Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients

• Status: Completed
• Trial end date: 2020-11-10
• Target enrollment: 0
• Participant gender: All

Summary

Methadone has several advantages over standard narcotic medications, especially when considering use after a typically painful surgery such as lumbar fusion. Methadone is low cost, has a long half-life, has a convenient dosing schedule, has excellent oral bioavailability, and demonstrates slow onset to withdrawal. The literature comparing methadone to more commonly used post-operative narcotics demonstrates that it manages pain better, sustains consistent plasma concentrations, decreases overall narcotic requirement, results in no additional adverse events, and is safe, even in children, across several studies. Since the standard of care is non-methadone narcotic usage to manage the significant pain of complex spinal surgery cases, it is understandable that methadone could be a desirable alternative to promote sustained pain control and early ambulation in these patients. The goal of this study is to compare the effect of a single dose of methadone administered intraoperatively in enrolled spinal fusion patients to their historical controls given fentanyl and morphine, and determine if more sustained pain control during the first few days after surgery provides a better subjective experience for the patient with less pain, which allows them to ambulate and leave the hospital sooner than patients given a standard regimen.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Methadone

Criteria

Inclusion Criteria:

• Meets age criteria, age between 18-80

• Undergoing lumbar fusion surgery, one or two spinal levels

• ASA grades I-III

Exclusion Criteria:

• Patient outside of age criteria

• Renal failure requiring dialysis

• Serum creatinine greater than 2.0

• Hepatic dysfunction with liver function tests greater than twice the upper limit

• Pulmonary disease requiring home oxygen therapy

• Obstructive sleep apnea

• Severe heart disease

• Allergy to methadone, morphine, or fentanyl

• Recent or distant history of opioid abuse

• Poorly managed psychiatric illness

• Known history of alcohol abuse

• Morbid obesity (body mass index > 50 kg/m2)

• Treatment with other NMDA receptor antagonists

• Prolonged QTc on pre-operative EKG,

• Refusal or inability to sign the consent form

• Current use of HIV-1 protease inhibitors, erythromycin, ketoconazol, erifabutin, carbamazepine, phenytoin, phenobarbital, St. John's Wort, fluconazole, fluvoxamine, fluoxetine, paroxetine

• Grapefruit juice intake within the last week