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

NCT05417100 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: 22-015
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Spinal Surgery

Keywords

Methadone; Pain Levels; Pain Medications; 22-015

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Methadone bolus during surgery

ACTIVE COMPARATOR

Patients will be administered methadone 0.2 mg/kg (max 20 mg).

Drug: Methadone

No Methadone during surgery

NO INTERVENTION

No Methadone during surgery

Interventions

Methadone DRUG

methadone 0.2 mg/kg IV.

Methadone bolus during surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Methadone

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Jess Brallier, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: June 6, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)