Cannabidiol for Bilateral Total Knee Arthroplasty

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Treatments: Cannabidiol; Epidiolex

Criteria

Inclusion Criteria:

• Age 18 to 70

• 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)

• 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

• 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)

• Stress dose steroids