Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749628
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2021-02-05
Brief Title:
Cannabidiol for Bilateral Total Knee Arthroplasty
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
Effects of Cannabidiol CBD Oral Solution in Patients Undergoing Bilateral Total Knee Arthroplasty a Randomized Controlled Parallel Triple Blind Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None