Dosing of Methadone for Spine Surgery

Phase 2

Recruiting

• Conditions: Pain, Postoperative
• Interventions: Drug: Standard dosing of methadone; Drug: Aliquots of methadone titrated to apnea

• Registration Number: NCT03605901
• Lead Sponsor: University of Florida

Brief Summary

This study compares two methods of dosing methadone for complex spine cases

Detailed Description

Patients with spine surgery experience a significant amount of pain that can interfere with healing, rehabilitation and contribute to morbidity in the post-operative period. This study will compare post-operative opioid requirement at 24 and 48 hours to determine if methadone given in small aliquots until respiratory depression can act as a self-control to determine the correct dose required.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-30
• Study Start: 2019-03-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28
• Primary Completion: 2025-05-09
• Study Completion: 2025-05-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dosing of methadone	Standard dosing of methadone	Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
Aliquots of methadone titrated to apnea	Aliquots of methadone titrated to apnea	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.

Primary Outcome Measures

Name	Time	Method
Change in opioid requirement for complex spine surgery patients	Changes from baseline (pre-op) up to 72 hours post-op	Titrating methadone to respiratory depression allows the patient to act as his own control determining the dose he will require, improving pain control and consequently decreasing side effects and complications.

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States