Lidocaine Patches in Elderly Patients With Traumatic Rib Fractures

NCT ID: NCT05714631

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-08-01

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.

Conditions

Rib Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of care group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo Patch

Intervention Type: OTHER

Transdermal placebo patch

Intervention group

Group Type: EXPERIMENTAL

4% Lidocaine Patch

Intervention Type: DRUG

Transdermal patch

Interventions

Placebo Patch

Transdermal placebo patch

Intervention Type: OTHER

4% Lidocaine Patch

Transdermal patch

Intervention Type: DRUG

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Jacob Peschman, MD

Assistant professor of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Abdul Hafiz Al Tannir

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

PRO44982

Identifier Type: -

Identifier Source: org_study_id