Cannabidiol for Knee Surgery Pain

Palo Alto (17 mi)

Overseen byAlexandra Sideris, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Hospital for Special Surgery, New York

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-75 scheduled for bilateral knee replacements who are generally healthy (ASA Physical Status 1 or 2). It's not for those with severe health issues, recent cannabis use, chronic opioid use, certain medication usage, or major psychiatric history.

Inclusion Criteria

I am scheduled for knee replacement surgery on both knees with approved surgeons.

I am in good or mild systemic disease state according to ASA.

I am between 18 and 75 years old.

Exclusion Criteria

I am taking Coumadin.

I have a history of or currently have a major psychiatric illness.

I am currently taking medication for depression or anxiety.

I have been diagnosed with a condition like rheumatoid arthritis or multiple sclerosis.

I do not speak English.

I am currently taking valproate or clobazam.

I am not allergic to cannabinoids, sesame oil, sucralose, or strawberry flavor.

I am allergic or cannot tolerate key parts of the study treatment.

I weigh less than 40kg.

I will be undergoing surgery with general anesthesia.

I am currently taking oral steroids.

I am taking high doses of steroids for stress.

I have a severe heart condition.

My liver or kidney function is severely impaired.

Treatment Details

The study tests Epidiolex®, an FDA-approved oral CBD solution. Participants will receive either a placebo, 400mg or 800mg of Epidiolex® to see if it reduces opioid need and pain after knee surgery while checking its safety and effects on body inflammation.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 800mg cannabidiolExperimental Treatment1 Intervention

Group II: 400mg cannabidiolExperimental Treatment1 Intervention

Group III: Ora-sweet SFPlacebo Group1 Intervention