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

StatusRecruiting
PhasePhase 4
Started2024-09-03
View on ClinicalTrials.gov ↗

Amendment history

2026-03-02
Study Status, Oversight v3
Re-verified, no change to tracked fields
2025-03-06
Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v2
Eligibility criteria+51 characters
[...] ter 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) > 480ms500ms Chronic kidney disease with estimated glomerular filtration [...] mL/min) Documented cirrhosis Preoperative platelets (PLT) < 75100 Preoperative international normalized ratio (INR) > 1.51 Inappropriate cessation of anticoagulation medications prio [...]
Study sitescontacts updated at 1 of 1 site
2024-09-19
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-09-01→confirmed 2024-09-03
Study sitesdetails revised at 1 of 1 site
2024-07-24
Original filing
Mayo Clinic
1,015 trials monitored
See 115 trials at risk
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.
Trial Details
NCT Number NCT06525740
Lead Sponsor Mayo Clinic
Conditions Malignant Female Reproductive System Neoplasm
Enrollment 140 participants
Start Date 2024-09-03
Primary Completion 2029-09-01 (estimated)
Study Completion 2029-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-04