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Lidocaine Patches in Elderly Patients With Traumatic Rib Fractures

Primary Purpose

Rib Fractures

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo Patch
4% Lidocaine Patch
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: age>/= 65 years Patients with injuries meeting an AIS score </=2 Patients admitted to trauma service Patients able to consent Exclusion Criteria: Age <65 years Unable to consent Chronic pain medication usage; defined as >/= 3 weeks of >/= 30 mg oral morphine equivalent History of allergic reaction to lidocaine or adhesive tape Prisoners Patient will be excluded if pain is worse in non-ribs location Patient will be excluded if he has injuries not meeting our criteria

Sites / Locations

  • Abdul Hafiz Al TannirRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Experimental

Arm Label

Standard of care group

Placebo group

Intervention group

Arm Description

Patients in the standard of care will not be receiving any lidocaine or placebo patches. The aim of this group is to control for the placebo effect

Outcomes

Primary Outcome Measures

Oral Morphine equivalent
Patient reported pain score (scale from 0-10)

Secondary Outcome Measures

30-day opioid usage

Full Information

First Posted
January 26, 2023
Last Updated
October 20, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT05714631
Brief Title
Lidocaine Patches in Elderly Patients With Traumatic Rib Fractures
Official Title
A Single-blind Randomized Placebo Controlled Trial of Lidocaine Patches for Opioid Reduction in Geriatric Rib Fracture Patients Admitted to the Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
Many patients are prescribed lidocaine patches for rib fractures despite mixed evidence to their efficacy. The outcome of this trial offers significant benefit to patient care if it finds benefit of their use or if it does not. Reducing opioid use and increasing functional outcomes in geriatric patient suffering rib fractures can improve quality of life and ability to return to prior levels of function. Limiting the need for opioid prescriptions dispensed in the community, particularly to vulnerable geriatric individuals, is also a key aspect in curbing the opioid epidemic. However, even if no difference is found, it would support stopping the use of lidocaine patches in this population as a waste of money and resources. The novel approach of adding the 3rd arm to assess for placebo effect will also carry clinical value, as a placebo effect that reduces opioid use may in fact be enough to support continued use of the products given their overall low side effect risk profile compared to opioids and other pain control medications.
Detailed Description
Many patients are prescribed lidocaine patches for rib fractures despite mixed evidence to their efficacy. The outcome of this trial offers significant benefit to patient care if it finds benefit of their use or if it does not. Reducing opioid use and increasing functional outcomes in geriatric patient suffering rib fractures can improve quality of life and ability to return to prior levels of function. Limiting the need for opioid prescriptions dispensed in the community, particularly to vulnerable geriatric individuals, is also a key aspect in curbing the opioid epidemic. However, even if no difference is found, it would support stopping the use of lidocaine patches in this population as a waste of money and resources. The novel approach of adding the 3rd arm to assess for placebo effect will also carry clinical value, as a placebo effect that reduces opioid use may in fact be enough to support continued use of the products given their overall low side effect risk profile compared to opioids and other pain control medications AIM 1: Determine if a 3-armed placebo controlled randomized trial evaluating the efficacy of 4% lidocaine patches is feasible on a large scale with up to 500 enrolled patients across multiple institutions. Objective 1: Evaluate the study design, randomization system, drug delivery and placebo creation processes to determine barriers to a larger multicenter study design. AIM 2: Determine if the use of 4% lidocaine patches decreases the utilization of opioids in geriatric (Age ≥65) patient with rib fractures and minimal other injuries by 50% or more during the first 72 hours of hospitalization. Objective 2: Determine an appropriate target opioid reduction rate and appropriate enrollment numbers for a future a larger scale trial. We suspect a 50% opioid reduction may be larger than would be expected for a single aspect of multimodal pain control treatment. While the study will be powered to identify this difference, it is more likely that a 20-40% reduction could be achieved and therefore help determine appropriate power calculations for a future trial. AIM 3: Determine if there is a potential placebo effect of topical patch therapy. Objective 3: Utilizing a 3rd arm increases the number of patients needed to enroll but will help clarify if there is a significant placebo effect from the application of a non-medicated patch over rib fractures. There may be clinical benefit from this placebo effect itself which would need to be accounted for clinical recommendations generated from this and future studies. AIM 4: Include post discharge opioid usage in analysis to determine the prolonged pain needs of patients suffering rib fractures. Objective 4: Assess the feasibility of incorporating opioid prescription data using the Wisconsin Prescription Drug Monitoring Program (WI PDMP)as part of a clinical trial as a measure of post discharge opioid use. Approved study staff will be screening the trauma surgery patients list. Elderly patients (>/=65) with traumatic rib fractures will be approached within 24 hours after admission. Approved study staff will explain the project and informed consent in its entirety. Patients will then be randomized to one of 3 arms: 4% Lidocaine Patches, Placebo, Standard of Care (no lidocaine patch). Randomization will take place using RedCap database. The patients will receive the study drug or placebo as recommended by the manufacturer as 12 hours on, 12 hours off regimen. The patch location will be selected by the patient and nurse based on site of maximal pain. The patient will receive 1 drug or placebo patch for 1-3 rib fractures, 2 patches if 4-6 rib fractures, and 3 patches (maximum dose) if & or more fractures. The 4% Lidocaine patches will be obtained from the Froedtert Investigational Drug Office and dispensed with enough supply to last for 3 patch cycles in 5 days. The patches will then have kinesio tape (designed for topical application) applied over the patch to blind the patients to whether it is a study drug or placebo. For placebo, a double thickness similarly shaped piece of kinesio tape will be used. Based on drug efficacy, all patches can be prepared at the time of study enrollment and remain viable for use during the duration of the study. Patients in the standard of care arm will not receive a patch. All other pain medications will be prescribed at the discretion of treating providers based on standard of care (see section 52.1 Pain Management Protocol Lidocaine RCT). Approved study staff will be accessing patient's electronic medical record 5 days after enrollment; approved study staff will gather information regarding pain score (scored out of 10) and oral morphine equivalent (OME). Dr. Jacob Peschman is the director of outpatient services; he will be accessing patient's 30-day post discharge opioid use utilizing the Wisconsin Prescription Drug Monitoring Program (PDMP). Patients will be approached by approved study staff 30-days post discharge. Patients will be asked several questions regarding pain score and control.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care group
Arm Type
No Intervention
Arm Description
Patients in the standard of care will not be receiving any lidocaine or placebo patches. The aim of this group is to control for the placebo effect
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Title
Intervention group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Placebo Patch
Intervention Description
Transdermal placebo patch
Intervention Type
Drug
Intervention Name(s)
4% Lidocaine Patch
Intervention Description
Transdermal patch
Primary Outcome Measure Information:
Title
Oral Morphine equivalent
Time Frame
Up to 30-days. From date of randomization until the date of patient discharge
Title
Patient reported pain score (scale from 0-10)
Time Frame
Up to 30-days. From date of randomization until the date of patient discharge
Secondary Outcome Measure Information:
Title
30-day opioid usage
Time Frame
30-day post discharge using the Wisconsin Prescription Drug Monitoring Program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age>/= 65 years Patients with injuries meeting an AIS score </=2 Patients admitted to trauma service Patients able to consent Exclusion Criteria: Age <65 years Unable to consent Chronic pain medication usage; defined as >/= 3 weeks of >/= 30 mg oral morphine equivalent History of allergic reaction to lidocaine or adhesive tape Prisoners Patient will be excluded if pain is worse in non-ribs location Patient will be excluded if he has injuries not meeting our criteria
Facility Information:
Facility Name
Abdul Hafiz Al Tannir
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdul Hafiz Al Tannir
Phone
414-324-3583
Email
ahatannir@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Lidocaine Patches in Elderly Patients With Traumatic Rib Fractures

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