CBD Knee Scope Study

Early Phase 1

Not yet recruiting

• Conditions: Post-operative Pain
• Interventions: Drug: Cannabidiol Oil

• Registration Number: NCT05934500
• Lead Sponsor: Foundation for Orthopaedic Research and Education

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.

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Study Start: 2023-10-15
• Primary Completion: 2025-07-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cannabidiol Oil 100 mg/day	Cannabidiol Oil	CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively
Cannabidiol Oil 200 mg/day	Cannabidiol Oil	CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 .

Trial Locations

Locations (1)

Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute; 🇺🇸 Tampa, Florida, United States