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Compares treatment options for Malignant Female Reproductive System Neoplasm
Official title Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
ClinicalTrials.gov ID: NCT06525740
What this study is testing
What is Hydromorphone?
Hydromorphone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant female reproductive system neoplasm.
Also referred to as (-)-Hydromorphone, Dihydromorphinone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, women only
You may be able to join if
- Undergoing surgery with a laparotomy for gynecologic malignancy
- Planned inpatient admission greater than 24 hours
You likely can't join if
- 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
See the full eligibility criteria
- Undergoing surgery with a laparotomy for gynecologic malignancy
- Planned inpatient admission greater than 24 hours
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.