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

Pain, Postoperative Clinical Trial

Official title:

The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy; A Double-Blind, Randomized Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672252
• Other study ID #: 19-01293
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 1, 2020
• Est. completion date: December 16, 2022

Study information

• Verified date: February 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• CBD Oral Disintegrating Tablet (ODT)
Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Orcosa Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Hour 24 Post-Surgery
Primary	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).	Day 2 Post-Surgery
Primary	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).	Day 7 Post-Surgery
Primary	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).	Day 14 Post-Surgery
Primary	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).	Day 2 Post-Surgery
Primary	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).	Day 7 Post-Surgery
Primary	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).	Day 14 Post-Surgery
Secondary	Total Opioid Consumption	Consumption based on patient-self-report	Day 1 Post-Surgery
Secondary	Total Opioid Consumption	Consumption based on patient-self-report.	Day 2 Post-Surgery
Secondary	Total Opioid Consumption	Consumption based on patient-self-report.	Day 7 Post-Surgery
Secondary	Total Opioid Consumption	Consumption based on patient-self-report.	Day 14 Post-Surgery
Secondary	Number of Completed Doses Out of 3 Maximum Doses/Day	Based on patient-self-report.	Day 1 Post-Surgery
Secondary	Number of Completed Doses Out of 3 Maximum Doses/Day	Based on patient-self-report.	Day 7 Post-Surgery
Secondary	Number of Completed Doses Out of 3 Maximum Doses/Day	Based on patient-self-report.	Day 14 Post-Surgery
Secondary	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).	Hour 24 Post-Surgery
Secondary	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).	Day 2 Post-Surgery
Secondary	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).	Day 7 Post-Surgery
Secondary	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).	Day 14 Post-Surgery