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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: CBD Oral Disintegrating Tablet (ODT)
* Other: Placebo ODT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 - CBD<br> | Drug: CBD Oral Disintegrating Tablet (ODT)<br>* Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen<br>|
| Placebo Comparator: Cohort 2 - Placebo<br> | Other: Placebo ODT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption | Consumption based on patient-self-report | Day 1 Post-Surgery | 
| Total Opioid Consumption | Consumption based on patient-self-report. | Day 2 Post-Surgery | 
| Total Opioid Consumption | Consumption based on patient-self-report. | Day 7 Post-Surgery | 
| Total Opioid Consumption | Consumption based on patient-self-report. | Day 14 Post-Surgery | 
| Number of Completed Doses Out of 3 Maximum Doses/Day | Based on patient-self-report. | Day 1 Post-Surgery | 
| Number of Completed Doses Out of 3 Maximum Doses/Day | Based on patient-self-report. | Day 7 Post-Surgery | 
| Number of Completed Doses Out of 3 Maximum Doses/Day | Based on patient-self-report. | Day 14 Post-Surgery | 
| 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 | 
| 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 | 
| 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 | 
| 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 |