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The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy

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: NCT04672252
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This study is designed to evaluate the effects of administering CBD to control post-operative pain in patients undergoing shoulder arthroscopy. Secondly, the purpose will be to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Other: CBD Oral Disintegrating Tablet (ODT) Other: Placebo ODT Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy; A Double-Blind, Randomized Control Study
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Experimental: Cohort 1 Other: CBD Oral Disintegrating Tablet (ODT)
Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen

Placebo Comparator: Cohort 2 Other: Placebo ODT

Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.

The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.





Primary Outcome Measures :
  1. Score on Pain Visual Analog Scale (VAS) [ Time Frame: 14 days ]
    Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable)

  2. Nauseau on VAS scale [ Time Frame: 14 days ]
    Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable)


Secondary Outcome Measures :
  1. CBD consumption [ Time Frame: Day 1, 7, 14 ]
    patient self report

  2. Opioid consumption [ Time Frame: Day 1, 7, 14 ]
    patient self report

  3. Patient Satisfaction [ Time Frame: Day 1, 7, 14 ]
    Patients will record their satisfaction with their management, on a 0-10 scale, 24 hours, 2 days and 7 days, and 14 days after surgery.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Patients undergoing an arthroscopic shoulder procedure (rotator cuff repair, decompression, labrum repair)
  • Patients ages 18-75, inclusive
  • Female patients must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly
  • Male patients must be using an effective form of contraception

Exclusion Criteria

  • Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
  • Younger than 18 years of age
  • Older than 75 years of age
  • Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners
  • History of cannabis abuse or dependence
  • History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values
  • History of stroke or acute coronary syndromes within 3 months before surgery
  • Abnormal coagulation profile
  • Renal failure (serum creatinine > 250 μmol/L [2.83 mg/dL]) or liver cirrhosis
  • Patients with a history of hypersensitivity to Percocet
  • Patients that have been on pre-operative opioid management for any reason
  • Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder
  • Patients diagnosed with major depression, psychosis, or substance abuse disorder
  • Patients with current or a history of suicidal ideation
  • Breastfeeding females
  • Patients with clinically significant illness, including cardiovascular disorders
  • Clinically significant lab abnormalities
  • Abnormal LFTs
  • Patients with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain/head injury, or seizures
  • Patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C).
  • Patients taking moderate or strong inhibitors of CYP3A4 and CYP2C19 (listed below) concomitantly
  • Patients taking strong CYP3A4 and CYP2C19 inducers (listed below) concomitantly
  • Patients taking substrates of UTG1A9, UTGB17, CYP2A1, CYP2B6, CYP2C8, CYP2C9 and CYP2C19 (listed below) concomitantly

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): NCT04672252


Contacts
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Contact: Michael Alaia, MD (646)-501-7223 michael.alaia@nyulangone.org
Contact: Eoghan Hurley, MD (646)-467-0851 eoghan.hurley@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Eoghan Hurley, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Michael Alaia, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04672252    
Other Study ID Numbers: 19-01293
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations