Methadone vs Hydromorphone for Pain Relief in Gynecologic Cancer
Trial Summary
Do I need to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic pain medications or anticoagulation medications, you may need to discuss this with the trial team.
What data supports the effectiveness of the drug hydromorphone for pain relief in gynecologic cancer?
Is hydromorphone safe for cancer pain management?
Hydromorphone has been shown to be generally safe for managing cancer pain, with common side effects including nausea, vomiting, constipation, drowsiness, and dry mouth. No severe adverse effects were observed in studies, and it is considered a tolerable alternative to other opioids like morphine and oxycodone.25678
How does the drug Methadone differ from other drugs for gynecologic cancer pain relief?
What is the purpose of this trial?
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.
Research Team
Sean C. Dowdy, M.D.
Principal Investigator
Mayo Clinic in Rochester
Eligibility Criteria
This trial is for patients with gynecologic cancer who are undergoing surgery and need postoperative pain relief. The specific eligibility criteria aren't provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely receiving the interventions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive either methadone intravenously or hydromorphone intrathecally during induction of general anesthesia for surgery
Postoperative Monitoring
Patients are monitored for pain relief and side effects such as itching and respiratory depression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Hydromorphone
- Methadone
Hydromorphone is already approved in United States, Canada, European Union for the following indications:
- Moderate to severe pain
- Moderate to severe pain
- Moderate to severe pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor