Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05714631 |
| Other study ID # |
PRO44982 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
November 1, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Medical College of Wisconsin |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
