Clinical trial

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

Name

USF003668

Description

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.

Trial arms

Trial start

2022-07-01

Estimated PCD

2025-02-15

Trial end

2025-12-15

Status

Recruiting

Phase

Early phase I

Treatment

Cannabidiol Oil

Subjects will self-administer CBD sublingually.

Arms:

Cannabidiol Oil 100 mg, Cannabidiol Oil 200 mg

Size

Primary endpoint

Post-operative pain

30 days post-operatively

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2023-04-13

1 organization

1 product

1 indication

Organization

Foundation for Orthopaedic Research and Education

Product

Cannabidiol

Indication

Postoperative Pain