The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy

• Status: Enrolling by invitation
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research is to determine the pain-reducing effects of ketamine (Ketalar, an FDA-approved drug for anesthesia) and methadone (Dolophine, a long-acting narcotic) after lumbar laminectomy. The investigators would like to evaluate whether intraoperative use of both drugs may be able to provide better control of pain after lumbar surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: Ketamine; Methadone

Criteria

Inclusion Criteria:

• 18 - 80 years old of either gender, scheduled for elective lumbar laminectomy

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) IV and above

• Intolerance, allergy, or contraindication to use of any medications used in this study

• Significant coronary artery disease (abnormal stress test, myocardial infarction

• within the last 3 months)

• Increased intraocular pressure (e.g., untreated glaucoma)

• Uncontrolled hypertension (BP > 140/90)

• Sleep apnea and currently on continuous positive airway pressure (CPAP)

• Increased intracranial pressure or clinical signs thereof

• History of intracranial surgery, stroke, or brain aneurysm

• Cardiac arrhythmias particularly prolonged QT syndrome

• Drugs known to cause prolonged qT: class (IA) antiarrhythmics (quinidine, procainamide, disopyramide), class III antiarrhythmics (sotalol, dofetilide, ibutilide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants

• Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis

• Pregnant or lactating women

• Emergent laminectomy

• Those already receiving ketamine or methadone prior to surgery

• Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg

• Chronic renal failure ( creatinine > 2.0 mg/dL)

• Liver failure e.g., active cirrhosis

• Alcohol or substance abuse within in the past 3 months

• Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)

• Chronic obstructive pulmonary disease (COPD)/Hypercarbia

• Restrictive lung disease (pulmonary fibrosis, myasthenia gravis)

• Congestive heart failure

• Thyroid disease

• Organ transplant patients

• Drugs/substances known to inhibit methadone metabolism: macrolide antibiotics e.g., erythromycin, cimetidine, astemizole, voriconazole, grapefruit juice