Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery (NCT05417100)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (18 items).
Location: Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Use of methadone currently or within the previous 6 weeks
- Drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine, methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin).
- Current use of opioid antagonist/partial antagonist (i.e. buprenorphine).
- Current or past diagnosis of a Major Psychiatric disorder (such as Schizophrenia, dementia, delirium).
- Patients with a BMI ≥ 36 kg/m2
- 2nd or 3rd degree heart block as assessed by preoperative EKG.
- QTc \> 450 msec on preoperative EKG.
- Documentation of congestive heart failure and/or ejection fraction \< 30% if recorded in the Pre-Operative Record.
- Contraindication to use of any analgesic medications listed in the ERAS pathways (acetaminophen, gabapentin, celecoxib, IV opioids).
- Any known hypersensitivity to methadone.
- Pregnant or breastfeeding.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.