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Could a single dose of methadone during surgery cut Post-Op pain?

NCT ID NCT05417100

Symptom relief Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving methadone during spinal surgery helps control pain for the first 72 hours after surgery better than standard pain medicines. Seventeen adults having cancer-related spinal surgery took part. Researchers measured pain scores and how much extra pain medication was needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methadone
What this could lead to
If it works, this could point toward a better way to manage pain after spinal surgery, reducing the need for other opioids.
What could go wrong
This is a very small trial (17 people) and results may not apply to everyone. Methadone itself can cause side effects like breathing problems or nausea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

17 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal surgery

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

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