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Opioid Analgesic

Methadone Dosing for Postoperative Pain

Phase 2

Recruiting

Led By Nelson Algarra, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.

At or between the ages 18 to 75 years.

Must not have

Chronic renal failure with creatinine>2.0 mg/dL.

Liver failure as determined by cirrhosis or history of fulminant hepatic failure.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes from baseline (pre-op) up to 72 hours post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial found that a weight-based dosing method of methadone was more effective than a standard dosing method for treating pain after spine surgery.

Who is the study for?

This trial is for individuals aged 18-75 undergoing complex spine surgery with fusion and instrumentation, who consent to participate. It's not for those using methadone or buprenorphine, severely obese people, those with chronic kidney or liver failure, a history of substance abuse, certain heart conditions (prolonged QTc), very high surgical risk (ASA IV/V), or spine issues due to tumor, infection, or trauma.

What is being tested?

The study compares two ways of giving methadone during complex spine surgeries: the standard dosing method versus titrated doses based on the patient's breathing response. The goal is to see which method better manages postoperative pain.

What are the potential side effects?

Methadone can cause side effects like nausea, vomiting, constipation, lightheadedness or dizziness. In some cases it might lead to slow breathing rates and changes in heartbeat rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having spine surgery with hardware and fusion at multiple levels.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is low with high creatinine levels.

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I have liver failure due to cirrhosis or a severe liver episode.

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I have a spine condition due to a tumor, infection, or injury.

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I am currently using methadone or buprenorphine.

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My BMI is over 40, indicating morbid obesity.

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My health is severely limited by my illness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes from baseline (pre-op) up to 72 hours post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes from baseline (pre-op) up to 72 hours post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from baseline (pre-op) up to 72 hours post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in opioid requirement for complex spine surgery patients

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Aliquots of methadone titrated to apneaExperimental Treatment1 Intervention

Receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed.

Group II: Standard dosing of methadoneActive Control1 Intervention

Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.

0 / 8Eligibility criteria met