Phase 3
N=100
The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT04672252 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Pain Visual Analog Scale (VAS) Score — 4.4; 5.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CBD Oral Disintegrating Tablet (ODT) (Drug); Placebo ODT (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Visual Analog Scale (VAS) Score |
1.6; 2.3 | — |
| PRIMARY Pain Visual Analog Scale (VAS) Score |
1.6; 2.3 | — |
| PRIMARY Pain Visual Analog Scale (VAS) Score |
1.6; 2.3 | — |
| PRIMARY Pain Visual Analog Scale (VAS) Score |
1.6; 2.3 | — |
| PRIMARY Nausea Score on VAS Scale |
0.1; 0.5 | — |
| PRIMARY Nausea Score on VAS Scale |
0.1; 0.5 | — |
| PRIMARY Nausea Score on VAS Scale |
0.1; 0.5 | — |
| SECONDARY Total Opioid Consumption |
8; 10.3 | — |
| SECONDARY Total Opioid Consumption |
8; 10.3 | — |
| SECONDARY Total Opioid Consumption |
8; 10.3 | — |
| SECONDARY Total Opioid Consumption |
8; 10.3 | — |
| SECONDARY Number of Completed Doses Out of 3 Maximum Doses/Day |
2.8; 2.7 | — |
| SECONDARY Number of Completed Doses Out of 3 Maximum Doses/Day |
2.8; 2.7 | — |
| SECONDARY Number of Completed Doses Out of 3 Maximum Doses/Day |
2.8; 2.7 | — |
| SECONDARY Patient Satisfaction Score |
8.7; 8.5 | — |
| SECONDARY Patient Satisfaction Score |
8.7; 8.5 | — |
| SECONDARY Patient Satisfaction Score |
8.7; 8.5 | — |
| SECONDARY Patient Satisfaction Score |
8.7; 8.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04672252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.