CBD Knee Scope Study (CBDS)

September 22, 2026 updated by: Foundation for Orthopaedic Research and Education

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

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33637
        • Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 30 days post-operatively

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
Time Frame: 30 days preoperatively leading up to surgery, then 30 days postoperatively. Outcomes will be collected from surgery to 6 weeks postoperatively.

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

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Orthopaedic Research and Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 25, 2026

Last Update Submitted That Met QC Criteria

September 22, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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