NYU Langone Health
New York, 10016, United States
NCT Number: NCT04672252
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2 / Phase 3
New York, 10016, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Hour 24 Post-Surgery
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 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 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
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
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
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
Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Time frame: Day 1 Post-Surgery
Consumption based on patient-self-report
Time frame: Day 2 Post-Surgery
Consumption based on patient-self-report.
Time frame: Day 7 Post-Surgery
Consumption based on patient-self-report.
Time frame: Day 14 Post-Surgery
Consumption based on patient-self-report.
Time frame: Day 1 Post-Surgery
Based on patient-self-report.
Time frame: Day 7 Post-Surgery
Based on patient-self-report.
Time frame: Day 14 Post-Surgery
Based on patient-self-report.
Time frame: Hour 24 Post-Surgery
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
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
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
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
NYU Langone Health
Other
The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy; A Double-Blind, Randomized Control Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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