Methadone Versus Placebo in Spine Fusion

Postoperative Pain Clinical Trial

Official title: The Effect of Methadone on Perioperative Analgesia After Posterior Lumbar Fusion - A Randomized, Placebo-controlled, Double-blinded Study

Status Withdrawn

Clinical Trial 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?

Clinical Trial Description

Hypothesis:

1. We hypothesize that 0.2 mg/kg of methadone will result in decreased postoperative hydromorphone consumption compared to hydromorphone alone in opioid naïve patients or patients who are taking less than the equivalent of 15 mg IV morphine a day undergoing lumbar interbody fusion.

2. We hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

• NCT number: NCT01125059
• Study type: Interventional
• Source: Northwestern University
• Status: Withdrawn
• Phase: N/A
• Start date: May 2010
• Completion date: January 2014