Comparing methadone dosing methods for spine surgery pain management

Dosing of Methadone for Spine Surgery

This study is testing two different ways of giving methadone to see which method helps manage pain better after spine surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Locations: 1 site (Gainesville, Florida)
• Trial ID: NCT03605901 on ClinicalTrials.gov

What this trial studies

This study evaluates two different methods of administering methadone to manage post-operative pain in patients undergoing complex spine surgeries. It aims to determine the effectiveness of small aliquots of methadone, adjusted until respiratory depression occurs, compared to standard dosing. The primary focus is on measuring opioid requirements at 24 and 48 hours post-surgery to optimize pain management strategies. By using a self-control approach, the study seeks to identify the most effective dosing regimen for improved patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 undergoing multilevel thoracic, thoracolumbar, or lumbar spine surgery with instrumentation and fusion.

Not a fit: Patients with a history of methadone or buprenorphine use, severe obesity, or significant liver or renal failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective pain management strategies for patients recovering from spine surgery.

How similar studies have performed: While there have been studies on opioid management in post-operative settings, this specific approach using methadone dosing is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures.
2. At or between the ages 18 to 75 years.
3. Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.

Exclusion Criteria:

1. Methadone or buprenorphine use.
2. Morbid obesity with BMI\>40 Kg/m2.
3. Chronic renal failure with creatinine\>2.0 mg/dL.
4. Liver failure as determined by cirrhosis or history of fulminant hepatic failure.
5. Current or historical alcohol abuse.
6. Current or historical drug abuse.
7. Patients with history of prolonged QTc, as defined as a QTc value \>450 ms in males and \>460 ms in females.
8. Patients with ASA status IV or V.
9. Surgical diagnosis including spine tumor, infection, or trauma.
10. In the Principal Investigator's opinion is not a candidate for the study.
11. Unwilling to sign the informed consent form.

Where this trial is running

Gainesville, Florida

• UF Health — Gainesville, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Christoph Seubert, MD — University of Florida
• Study coordinator: Amy M Gunnett, RN, CCRC

Conditions Pain, Postoperative; Post-operative pain; Spine surgery; Methadone; Opioid