Clinical trial NCT01125059: Methadone Versus Placebo in Spine Fusion
Official title: The Effect of Methadone on Perioperative Analgesia After Posterior Lumbar Fusion - A Randomized, Placebo-controlled, Double-blinded Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Pain
Keywords: hydromorphone
lumbar posterior spinal fusion
lumbosacral spondylosis
Spinal Fusion
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Northwestern University Feinberg School of Medicine
First posted: 2010-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hydromorphone postoperative opioid consumption (POC) at 48 hours
timeFrame: 48 hrs
Secondary outcomes:
measure: Intraoperative remifentanil consumption
timeFrame: the 8 hours prior to arrival in the recovery room
measure: pain at rest and with movement (numerical Rating Scale, NRS)
timeFrame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
measure: the level of sedation (modified Observer's Assessment of Alertness and Sedation Scale, modified OAA/S scale)
timeFrame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
measure: the number of occurrences of ventilatory depression during each evaluation interval
timeFrame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
measure: number of occurrences of nausea (resulting in treatment)
timeFrame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
measure: recorded emesis
timeFrame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
measure: occurrence of pruritus
timeFrame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
measure: Hydromorphone postoperative opioid consumption (POC)
timeFrame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Dhanesh K Gupta, M.D.
role: PRINCIPAL_INVESTIGATOR
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