Cannabidiol for Bilateral Total Knee Arthroplasty

Completed · Phase 4 · Has a placebo group

Conditions studied: Pain, Postoperative, Opioid Use, Knee Osteoarthritis

In brief

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.

Key facts

Study ID

NCT04749628

Run by

Hospital for Special Surgery, New York

People needed

37

Starts

2022-11-02

Expected to finish

2025-01-08

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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