Cannabidiol for Bilateral Total Knee Arthroplasty
Key facts
- Who runs it
- Hospital for Special Surgery, New York
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 37 people enrolled
- Started
- 2 Nov 2022
- Ended
- 8 Jan 2025
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- cannabidiol
- Ora-sweet SF
- Record updated
- 26 May 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- 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
Who cannot take part
- Active use of steroids - oral steroids upon admission
- Stress dose steroids
- History of substance abuse or dependence
- Active or history of major psychiatric illness
- Severe cardiovascular disorder
- History of epilepsy
- Diagnosis of rheumatic disease, autoimmune disease, or immunodeficiency (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, etc.)
- 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)
- Severe hepatic or renal insufficiency (transaminase levels above ULN)
- 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
- Use of valproate or clobazam
- Non-English speakers
- Planned discharge to home without caregiver(s)
Where in United States
- Hospital for Special SurgeryNew York, United StatesNo longer taking part
About the trial
What the trial wants to find out
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 examining the effects of a nonintoxicating and nonaddictive cannabinoid in an orthopedic patient population. Epidiolex®, an oral cannabidiol (CBD) solution, is the first ever cannabis-derived medication to be approved by the Food \& Drug Administration. Our aim is to conduct a pilot study using a placebo oral solution, 400mg and 800mg Epidiolex® to gather data on its effects on patients undergoing bilateral total knee arthroplasty (BTKA). We will be estimating whether Epidiolex® is associated with minimal opioid use and adequate analgesia. We will also assess its tolerability, pharmacokinetics, and effects on inflammatory markers in the perioperative setting.
The 3 groups in the trial
- Ora-sweet SFPlacebo, for comparison
- 400mg cannabidiolTreatment being tested
Treatment: cannabidiol
- 800mg cannabidiolTreatment being tested
Treatment: cannabidiol
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Cannabidiol (CBD) Oral Solution in Patients Undergoing Bilateral Total Knee Arthroplasty: a Randomized, Controlled, Parallel, Triple Blind, Pilot Study
- Record updated
- 26 May 2026