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Opioid Analgesic

Methadone for Pain Management in Spinal Surgery

Phase 3
Recruiting
Led By Jess Brallier, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postoperative hospital stay expected to be ≥ 2 nights at the time of consent
Adult patients (between 18-75 years of age) scheduled for extradural spine surgery with instrumentation (≥ two levels and including minimally invasive) of expected duration ≥ 2 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 72 hours post-surgery
Awards & highlights

Study Summary

This trial is testing whether giving methadone during spinal surgery can help manage pain better than other standard pain medications. Researchers will compare methadone with a placebo to see which one works best.

Who is the study for?
Adults aged 18-75 scheduled for certain spinal surgeries lasting over 2 hours and a hospital stay of at least 2 nights can join. Excluded are those with recent methadone use, opioid antagonists, major psychiatric disorders, high BMI or heart issues, pregnant/breastfeeding women, kidney dysfunction, specific spine cases or drug misuse history.Check my eligibility
What is being tested?
The study is testing if methadone given during spinal surgery reduces pain and the need for other pain meds after surgery better than a saline placebo. Pain levels and additional medication needs will be compared between the two groups post-surgery.See study design
What are the potential side effects?
Methadone may cause side effects such as nausea, drowsiness, constipation, respiratory depression (slow breathing), confusion or mood changes. The severity of side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I expect to stay in the hospital for at least 2 nights after surgery.
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I am between 18-75 years old and scheduled for a specific spine surgery lasting 2+ hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 72 hours post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 72 hours post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
opioid requirement in morphine equivalent

Trial Design

2Treatment groups
Active Control
Group I: Methadone bolus during surgeryActive Control1 Intervention
Patients will be administered methadone 0.2 mg/kg (max 20 mg).
Group II: No Methadone during surgeryActive Control1 Intervention
No Methadone during surgery

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,931 Previous Clinical Trials
597,494 Total Patients Enrolled
Jess Brallier, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Methadone (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05417100 — Phase 3
Spinal Surgery Clinical Trial 2023: Methadone Highlights & Side Effects. Trial Name: NCT05417100 — Phase 3
Spinal Surgery Research Study Groups: Methadone bolus during surgery, No Methadone during surgery
Methadone (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05417100 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are doctors looking for new patients to enroll in this trial at the moment?

"As indicated by the clinicaltrials.gov website, this clinical trial is currently open for enrolment. The listing was first posted on 6/6/2022 and most recently updated on 11/16/2022."

Answered by AI

How many test subjects are needed for this research?

"The correct, as seen on clinicaltrials.gov this trial is looking for 210 participants and was posted on 6/6/2022. The last update to the study was 11/16/20222"

Answered by AI

How do I sign up for this opportunity to participate in research?

"This study, which is looking for a 210 participants, requires that patients have already had spinal surgery and are between 18-75 years old."

Answered by AI

Does this study include patients below the age of retirement?

"This study is looking for participants who fall between 18-75 years old."

Answered by AI

Has the Methadone drug been federally approved in the United States?

"There is both pre-existing data supporting methadone's efficacy and rounds of safety trials, so it received a score of 3."

Answered by AI
~84 spots leftby Jun 2025