CBD Knee Scope Study (CBDS)

Foundation for Orthopaedic Research and Education

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Post-operative Pain

Treatments: Drug: Cannabidiol Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT05934500

USF006030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Standard of Care

No Intervention group

Description:

Opioid standard of care: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days

Cannabidiol Oil 100 mg/day

Experimental group

Description:

CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively

Treatment:

Drug: Cannabidiol Oil

Cannabidiol Oil 200 mg/day

Experimental group

Description:

CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively.

Treatment:

Drug: Cannabidiol Oil