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NCT Number: NCT05417100

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.)

Treatment and study plan

Methadone

Drug

methadone 0.2 mg/kg IV.

Primary outcomes

  1. opioid requirement in morphine equivalent

    Time frame: within 72 hours post-surgery

    To see if giving methadone during surgery reduces the need for other pain medications after surgery

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Modulation of Post-operative Opioid Consumption and Pain by Intraoperative Methadone for Cancer Related Spinal Surgery - An Investigator Initiated Trial (IIT), Cluster Randomization Trial

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 14, 2022
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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