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

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 Overview

• Status: Recruiting
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: Cannabidiol Oil

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Michael C Doarn, MD; Phone Number: 8139789700; Email: mdoarn@floridaortho.com
• Study Contact Backup: Name: Debbi Warren; Phone Number: 8139789700; Email: dwarren@foreonline.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33736
      • Recruiting
      • Florida Orthopaedic Institute
      • Contact: Debbi Warren, RN; Phone Number: 6766 813-978-9700; Email: dwarren@foreonline.org
      • Principal Investigator: Jason Nydick, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Opioid standard of care: Tramadol 50 mg PO PRN #30, Hydrocodone/Acetaminophen 5/325 PO PRN #30
Experimental: Cannabidiol Oil 100 mg; CBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op	Drug: Cannabidiol Oil; Subjects will self-administer CBD sublingually.
Experimental: Cannabidiol Oil 200 mg; CBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op	Drug: Cannabidiol Oil; Subjects will self-administer CBD sublingually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): February 15, 2025
• Study Completion (Anticipated): December 15, 2025

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 13, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Estimate): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: USF003668

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No