CBDS: CBD Knee Scope Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
This is a prospective non-blinded randomized controlled trial with 3 groups of subjects all undergoing knee arthroscopy for soft tissue pathology. The first group will receive the SOC opioid course: 7 days of Percocet (oxycodone 5mg-acetaminophen 325mg) every four hours PO PRN, following surgery. the second 100 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively, and the third group 200 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively.
All subjects in each of the three groups will undergo standard pre-operative and post-operative care, including physical exams, imaging, and education. They will only differ in pre-operative pain medication administration if they are in one of the two CBD groups. The groups will undergo surveys (sleep quality, self-reported pain, need for refill or switch to opioids). Sleep quality will be assessed with the Insomnia Severity Index (ISI) while pain, need for refill, and switch to opioids will be recorded by the patient on CRF packets. The CRF packets will be given to patients at each visit for them to fill out to the best of their ability.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard of Care Opioid standard of care: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days |
|
| Experimental: Cannabidiol Oil 100 mg/day CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively |
Drug: Cannabidiol Oil
Subjects will self administer CBD sublingually
|
| Experimental: Cannabidiol Oil 200 mg/day CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively. |
Drug: Cannabidiol Oil
Subjects will self administer CBD sublingually
|
Outcome Measures
Primary Outcome Measures
- Post-operative pain control [30 days post-operatively]
Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable.
Secondary Outcome Measures
- Sleep Quality [30 days preoperatively leading up to surgery, then 30 days postoperatively. Outcomes will be collected from surgery to 6 weeks postoperatively.]
Insomnia Severity Index .
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 or older
-
requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury
-
able to complete surveys and follow-up visits
Exclusion Criteria:
-
younger than 18 years of age
-
history of knee dislocation, fracture, previous surgery, coexisting extremity pathology, *pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute | Tampa | Florida | United States | 33637 |
Sponsors and Collaborators
- Foundation for Orthopaedic Research and Education
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- USF006030