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NCT Number: NCT05934500

CBD Knee Scope Study

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.

Why the study stopped: insufficient drug supply at the time.
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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute

Tampa, Florida, 33637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabidiol Oil

Drug

Subjects will self administer CBD sublingually

Primary outcomes

  1. Post-operative pain control

    Time frame: 30 days post-operatively

    Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable.

Secondary outcomes

  1. 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 .

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Foundation for Orthopaedic Research and Education

Other

Registry information

Official study title

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

Acronym: CBDS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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