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COMPLETED
NCT04749628
PHASE4

Cannabidiol for Bilateral Total Knee Arthroplasty

Sponsor: Hospital for Special Surgery, New York

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2022-11-02

Completion Date

2025-01-08

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

DRUG

cannabidiol

Epidiolex (cannabidiol) oral solution

OTHER

Ora-sweet SF

Ora-sweet SF placebo

Locations (1)

Hospital for Special Surgery

New York, New York, United States