Methadone Versus Placebo in Spine Fusion

• Status: Withdrawn
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

What is the influence of methadone on postoperative analgesia after lumbar interbody fusion in opioid naïve patients or patients who are taking less than equivalent of 15 mg IV morphine each day? What is the incidence of opioid related postoperative side effects after the administration of methadone in the operating room?

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Feinberg School of Medicine, Northwestern University
• Treatments: Methadone

Criteria

Inclusion Criteria:

• ASA physical status I, II, and III, male and non-pregnant female

• English-speaking patients

• Ages 18-75 years

• Undergoing elective one or two level posterior lumbar interbody fusion

Exclusion Criteria:

• Use of more than the equivalent of 15 mg of IV morphine/24 hr in the past 2 weeks.

• Use of drugs within the past 6 months that effect the pharmacokinetics or pharmacodynamics of opioids (i.e., benzodiazepines, anti-retroviral agents, rifampin, ketoconazole, erythromycin, or phenytoin).

• history of substance abuse at any time in the past

• known QT prolongation

• Non-elective operations (i.e., cancer or trauma)

• severe hepatic impairment (serum albumin < 3.0 g/dL in the presence of a history of liver disease)

• pregnancy

• inability to operate a patient-controlled analgesia device