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Lidocaine Patches for Rib Fractures

Phase 4
Recruiting
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial assesses if lidocaine patches help with rib fractures, reducing opioid use and improving quality of life. Outcome offers benefit to patient care, regardless of findings.

Who is the study for?
This trial is for elderly patients aged 65 or older who have traumatic rib fractures, can give consent, and are admitted to a trauma service with injuries not too severe (AIS score ≤2). It's not for those under 65, on chronic pain meds, prisoners, allergic to lidocaine/adhesive tape, or with more severe pain elsewhere.
What is being tested?
The study tests the effectiveness of a 4% Lidocaine Patch against a Placebo Patch in managing pain from rib fractures in the elderly. The goal is to see if it reduces opioid use and improves quality of life without wasting resources if ineffective.
What are the potential side effects?
Lidocaine patches may cause skin irritation or mild allergic reactions at the site of application. Compared to opioids and other pain medications, they generally have a lower risk profile for side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Intervention groupExperimental Treatment1 Intervention
Group II: Standard of care groupActive Control1 Intervention
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 III: Placebo groupPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
634 Previous Clinical Trials
1,181,612 Total Patients Enrolled
~43 spots leftby Dec 2025
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