Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Opioid standard of care: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days | |
| Cannabidiol Oil 100 mg/day | Experimental | CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively |
|
| Cannabidiol Oil 200 mg/day | Experimental | CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol Oil | Drug | Subjects will self administer CBD sublingually |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Warren, RN | Contact | 813-910-3688 | dwarren@foreonline.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute | Tampa | Florida | 33637 | United States |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |