Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydromorphone | Drug | — | UNRESOLVED |
| Methadone | Drug | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (methadone)
- description
- Patients receive methadone IV during induction of general anesthesia for SOC surgery.
- interventionNames
- Drug: Methadone
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (hydromorphone)
- description
- Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.
- interventionNames
- Drug: Hydromorphone
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Difference in pain scores
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available