NCT05934500

CBD Knee Scope Study

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Foundation for Orthopaedic Research and Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post-operative Pain

Interventions

Type	Name	Description
DRUG	Cannabidiol Oil	Subjects will self administer CBD sublingually

Timeline

• Start date: 2023-10-15
• Primary completion: 2025-07-15
• Completion: 2025-12-30
• First posted: 2023-07-07
• Last updated: 2023-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study