Cannabidiol for Knee Surgery Pain

Overseen By William Chan, MEng

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Cannabis, Opioids, SSRIs, SNRIs

Disqualifiers: Substance abuse, Psychiatric illness, Cardiovascular disorder, Hepatic insufficiency, Rheumatic disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 week

37 Participants Needed

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.

Research Team

Alexandra Sideris, PhD

Principal Investigator

Hospital for Special Surgery, New York

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.

Exclusion Criteria

I am taking Coumadin.

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

You have been using opioid pain medication for more than three months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 400mg or 800mg Epidiolex® or placebo during the perioperative period for bilateral total knee arthroplasty

1 week

Daily visits during hospital stay

Follow-up

Participants are monitored for safety, effectiveness, and various outcomes such as pain, anxiety, and sleep quality

3 months

Multiple visits including postoperative days 1, 2, 3, 4, 7, and at 3 months

Long-term follow-up

Participants' range of motion and other long-term outcomes are assessed

6 weeks

Visit at 6 weeks postoperatively

Treatment Details

Interventions

• cannabidiol

Trial Overview 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.

Participant Groups

Group I: 800mg cannabidiol Experimental Treatment 1 Intervention

Group II: 400mg cannabidiol Experimental Treatment 1 Intervention

Group III: Ora-sweet SF Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+