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NCT05240755 Clinical Trial

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

Post-operative Pain Clinical Trial

— CBDS  

Official title:
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05240755
Other study ID # USF003668
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date July 1, 2022
Est. completion date December 15, 2025

Study information
Verified date April 2023
Source Foundation for Orthopaedic Research and Education
Contact Michael C Doarn, MD
Phone 8139789700
Email mdoarn@floridaortho.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 15, 2025
Est. primary completion date February 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years or older - Requiring shoulder arthroscopic surgery for soft tissue pathology - Able to complete surveys and follow-up visits Exclusion Criteria: - Younger than 18 years of age - Shoulder dislocation, fracture, previous surgery, coexisting extremity pathology, pregnancy.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cannabidiol Oil
Subjects will self-administer CBD sublingually.

Locations
Country Name City State
United States Florida Orthopaedic 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 Numerical Pain Scale (NRS): 0 being no pain, 10 being the worst pain imaginable. Higher scores are worse outcomes. 30 days post-operatively
Secondary Sleep Quality Insomnia Severity Index 30 days preoperatively leading up to surgery then 30 days postoperatively as well. Outcomes will be collected from surgery to 6 weeks postoperatively.
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