Effects of Cannabidiol (CBD) Oral Solution in Patients Undergoing Bilateral Total Knee Arthroplasty: a Randomized, Controlled, Parallel, Triple Blind, Pilot Study

Who is this study for? Patients with Postoperative Pain, Knee Osteoarthritis, Opioid Use Disorder
Status: Completed
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Hospital for Special Surgery
New York
Time Frame
Start Date: 2022-11-02
Completion Date: 2025-01-08
Participants
Target number of participants: 37
Treatments
Placebo_comparator: Ora-sweet SF
Experimental: 400mg cannabidiol
Experimental: 800mg cannabidiol
Authors
Kethy M Jules-Elysee
Sponsors
Leads: Hospital for Special Surgery, New York

This content was sourced from clinicaltrials.gov