Methadone for Pain Management in Spinal Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
The researchers are doing this study to find out whether giving methadone during spinal surgery helps manage pain in the first 72 hours after surgery better than other standard pain medications. Participants' pain will be measured by how much pain is reported after surgery, and how much additional pain medication is needed to lower pain levels. The researchers will look at whether giving methadone during surgery reduces the need for other pain medications after surgery. In addition, the team will compare the effects of the two standard treatments- one with methadone and one without methadone to to evaluate which one works best.
Do I have 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, you cannot participate if you are currently using methadone or have used it in the past 6 weeks, or if you are using opioid antagonists like buprenorphine.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using methadone or certain other drugs like opioid antagonists. It's best to discuss your specific medications with the trial team.
What safety data exists for using methadone in spinal surgery pain management?
The safety profile of methadone for pain management in spinal surgery has been studied in various contexts. An observational study of 1,478 patients receiving intravenous methadone for major spine surgery investigated perioperative adverse events. Methadone is known for its unique properties as a mu opioid agonist and its potential risks, such as prolonged QT interval and torsades de pointes at high doses. It is considered safer at lower doses, but more randomized controlled trials are needed to fully assess its safety compared to other opioids. Methadone-based multimodal analgesia has shown promise in reducing opioid use and improving pain control in spinal surgery, particularly in adolescents with idiopathic scoliosis. However, the optimal dosing regimen, especially in pediatric cases, remains uncertain due to limited pharmacokinetic data.12345
Is methadone safe for pain management in spinal surgery?
Methadone has been used safely in many patients for pain management after major spine surgery, but it can have side effects like a prolonged QT interval (a heart rhythm issue) and torsades de pointes (a type of dangerous heart rhythm) at very high doses. It is generally safer at lower doses, but more research is needed to fully understand its safety compared to other pain medications.12345
Is the drug Methadone promising for pain management in spinal surgery?
How is the drug methadone unique for pain management in spinal surgery?
Methadone is unique for pain management in spinal surgery because it is a long-acting opioid that can reduce postoperative pain and the need for other pain medications. Its distinct pharmacological properties make it effective for both nociceptive (pain from tissue damage) and neuropathic pain (pain from nerve damage), but it requires careful dosing and monitoring due to potential serious side effects.678910
What data supports the idea that Methadone for Pain Management in Spinal Surgery is an effective drug?
The available research shows that methadone is effective in managing pain after spinal surgery. One study found that using methadone during surgery helped reduce the need for other pain medications afterward. Another study reported that patients who received methadone had better pain control and were more satisfied with their pain management. Additionally, methadone was shown to be safe for use during major spine surgeries, with a low rate of side effects. Overall, these studies suggest that methadone is a good option for managing pain after spinal surgery.16111213
What data supports the effectiveness of the drug methadone for pain management in spinal surgery?
Who Is on the Research Team?
Jess Brallier, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Adults aged 18-75 scheduled for certain spinal surgeries lasting over 2 hours and a hospital stay of at least 2 nights can join. Excluded are those with recent methadone use, opioid antagonists, major psychiatric disorders, high BMI or heart issues, pregnant/breastfeeding women, kidney dysfunction, specific spine cases or drug misuse history.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Treatment
Participants undergo spinal surgery with or without methadone administration to manage pain
Post-operative Monitoring
Participants' pain levels and opioid requirements are monitored for 72 hours after surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Methadone
- Saline placebo
Methadone is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor