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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05240755
Recruitment Status : Not yet recruiting
First Posted : February 15, 2022
Last Update Posted : July 28, 2022
Sponsor:
Information provided by (Responsible Party):
Michael C. Doarn, 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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: Cannabidiol Oil Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : February 15, 2023
Estimated Study Completion Date : February 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

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.




Primary Outcome Measures :
  1. Post-operative pain [ Time Frame: 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 :
  1. Sleep Quality [ 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. ]
    Insomnia Severity Index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05240755


Contacts
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Contact: Michael C Doarn, MD 8139789700 mdoarn@floridaortho.com
Contact: Debbi Warren 8139789700 dwarren@foreonline.org

Locations
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United States, Florida
Florida Orthopaedic Institute
Tampa, Florida, United States, 33736
Sponsors and Collaborators
Foundation for Orthopaedic Research and Education
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Responsible Party: Michael C. Doarn, Principal Investigator, Clinical Professor of Orthopaedic Surgery - USF, Foundation for Orthopaedic Research and Education
ClinicalTrials.gov Identifier: NCT05240755    
Other Study ID Numbers: USF003668
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Cannabidiol
Anticonvulsants