The purpose of this study is to evaluate the effects of administering CBD to control post-operative pain in patients undergoing ankle fracture open reduction and internal fixation, tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation or intramedullary nail fixation), or tibial plateau open reduction and internal fixation. Secondly, the purpose is to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
25mg CBD ODTs (orally disintegrating tablet), with instructions to take CBD tablets t.i.d. (total of 50mg per dose t.i.d.) to be administered with routine post-operative pain management
Visually indistinguishable placebo ODTs, with instructions to take two tablets t.i.d., to be administered with routine post-operative pain management
NYU Langone Orthopedic Hospital
New York, New York, United States
Score on Pain Visual Analog Scale (VAS)
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)
Time frame: Day 2 Post-Surgery
Score on Pain Visual Analog Scale (VAS)
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)
Time frame: Day 7 Post-Surgery
Score on Pain Visual Analog Scale (VAS)
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)
Time frame: Day 14 Post-Surgery
Level of Nausea Using VAS
Any nausea experienced by the patients will be recorded by use of a VAS (total range = 0-10; 0 = no nausea, 10 = worst nausea imaginable)
Time frame: Day 2 Post-Surgery
Level of Nausea Using VAS
Any nausea experienced by the patients will be recorded by use of a VAS (total range = 0-10; 0 = no nausea, 10 = worst nausea imaginable)
Time frame: Day 7 Post-Surgery
Level of Nausea Using VAS
Any nausea experienced by the patients will be recorded by use of a VAS (total range = 0-10; 0 = no nausea, 10 = worst nausea imaginable)
Time frame: Day 14 Post-Surgery
CBD Consumption
Patient self report
Time frame: Day 2 Post-Surgery
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CBD Consumption
Patient self report
Time frame: Day 7 Post-Surgery
CBD Consumption
Patient self report
Time frame: Day 14 Post-Surgery
Opioid Consumption
Patient self report
Time frame: Day 2 Post-Surgery
Opioid Consumption
Patient self report
Time frame: Day 7 Post-Surgery
Opioid Consumption
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. The higher the score, the higher the satisfaction.
Time frame: Day 14 Post-Surgery