Clinical trial NCT04768478: CBD for Pain Reduction and Opioid Use After Ankle and Tibia Fracture ORIF
Official title: The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Ankle and Tibia Fracture Open Reduction and Internal Fixation. A Double-Blind, Randomized Control Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Ankle Fractures
Tibia Fracture
Keywords: Cannabidiol
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Score on Pain Visual Analog Scale (VAS)
timeFrame: Day 2 Post-Surgery
measure: Score on Pain Visual Analog Scale (VAS)
timeFrame: Day 7 Post-Surgery
measure: Score on Pain Visual Analog Scale (VAS)
timeFrame: Day 14 Post-Surgery
measure: Level of Nausea Using VAS
timeFrame: Day 2 Post-Surgery
measure: Level of Nausea Using VAS
timeFrame: Day 7 Post-Surgery
measure: Level of Nausea Using VAS
timeFrame: Day 14 Post-Surgery
Secondary outcomes:
measure: CBD Consumption
timeFrame: Day 2 Post-Surgery
measure: CBD Consumption
timeFrame: Day 7 Post-Surgery
measure: CBD Consumption
timeFrame: Day 14 Post-Surgery
measure: Opioid Consumption
timeFrame: Day 2 Post-Surgery
measure: Opioid Consumption
timeFrame: Day 7 Post-Surgery
measure: Opioid Consumption
timeFrame: Day 14 Post-Surgery
measure: Patient Satisfaction Score
timeFrame: Day 14 Post-Surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Orthopedic Hospital
state: New York
Study officials:
affiliation: NYU Langone Health
name: Philipp Leucht, MD
role: PRINCIPAL_INVESTIGATOR
References: