Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery (CBDS)
Primary Purpose
Post-operative Pain
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol Oil
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain
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.
Sites / Locations
- Florida Orthopaedic InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Standard of Care
Cannabidiol Oil 100 mg
Cannabidiol Oil 200 mg
Arm Description
Opioid standard of care: Tramadol 50 mg PO PRN #30, Hydrocodone/Acetaminophen 5/325 PO PRN #30
CBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
CBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
Outcomes
Primary Outcome Measures
Post-operative pain
Numerical Pain Scale (NRS): 0 being no pain, 10 being the worst pain imaginable. Higher scores are worse outcomes.
Secondary Outcome Measures
Sleep Quality
Insomnia Severity Index
Full Information
NCT ID
NCT05240755
First Posted
February 2, 2022
Last Updated
April 12, 2023
Sponsor
Foundation for Orthopaedic Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT05240755
Brief Title
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery
Acronym
CBDS
Official Title
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
February 15, 2025 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Foundation for Orthopaedic Research and Education
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Opioid standard of care: Tramadol 50 mg PO PRN #30, Hydrocodone/Acetaminophen 5/325 PO PRN #30
Arm Title
Cannabidiol Oil 100 mg
Arm Type
Experimental
Arm Description
CBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
Arm Title
Cannabidiol Oil 200 mg
Arm Type
Experimental
Arm Description
CBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
Intervention Type
Drug
Intervention Name(s)
Cannabidiol Oil
Intervention Description
Subjects will self-administer CBD sublingually.
Primary Outcome Measure Information:
Title
Post-operative pain
Description
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 Outcome Measure Information:
Title
Sleep Quality
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael C Doarn, MD
Phone
8139789700
Email
mdoarn@floridaortho.com
First Name & Middle Initial & Last Name or Official Title & Degree
Debbi Warren
Phone
8139789700
Email
dwarren@foreonline.org
Facility Information:
Facility Name
Florida Orthopaedic Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33736
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbi Warren, RN
Phone
813-978-9700
Ext
6766
Email
dwarren@foreonline.org
First Name & Middle Initial & Last Name & Degree
Jason Nydick, MD
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery
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