Status:
UNKNOWN
Dronabinol for Post-operative Pain After Lumbar Fusion
Lead Sponsor:
Jeffrey L Gum MD
Conditions:
Post-operative Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04346407
Start Date
September 1 2020
End Date
September 1 2023
Last Update
February 12 2021
Active Locations (1)
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1
Norton Healthcare
Louisville, Kentucky, United States, 40202