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

Early Phase 1CompletedNCT05240755

Foundation for Orthopaedic Research and Education40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post-operative Pain

Interventions

Cannabidiol OilDRUG

Subjects will self-administer CBD sublingually.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Florida Orthopaedic Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

Post-operative pain

Numerical Pain Scale (NRS): 0 being no pain, 10 being the worst pain imaginable. Higher scores are worse outcomes.

Time frame: 30 days post-operatively

Secondary Outcomes

Sleep Quality

Insomnia Severity Index

Time frame: 30 days preoperatively leading up to surgery then 30 days postoperatively as well. Outcomes will be collected from surgery to 6 weeks postoperatively.

Data from ClinicalTrials.gov

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