Methadone Versus Placebo in Spine Fusion

Northwestern University

Status

Withdrawn

Conditions

Postoperative Pain

Treatments

Drug: Saline

Drug: Methadone

Study type

Interventional

Funder types

Other

Identifiers

NCT01125059

STU00027431

Details and patient eligibility

About

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?

Full description

Hypothesis:

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

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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