Status:
COMPLETED
Cannabidiol for Bilateral Total Knee Arthroplasty
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Pain, Postoperative
Opioid Use
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
In light of the opioid epidemic and evidence suggesting that cannabis may be opioid-sparing, we are in a unique position to conduct a novel, high-impact study that would set the stage for future RCTs ...
Eligibility Criteria
Inclusion
- Age 18 to 75
- Scheduled for same-day bilateral total knee replacements with participating surgeons
- American Society of Anesthesiologists (ASA) Physical Status 1 or 2
Exclusion
- ASA 3 and higher
- Weight \< 40kg
- Planned use of general anesthesia
- Contraindication to major components of study protocol
- Cannabis or cannabinoid use within the past 3 months (recreational and/or medical)
- Use or ingestion of hemp seeds or hemp oil in any form within the past 30 days
- Chronic opioid use (\>3 months)
- Coumadin use
- Current use of SSRI or SNRIs
- History of substance abuse or dependence
- Active or history of major psychiatric illness
- Severe cardiovascular disorder
- Severe hepatic or renal insufficiency (transaminase levels above ULN)
- History of epilepsy
- Diagnosis of rheumatic disease, autoimmune disease, or immunodeficiency (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, etc.)
- Use of valproate or clobazam
- Known or suspected hypersensitivity, allergy, or contraindication to cannabinoids or any of the excipients in the study medications (i.e. sesame oil, sucralose, strawberry flavor)
- Active use of steroids - oral steroids upon admission
- Stress dose steroids
- Non-English speakers
- Planned discharge to home without caregiver(s)
Key Trial Info
Start Date :
November 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04749628
Start Date
November 2 2022
End Date
January 8 2025
Last Update
February 6 2025
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021