CBD Knee Scope Study

Post-operative Pain Clinical Trial

— CBDS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05934500
• Other study ID #: USF006030
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: October 15, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2023
• Source: Foundation for Orthopaedic Research and Education
• Contact: Deborah Warren, RN
• Phone: 813-910-3688
• Email: dwarren[@]foreonline.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2025
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Cannabidiol Oil
Subjects will self administer CBD sublingually

Locations

Country	Name	City	State
United States	Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Orthopaedic Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain control	Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable.	30 days post-operatively
Secondary	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.