Dronabinol for Post-operative Pain After Lumbar Fusion
Overview
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
Full Title of Study: “Impact of Dronabinol on Post-operative Pain After Lumbar Fusion for Degenerative Disorders of the Spine”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: September 1, 2023
Detailed Description
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.
Interventions
- Drug: Dronabinol 2.5mg Cap
- 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
- Drug: Placebo
- Placebo capsule daily starting with pre-op cocktail and continued twice daily for three days after surgery
Arms, Groups and Cohorts
- Experimental: Dronabinol
- 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
- Placebo Comparator: Placebo
- Capsule with placebo daily starting with pre-op cocktail and continued twice daily for three days after surgery
Clinical Trial Outcome Measures
Primary Measures
- Cumulative Morphine Milligrams at 72 hours post-operative
- Time Frame: 72 hours post-operative
- Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery
Secondary Measures
- Cumulative Morphine Milligrams at 24 hours post-operative
- Time Frame: 24 hours post-operative
- Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery
- Cumulative Morphine Milligrams at 48 hours post-operative
- Time Frame: 48 hours post-operative
- Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery
- Worst pain in past 24 hours post-operative
- Time Frame: 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
- Worst pain in past 48 hours post-operative
- Time Frame: 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
- Worst pain in past 72 hours post-operative
- Time Frame: 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
Participating in This Clinical Trial
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)
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Jeffrey L Gum MD
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Jeffrey L Gum MD, Attending Spine Surgeon – Norton Leatherman Spine Center
- Overall Official(s)
- Jeffrey L Gum, MD, Principal Investigator, Norton Healthcare
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