Ankle Fractures, Tibia Fracture
Conditions
Keywords
Cannabidiol
Brief summary
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.
Interventions
DRUGCBD
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
DRUGPlacebo
Visually indistinguishable placebo ODTs, with instructions to take two tablets t.i.d., to be administered with routine post-operative pain management
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing an ankle fracture open reduction and internal fixation (medial malleolus, lateral malleolus, posterior malleolus, and/or syndesmosis repair), tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation and intramedullary nail fixation), or tibial plateau open reduction and internal fixation * 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 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 concomitantly * Patients taking strong CYP3A4 and CYP2C19 inducers concomitantly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on Pain Visual Analog Scale (VAS) | Day 2 Post-Surgery | 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) |
| Level of Nausea Using VAS | Day 2 Post-Surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CBD Consumption | Day 2 Post-Surgery | Patient self report |
| Opioid Consumption | Day 2 Post-Surgery | Patient self report |
| Patient Satisfaction Score | Day 14 Post-Surgery | Patients will record their satisfaction with their management, on a 0-10 scale. The higher the score, the higher the satisfaction. |
Countries
United States
Outcome results
None listed