Cannabidiol for Bilateral Total Knee Arthroplasty

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative; Opioid Use; Knee Osteoarthritis

Treatments: Other: Ora-sweet SF; Drug: cannabidiol

Study type: Interventional

Funder types: Other

Identifiers

NCT04749628

2019-1688

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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37 participants in 3 patient groups, including a placebo group

Ora-sweet SF

Placebo Comparator group

Treatment:

Other: Ora-sweet SF

400mg cannabidiol

Experimental group

Treatment:

Drug: cannabidiol

800mg cannabidiol

Experimental group

Treatment:

Drug: cannabidiol