CBD Knee Scope Study
CBDS
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Knee Arthroscopic Surgery
1 other identifier
interventional
100
1 country
1
Brief Summary
This is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications after a knee arthroscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 postoperative-pain
Started Oct 2023
Longer than P75 for early_phase_1 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedStudy Start
First participant enrolled
October 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedSeptember 13, 2023
September 1, 2023
1.8 years
June 28, 2023
September 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative pain control
Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable.
30 days post-operatively
Secondary Outcomes (1)
Sleep Quality
30 days preoperatively leading up to surgery, then 30 days postoperatively. Outcomes will be collected from surgery to 6 weeks postoperatively.
Study Arms (3)
Standard of Care
NO INTERVENTIONOpioid standard of care: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days
Cannabidiol Oil 100 mg/day
EXPERIMENTALCDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively
Cannabidiol Oil 200 mg/day
EXPERIMENTALCBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively.
Interventions
Subjects will self administer CBD sublingually
Eligibility Criteria
You may qualify if:
- Age 18 or older
- requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury
- able to complete surveys and follow-up visits
You may not qualify if:
- younger than 18 years of age
- history of knee dislocation, fracture, previous surgery, coexisting extremity pathology, \*pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute
Tampa, Florida, 33637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2023
First Posted
July 7, 2023
Study Start
October 15, 2023
Primary Completion
July 15, 2025
Study Completion
December 30, 2025
Last Updated
September 13, 2023
Record last verified: 2023-09