Back to resultsThe Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CBD Oral Disintegrating Tablet (ODT)
Placebo ODT
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility 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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cohort 1 - CBD
Cohort 2 - Placebo
Arm Description
Outcomes
Primary Outcome Measures
Pain Visual Analog Scale (VAS) Score
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Pain Visual Analog Scale (VAS) Score
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Pain Visual Analog Scale (VAS) Score
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Pain Visual Analog Scale (VAS) Score
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Nausea Score on VAS Scale
Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Nausea Score on VAS Scale
Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Nausea Score on VAS Scale
Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Secondary Outcome Measures
Total Opioid Consumption
Consumption based on patient-self-report
Total Opioid Consumption
Consumption based on patient-self-report.
Total Opioid Consumption
Consumption based on patient-self-report.
Total Opioid Consumption
Consumption based on patient-self-report.
Number of Completed Doses Out of 3 Maximum Doses/Day
Based on patient-self-report.
Number of Completed Doses Out of 3 Maximum Doses/Day
Based on patient-self-report.
Number of Completed Doses Out of 3 Maximum Doses/Day
Based on patient-self-report.
Patient Satisfaction Score
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Patient Satisfaction Score
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Patient Satisfaction Score
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Patient Satisfaction Score
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Full Information
NCT ID
NCT04672252
First Posted
November 23, 2020
Last Updated
February 7, 2023
Sponsor
NYU Langone Health
Collaborators
Orcosa Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04672252
Brief Title
The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy
Official Title
The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy; A Double-Blind, Randomized Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
December 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Orcosa Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 - CBD
Arm Type
Experimental
Arm Title
Cohort 2 - Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CBD Oral Disintegrating Tablet (ODT)
Intervention Description
Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
Intervention Type
Other
Intervention Name(s)
Placebo ODT
Intervention Description
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 Measure Information:
Title
Pain Visual Analog Scale (VAS) Score
Description
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Time Frame
Hour 24 Post-Surgery
Title
Pain Visual Analog Scale (VAS) Score
Description
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Time Frame
Day 2 Post-Surgery
Title
Pain Visual Analog Scale (VAS) Score
Description
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Time Frame
Day 7 Post-Surgery
Title
Pain Visual Analog Scale (VAS) Score
Description
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Time Frame
Day 14 Post-Surgery
Title
Nausea Score on VAS Scale
Description
Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Time Frame
Day 2 Post-Surgery
Title
Nausea Score on VAS Scale
Description
Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Time Frame
Day 7 Post-Surgery
Title
Nausea Score on VAS Scale
Description
Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Time Frame
Day 14 Post-Surgery
Secondary Outcome Measure Information:
Title
Total Opioid Consumption
Description
Consumption based on patient-self-report
Time Frame
Day 1 Post-Surgery
Title
Total Opioid Consumption
Description
Consumption based on patient-self-report.
Time Frame
Day 2 Post-Surgery
Title
Total Opioid Consumption
Description
Consumption based on patient-self-report.
Time Frame
Day 7 Post-Surgery
Title
Total Opioid Consumption
Description
Consumption based on patient-self-report.
Time Frame
Day 14 Post-Surgery
Title
Number of Completed Doses Out of 3 Maximum Doses/Day
Description
Based on patient-self-report.
Time Frame
Day 1 Post-Surgery
Title
Number of Completed Doses Out of 3 Maximum Doses/Day
Description
Based on patient-self-report.
Time Frame
Day 7 Post-Surgery
Title
Number of Completed Doses Out of 3 Maximum Doses/Day
Description
Based on patient-self-report.
Time Frame
Day 14 Post-Surgery
Title
Patient Satisfaction Score
Description
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Time Frame
Hour 24 Post-Surgery
Title
Patient Satisfaction Score
Description
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Time Frame
Day 2 Post-Surgery
Title
Patient Satisfaction Score
Description
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Time Frame
Day 7 Post-Surgery
Title
Patient Satisfaction Score
Description
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Time Frame
Day 14 Post-Surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Alaia, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35905305
Citation
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.
Results Reference
derived
Learn more about this trial
The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy
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