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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
Must not have
Current use of opioid antagonist/partial antagonist (i.e. buprenorphine)
Contraindication to use of any analgesic medications listed in the ERAS pathways (acetaminophen, gabapentin, celecoxib, IV opioids)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 72 hours post-surgery
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication that includes opioid blockers.
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I cannot take certain pain medications like acetaminophen or opioids.
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I have had spine surgery on less than 2 levels.
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My spine condition does not require devices for treatment.
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My BMI is 36 or higher.
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I have a documented heart condition with weak heart pumping.
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I have had surgery to remove a tumor from within my spinal canal.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
opioid requirement in morphine equivalent

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,979 Previous Clinical Trials
599,633 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
~30 spots leftby Jun 2025
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