Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery

  • End date
    Jun 13, 2025
  • participants needed
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 4 October 2022


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 methadone with the effects of a placebo to evaluate which one works best.

Condition Spinal Surgery
Treatment Saline Placebo, Methadone
Clinical Study IdentifierNCT05417100
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

Use of methadone currently or within the previous 6 weeks
Current use of a sustained-release or long-acting opioid
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
nd 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.)
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