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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
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.
NYU Langone Health
New York, New York, United States
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Day 14 Post-Surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Total Opioid Consumption
Consumption based on patient-self-report
Time frame: Day 1 Post-Surgery
Total Opioid Consumption
Consumption based on patient-self-report.
Time frame: Day 2 Post-Surgery
Total Opioid Consumption
Consumption based on patient-self-report.
Time frame: Day 7 Post-Surgery
Total Opioid Consumption
Consumption based on patient-self-report.
Time frame: Day 14 Post-Surgery
Number of Completed Doses Out of 3 Maximum Doses/Day
Based on patient-self-report.
Time frame: Day 1 Post-Surgery
Number of Completed Doses Out of 3 Maximum Doses/Day
Based on patient-self-report.
Time frame: Day 7 Post-Surgery
Number of Completed Doses Out of 3 Maximum Doses/Day
Based on patient-self-report.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Day 14 Post-Surgery