Status:
WITHDRAWN
CBD for Pain Reduction and Opioid Use After Ankle and Tibia Fracture ORIF
Lead Sponsor:
NYU Langone Health
Conditions:
Ankle Fractures
Tibia Fracture
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 (pil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04768478
Start Date
October 1 2021
End Date
December 31 2023
Last Update
January 28 2022
Active Locations (1)
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1
NYU Langone Orthopedic Hospital
New York, New York, United States, 10010