Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery

Study Overview
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Brief Summary
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The researchers are doing this study to find out whether giving methadone during spinal surgery helps manage pain in the first 72 hours after surgery better than other standard pain medications. Participants' pain will be measured by how much pain is reported after surgery, and how much additional pain medication is needed to lower pain levels. The researchers will look at whether giving methadone during surgery reduces the need for other pain medications after surgery. In addition, the team will compare the effects of methadone with the effects of a placebo to evaluate which one works best.

Official Title
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Modulation of Post-operative Opioid Consumption and Pain by Intraoperative Methadone for Cancer Related Spinal Surgery - An Investigator Initiated Trial (IIT), Double-Blind, Placebo-Controlled Trial

Conditions
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Spinal Surgery

Intervention / Treatment
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* Drug: Methadone
* Other: Saline placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (between 18-75 years of age) scheduled for extradural spine surgery with instrumentation (greater than or equal to two levels and including minimally invasive) of expected duration ≥ 2 hours Postoperative hospital stay expected to be ≥ 2 nights at the time of consent Exclusion Criteria: Use of methadone currently or within the previous 6 weeks Drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine, methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin). Current use of opioid antagonist/partial antagonist (i.e. buprenorphine). Current or past diagnosis of a Major Psychiatric disorder (such as Schizophrenia, dementia, delirium). Patients with a BMI ≥ 36 kg/m2 2nd or 3rd degree heart block as assessed by preoperative EKG. QTc > 450 msec on preoperative EKG. Documentation of congestive heart failure and/or ejection fraction < 30% if recorded in the Pre-Operative Record. Contraindication to use of any analgesic medications listed in the ERAS pathways (acetaminophen, gabapentin, celecoxib, IV opioids). Any known hypersensitivity to methadone. Pregnant or breastfeeding. Abnormal liver function tests as related to the MSK guidelines for use of IV acetaminophen: ALT greater than 2 x Upper Limit of Normal (> 75 U/L) Serum Creatinine > 1.5 mg/dl Instrumented spine cases of less than 2 levels All non-instrumented spine cases All intradural tumor resections All take backs that occur within 72 hours of surgery (wound revisions, hematomas, etc.)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methadone bolus<br>Patients will be administered methadone 0.2 mg/kg IV. | Drug: Methadone<br>* methadone 0.2 mg/kg IV.<br>|
| Placebo Comparator: Saline placebo<br>Patients will be administered 0.2 mg/kg IV of saline placebo. | Other: Saline placebo<br>* Saline placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid requirement in morphine equivalent | To see if giving methadone during surgery reduces the need for other pain medications after surgery | within 72 hours post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methadone, Pain Levels, Pain Medications, 22-015