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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Surgery
• Intervention / Treatment: Drug: Methadone

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Methadone bolus during surgery; Patients will be administered methadone 0.2 mg/kg (max 20 mg).	Drug: Methadone; methadone 0.2 mg/kg IV.
No Intervention: No Methadone during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid requirement in morphine equivalent	To see if giving methadone during surgery reduces the need for other pain medications after surgery	within 72 hours post-surgery

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Jess Brallier, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Methadone; Pain Levels; Pain Medications; 22-015
• Additional Relevant MeSH Terms: Organic Chemicals; Ketones; Methadone
• Other Study ID Numbers: 22-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No