Methadone Versus Placebo in Spine Fusion

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Methadone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methadone Group<br>0.2 mg/kg IV methadone | Drug: Methadone<br>* 0.2 mg/kg methadone IV bolus<br>* Other names: Dolophine;|
| Placebo Comparator: Placebo Group<br>5 mL saline bolus | Drug: Saline<br>* 3 mL saline IV bolus<br>* Other names: 0.9 NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydromorphone postoperative opioid consumption (POC) at 48 hours | PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU | 48 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | the 8 hours prior to arrival in the recovery room | 
| pain at rest and with movement (numerical Rating Scale, NRS) |  | 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 | 
| the number of occurrences of ventilatory depression during each evaluation interval |  | 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 | 
| Hydromorphone postoperative opioid consumption (POC) | PCA opioid consumption at postoperative 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs after arriving in the PACU | 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydromorphone, lumbar posterior spinal fusion, lumbosacral spondylosis, Spinal Fusion