- Planned inpatient admission greater than 24 hours
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.