CBD for Pain Reduction and Opioid Use After Ankle and Tibia Fracture ORIF

Ankle Fractures Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04768478
• Other study ID #: 21-00069
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Tibia Fracture
• Tibial Fractures

Intervention

Drug:
• CBD
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
• Placebo
Visually indistinguishable placebo ODTs, with instructions to take two tablets t.i.d., to be administered with routine post-operative pain management

Locations

Country	Name	City	State
United States	NYU Langone Orthopedic Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 2 Post-Surgery
Primary	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)	Day 7 Post-Surgery
Primary	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)	Day 14 Post-Surgery
Primary	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)	Day 2 Post-Surgery
Primary	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)	Day 7 Post-Surgery
Primary	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)	Day 14 Post-Surgery
Secondary	CBD Consumption	Patient self report	Day 2 Post-Surgery
Secondary	CBD Consumption	Patient self report	Day 7 Post-Surgery
Secondary	CBD Consumption	Patient self report	Day 14 Post-Surgery
Secondary	Opioid Consumption	Patient self report	Day 2 Post-Surgery
Secondary	Opioid Consumption	Patient self report	Day 7 Post-Surgery
Secondary	Opioid Consumption	Patient self report	Day 14 Post-Surgery
Secondary	Patient Satisfaction Score	Patients will record their satisfaction with their management, on a 0-10 scale. The higher the score, the higher the satisfaction.	Day 14 Post-Surgery