Lidocaine Patches in Elderly Patients With Traumatic Rib Fractures

NCT05714631 | Terminated Phase 4 FDA Drug

• 1 other identifier: PRO44982
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (2)

• Oral Morphine equivalent

  Up to 30-days. From date of randomization until the date of patient discharge

• Patient reported pain score (scale from 0-10)

  Up to 30-days. From date of randomization until the date of patient discharge

Secondary Outcomes (1)

• 30-day opioid usage

  30-day post discharge using the Wisconsin Prescription Drug Monitoring Program

Study Arms (3)

Standard of care group

NO 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

Placebo group

PLACEBO COMPARATOR

Other: Placebo Patch

Intervention group

EXPERIMENTAL

Drug: 4% Lidocaine Patch

Interventions

Placebo Patch OTHER

Transdermal placebo patch

Placebo group

4% Lidocaine Patch DRUG

Transdermal patch

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• age\>/= 65 years
• Patients with injuries meeting an AIS score \</=2
• Patients admitted to trauma service
• Patients able to consent

You may not qualify if:

• Age \<65 years
• Unable to consent
• Chronic pain medication usage; defined as \>/= 3 weeks of \>/= 30 mg oral morphine equivalent
• History of allergic reaction to lidocaine or adhesive tape
• Prisoners
• Patient will be excluded if pain is worse in non-ribs location
• Patient will be excluded if he has injuries not meeting our criteria

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Abdul Hafiz Al Tannir

Milwaukee, Wisconsin, 53213, United States

Location

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of surgery

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: October 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)