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

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

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.

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