Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Methadone Hydrochloride; Standard pain regimen; Spinal Fusion Surgery; Dexamethasone; Ketamine; Remifentanil; Sufentanil
Intervention description: IV administration of methadone intra-operatively for a single dose; Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine; Clinically-indicated spinal fusion surgery; Post operative swelling and pain control; Perioperative anesthesia medication; Perioperative pain medication; Perioperative pain medication
Intervention MeSH terms: Dexamethasone; Sufentanil; Ketamine; Remifentanil; Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets age criteria, age between 18-80

          -  Undergoing lumbar fusion surgery, one or two spinal levels

          -  ASA (American Society of Anesthesiologists) 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 (corrected QT interval) on pre-operative EKG,

          -  Refusal or inability to sign the consent form

          -  Current use of HIV-1 protease inhibitors, erythromycin, ketoconazole, rifabutin,
             carbamazepine, phenytoin, phenobarbital, St. John's Wort, fluconazole, fluvoxamine,
             fluoxetine, paroxetine

          -  Grapefruit juice intake within the last week