CBD Knee Scope Study (CBDS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: Cannabidiol Oil

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Deborah Warren, RN; Phone Number: 813-910-3688; Email: dwarren@foreonline.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute
      • Contact: Deborah Warren, RN; Phone Number: 813-910-3688; Email: dwarren@foreonline.org
      • Principal Investigator: Delbert Remaley, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Opioid standard of care: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days
Experimental: Cannabidiol Oil 100 mg/day; CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively	Drug: Cannabidiol Oil; Subjects will self administer CBD sublingually
Experimental: Cannabidiol Oil 200 mg/day; CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively.	Drug: Cannabidiol Oil; Subjects will self administer CBD sublingually

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain control	Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable.	30 days post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2023
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: USF006030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No