Dosing of Methadone for Spine Surgery

Study Overview
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Brief Summary
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This study compares two methods of dosing methadone for complex spine cases

Detailed Description
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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.

Official Title
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Dosing of Methadone for Spine Surgery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Standard dosing of methadone
* Drug: Aliquots of methadone titrated to apnea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures. At or between the ages 18 to 75 years. Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion. Exclusion Criteria: Methadone or buprenorphine use. Morbid obesity with BMI>40 Kg/m2. Chronic renal failure with creatinine>2.0 mg/dL. Liver failure as determined by cirrhosis or history of fulminant hepatic failure. Current or historical alcohol abuse. Current or historical drug abuse. Patients with history of prolonged QTc, as defined as a QTc value >450 ms in males and >460 ms in females. Patients with ASA status IV or V. Surgical diagnosis including spine tumor, infection, or trauma. In the Principal Investigator's opinion is not a candidate for the study. Unwilling to sign the informed consent form.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomly assigned to one of two different protocols by a designated study team member based on a computer generated randomization table. Randomization will occur on the day of surgery. Randomization will be 1:1.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dosing of methadone<br>Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning. | Drug: Standard dosing of methadone<br>* Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.<br>|
| Experimental: Aliquots of methadone titrated to apnea<br>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. | Drug: Aliquots of methadone titrated to apnea<br>* Subjects will 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in opioid requirement for complex spine surgery patients | 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. | Changes from baseline (pre-op) up to 72 hours post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-operative pain, Spine surgery, Methadone, Opioid