Dronabinol for Post-operative Pain After Lumbar Fusion

Study Overview
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Brief Summary
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Impact of 2.5mg of oral Dronabinol daily versus placebo on post-operative opioid consumption on patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion

Detailed Description
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This is a randomized double-blind clinical trial comparing 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery versus placebo for patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion. The outcome of interest is post-operative opioid consumption defined as cumulative Morphine Milligram Equivalents at 72 hours after surgery.

Official Title
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Impact of Dronabinol on Post-operative Pain After Lumbar Fusion for Degenerative Disorders of the Spine

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: Dronabinol 2.5mg Cap
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 65 years old Patients undergoing 1 to 3 level posterolateral fusion Opioid naïve or not No prior spine fusion Willing and able to sign an Informed Consent Exclusion Criteria: Indication for surgery is fracture, tumor or infection Comorbid psychiatric diagnosis requiring therapy and/or medication Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia) Has hepatic disease On workers compensation/disability/litigation Known adverse reaction to medications to be administered History of alcohol and drug abuse On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Interventional Model Description: Double-blind Placebo controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dronabinol<br>2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery | Drug: Dronabinol 2.5mg Cap<br>* 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery<br>* Other names: Syndros;|
| Placebo Comparator: Placebo<br>Capsule with placebo daily starting with pre-op cocktail and continued twice daily for three days after surgery | Drug: Placebo<br>* Placebo capsule daily starting with pre-op cocktail and continued twice daily for three days after surgery<br>* Other names: Placebo capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Morphine Milligrams at 72 hours post-operative | Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery | 72 hours post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Morphine Milligrams at 24 hours post-operative | Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery | 24 hours post-operative | 
| Cumulative Morphine Milligrams at 48 hours post-operative | Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery | 48 hours post-operative | 
| Worst pain in past 24 hours post-operative | Worst pain in past 24 hours post-op on a scale of 0 to 10, with 0 as no pain and 10 as worst pain imaginable | 24 hours post-operative | 
| Worst pain in past 48 hours post-operative | Worst pain in past 48 hours post-op on a scale of 0 to 10, with 0 as no pain and 10 as worst pain imaginable | 48 hours post-operative | 
| Worst pain in past 72 hours post-operative | Worst pain in past 72 hours post-op on a scale of 0 to 10, with 0 as no pain and 10 as worst pain imaginable | 72 hours post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Fusion, Post-operative Opioid Consumption, Post-operative Pain