Methadone Versus Placebo in Spine Fusion

Not Applicable

Withdrawn

• Conditions: Postoperative Pain
• Interventions: Drug: Saline; Drug: Methadone

• Registration Number: NCT01125059
• Lead Sponsor: Northwestern University

Brief 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?

Detailed 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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo Group	Saline	5 mL saline bolus
Methadone Group	Methadone	0.2 mg/kg IV methadone

Primary Outcome Measures

Name	Time	Method
Hydromorphone postoperative opioid consumption (POC) at 48 hours	48 hrs	PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU

Secondary Outcome Measures

Name	Time	Method
pain at rest and with movement (numerical Rating Scale, NRS)	1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
number of occurrences of nausea (resulting in treatment)	1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
recorded emesis	1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
occurrence of pruritus	1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
the level of sedation (modified Observer's Assessment of Alertness and Sedation Scale, modified OAA/S scale)	1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
Hydromorphone postoperative opioid consumption (POC)	1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs	PCA opioid consumption at postoperative 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs after arriving in the PACU
Intraoperative remifentanil consumption	the 8 hours prior to arrival in the recovery room	intraoperative consumption of remifentanil--the amount of remifentanil used in the OR (i.e., the 2-8 hours prior to arrival in the recovery room)
the number of occurrences of ventilatory depression during each evaluation interval	1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States