Status:
ACTIVE_NOT_RECRUITING
Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Spinal Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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. Parti...
Eligibility Criteria
Inclusion
- Adult patients (between 18-75 years of age) scheduled for extradural spine surgery with instrumentation (greater than or equal to two levels and including minimally invasive) of expected duration ≥ 2 hours
- Postoperative hospital stay expected to be ≥ 2 nights at the time of consent
Exclusion
- 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.
- Abnormal liver function tests as related to the MSK guidelines for use of IV acetaminophen: ALT greater than 2 x Upper Limit of Normal (\> 75 U/L)
- Serum Creatinine \> 1.5 mg/dl
- Instrumented spine cases of less than 2 levels
- All non-instrumented spine cases
- All intradural tumor resections
- All "take backs" that occur within 72 hours of surgery (wound revisions, hematomas, etc.)
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05417100
Start Date
June 6 2022
End Date
June 1 2026
Last Update
January 28 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065