Methadone Versus Placebo in Spine Fusion

Northwestern University

Overview

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?

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Postoperative Pain

Interventions

MethadoneDRUG

0.2 mg/kg methadone IV bolus

SalineDRUG

3 mL saline IV bolus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Hydromorphone postoperative opioid consumption (POC) at 48 hours

PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU

Time frame: 48 hrs

Secondary Outcomes

Intraoperative remifentanil consumption

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)

Time frame: the 8 hours prior to arrival in the recovery room

pain at rest and with movement (numerical Rating Scale, NRS)