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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 30-days. from date of randomization until the date of patient discharge

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30-days. from date of randomization until the date of patient discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30-days. from date of randomization until the date of patient discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30-days. from date of randomization until the date of patient discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Oral Morphine equivalent

Patient reported pain score (scale from 0-10)

Secondary outcome measures

30-day opioid usage

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692

40%

Nausea

10%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Tumescent Solution With Dilute Epinephrine

Tumescent Solution With Dilute Lidocaine and Epinephrine

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

610 Previous Clinical Trials

1,162,620 Total Patients Enrolled

1 Trials studying Rib Fractures

153 Patients Enrolled for Rib Fractures

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor in need of new participants?

"According to clinicaltrials.gov, this trial is enrolling participants as it was most recently edited on 20th October 20203. It had originally been posted the 1st of October in that same year."

Answered by AI

Has Intervention group been granted regulatory approval by the FDA?

"Intervention group was rated a 3 on Power's safety scale as it has passed the last stage of clinical trials and is currently approved."

Answered by AI

To what extent has the populace participated in this clinical experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this research is currently recruiting participants, with 93 individuals needed at 1 site since it was first made available on October 1st 2023 and last updated in mid-October of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lidocaine Patches in Elderly Patients With Traumatic Rib Fractures

Jacob Peschman, MD 2023. "Lidocaine Patches in Elderly Patients With Traumatic Rib Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05714631.