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

Early Phase 1

Completed

• Conditions: Post-operative Pain
• Interventions: Drug: Cannabidiol Oil

• Registration Number: NCT05240755
• Lead Sponsor: Foundation for Orthopaedic Research and Education

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-13
• Study First Posted: 2022-02-15
• Study Start: 2022-07-01
• Primary Completion: 2024-06-20
• Study Completion: 2024-08-20
• Status Verified: 2024-09
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cannabidiol Oil 100 mg	Cannabidiol Oil	CBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
Cannabidiol Oil 200 mg	Cannabidiol Oil	CBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op

Primary Outcome Measures

Name	Time	Method
Post-operative pain	30 days post-operatively	Numerical Pain Scale (NRS): 0 being no pain, 10 being the worst pain imaginable. Higher scores are worse outcomes.

Secondary Outcome Measures

Name	Time	Method
Sleep Quality	30 days preoperatively leading up to surgery then 30 days postoperatively as well. Outcomes will be collected from surgery to 6 weeks postoperatively.	Insomnia Severity Index

Trial Locations

Locations (1)

Florida Orthopaedic Institute; 🇺🇸 Tampa, Florida, United States