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NCT05714631 · ClinicalTrials.gov registry record · Phase 4
Lidocaine Patches in Elderly Patients With Traumatic Rib Fractures
A Phase 4 study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT05714631 is a Phase 4 study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 5 participants.
The verdict
NCT05714631, a Phase 4 study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo Patch
- DRUG 4% Lidocaine Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2024-08-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05714631
The ClinicalTrials.gov registry entry for NCT05714631 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Patch is the first listed.
NCT05714631 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05714631 about?
NCT05714631 is a clinical study titled "Lidocaine Patches in Elderly Patients With Traumatic Rib Fractures". 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 pati...
What is the current status of trial NCT05714631?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2023-10-01. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT05714631?
The interventions under investigation include: Placebo Patch (OTHER), 4% Lidocaine Patch (DRUG).
Who is sponsoring clinical trial NCT05714631?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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