Post-operative Pain
Conditions
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.
Interventions
DRUGCannabidiol Oil
Subjects will self administer CBD sublingually
Sponsors
Foundation for Orthopaedic Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain control | 30 days post-operatively | Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 . |
Countries
United States
Contacts
Primary ContactDeborah Warren, RN
Outcome results
None listed