Cannabidiol for Bilateral Total Knee Arthroplasty (NCT04749628) | Clinical Trial Compass
CompletedPhase 4
Cannabidiol for Bilateral Total Knee Arthroplasty
United States37 participantsStarted 2022-11-02
Plain-language 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 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative Opioid Usage in First 72 Hours Postoperatively