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.