CBD Knee Scope Study

Study Overview
=================
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.

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.

Official Title
-----------------
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Knee Arthroscopic Surgery

Conditions
-----------------
Post-operative Pain

Intervention / Treatment
-----------------
* Drug: Cannabidiol Oil


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Opioid standard of care: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days | |
| Experimental: Cannabidiol Oil 100 mg/day<br>CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively | Drug: Cannabidiol Oil<br>* Subjects will self administer CBD sublingually<br>|
| Experimental: Cannabidiol Oil 200 mg/day<br>CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively. | Drug: Cannabidiol Oil<br>* Subjects will self administer CBD sublingually<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain control | Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable. | 30 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Insomnia Severity Index . | 30 days preoperatively leading up to surgery, then 30 days postoperatively. Outcomes will be collected from surgery to 6 weeks postoperatively. |