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

• ClinicalTrials.gov Identifier: NCT04672252
• Recruitment Status: Completed
• First Posted: December 17, 2020
• Results First Posted: March 7, 2023
• Last Update Posted: March 7, 2023
• Sponsor: NYU Langone Health
• Collaborator: Orcosa Inc.
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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	Drug: CBD Oral Disintegrating Tablet (ODT); Other: Placebo ODT	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: December 16, 2021
• Actual Study Completion Date: December 16, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1 - CBD	Drug: CBD Oral Disintegrating Tablet (ODT); Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
Placebo Comparator: Cohort 2 - Placebo	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.

Outcome Measures

Primary Outcome Measures :

1. Pain Visual Analog Scale (VAS) Score [ Time Frame: Hour 24 Post-Surgery ]
   Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
2. Pain Visual Analog Scale (VAS) Score [ Time Frame: Day 2 Post-Surgery ]
   Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
3. Pain Visual Analog Scale (VAS) Score [ Time Frame: Day 7 Post-Surgery ]
   Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
4. Pain Visual Analog Scale (VAS) Score [ Time Frame: Day 14 Post-Surgery ]
   Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
5. Nausea Score on VAS Scale [ Time Frame: Day 2 Post-Surgery ]
   Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
6. Nausea Score on VAS Scale [ Time Frame: Day 7 Post-Surgery ]
   Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
7. Nausea Score on VAS Scale [ Time Frame: Day 14 Post-Surgery ]
   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. Total Opioid Consumption [ Time Frame: Day 1 Post-Surgery ]
   Consumption based on patient-self-report
2. Total Opioid Consumption [ Time Frame: Day 2 Post-Surgery ]
   Consumption based on patient-self-report.
3. Total Opioid Consumption [ Time Frame: Day 7 Post-Surgery ]
   Consumption based on patient-self-report.
4. Total Opioid Consumption [ Time Frame: Day 14 Post-Surgery ]
   Consumption based on patient-self-report.
5. Number of Completed Doses Out of 3 Maximum Doses/Day [ Time Frame: Day 1 Post-Surgery ]
   Based on patient-self-report.
6. Number of Completed Doses Out of 3 Maximum Doses/Day [ Time Frame: Day 7 Post-Surgery ]
   Based on patient-self-report.
7. Number of Completed Doses Out of 3 Maximum Doses/Day [ Time Frame: Day 14 Post-Surgery ]
   Based on patient-self-report.
8. Patient Satisfaction Score [ Time Frame: Hour 24 Post-Surgery ]
   Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
9. Patient Satisfaction Score [ Time Frame: Day 2 Post-Surgery ]
   Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
10. Patient Satisfaction Score [ Time Frame: Day 7 Post-Surgery ]
    Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
11. Patient Satisfaction Score [ Time Frame: Day 14 Post-Surgery ]
    Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, New York

NYU Langone Health

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

Orcosa Inc.

Investigators

• Principal Investigator: Michael Alaia, MD; NYU Langone Health

  Study Documents (Full-Text)

Documents provided by NYU Langone Health:

Study Protocol and Statistical Analysis Plan  [PDF] July 5, 2022

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Alaia MJ, Hurley ET, Vasavada K, Markus DH, Britton B, Gonzalez-Lomas G, Rokito AS, Jazrawi LM, Kaplan K. Buccally Absorbed Cannabidiol Shows Significantly Superior Pain Control and Improved Satisfaction Immediately After Arthroscopic Rotator Cuff Repair: A Placebo-Controlled, Double-Blinded, Randomized Trial. Am J Sports Med. 2022 Sep;50(11):3056-3063. doi: 10.1177/03635465221109573. Epub 2022 Jul 29.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04672252
• Other Study ID Numbers: 19-01293
• First Posted: December 17, 2020
• Results First Posted: March 7, 2023
• Last Update Posted: March 7, 2023
• Last Verified: February 2023

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)

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations