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

Primary Purpose

Ankle Fractures, Tibia Fracture

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

CBD

Placebo

About this trial

This is an interventional treatment trial for Ankle Fractures focused on measuring Cannabidiol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NYU Langone Orthopedic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cannabidiol (CBD)

Control

Arm Description

Outcomes

Primary Outcome Measures

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)

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)

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)

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)

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)

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)

Secondary Outcome Measures

CBD Consumption

Patient self report

CBD Consumption

Patient self report

CBD Consumption

Patient self report

Opioid Consumption

Patient self report

Opioid Consumption

Patient self report

Opioid Consumption

Patient self report

Patient Satisfaction Score

Patients will record their satisfaction with their management, on a 0-10 scale. The higher the score, the higher the satisfaction.

Full Information

NCT ID

NCT04768478

First Posted

February 22, 2021

Last Updated

January 18, 2022

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT04768478

Brief Title

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Withdrawn

Why Stopped

there was no funding to begin the study

Study Start Date

October 1, 2021 (Anticipated)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Fractures, Tibia Fracture

Keywords

Cannabidiol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cannabidiol (CBD)

Arm Type

Active Comparator

Arm Title

Control

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

CBD

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Score on Pain Visual Analog Scale (VAS)

Description

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

Title

Score on Pain Visual Analog Scale (VAS)

Description

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

Title

Score on Pain Visual Analog Scale (VAS)

Description

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

Title

Level of Nausea Using VAS

Description

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

Title

Level of Nausea Using VAS

Description

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

Title

Level of Nausea Using VAS

Description

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

Secondary Outcome Measure Information:

Title

CBD Consumption

Description

Patient self report

Time Frame

Day 2 Post-Surgery

Title

CBD Consumption

Description

Patient self report

Time Frame

Day 7 Post-Surgery

Title

CBD Consumption

Description

Patient self report

Time Frame

Day 14 Post-Surgery

Title

Opioid Consumption

Description

Patient self report

Time Frame

Day 2 Post-Surgery

Title

Opioid Consumption

Description

Patient self report

Time Frame

Day 7 Post-Surgery

Title

Opioid Consumption

Description

Patient self report

Time Frame

Day 14 Post-Surgery

Title

Patient Satisfaction Score

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philipp Leucht, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU Langone Orthopedic Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10010

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Philipp.Leucht@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

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

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