Methadone Versus Placebo in Spine Fusion

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Postoperative Pain

In brief

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?

Key facts

Study ID

NCT01125059

Run by

Northwestern University

People needed

0

Starts

2010-05-01

Expected to finish

2014-01-01

Last updated by the study team

2015-04-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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