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Local Anesthetic

Pain Relief Techniques for Rib Fractures

Phase 4
Recruiting
Led By Eric Schwenk, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 55 years old
Sustained 3 or more unilateral rib fractures and are admitted to the hospital
Must not have
Allergy to amide local anesthetics or any study medications
Bilateral rib fractures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline prior to intervention
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare three different pain relief methods for rib fractures in patients over 55 years old. The methods are ESP block with catheter using ropivacaine, lidocaine bolus and

Who is the study for?
This trial is for adults over 55 with at least three rib fractures on one side, admitted to the hospital. They can't join if they're allergic to certain anesthetics, pregnant, have bilateral rib fractures, blood clotting issues, heart conduction problems, weigh under 40 kg or have other severe injuries or infections that could interfere.
What is being tested?
The study compares three pain management methods for rib fractures: ESP block with ropivacaine infusion; lidocaine bolus and infusion; versus standard care including opioids. It aims to assess opioid use, pain levels, lung function improvements and potential reduction in chronic pain or long-term opioid need.
What are the potential side effects?
Possible side effects include reactions to local anesthetics like swelling or redness at the injection site, nerve damage risks from blocks (rare), low blood pressure from infusions and typical opioid-related issues such as nausea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 55 years old or older.
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I have three or more broken ribs on one side and am hospitalized.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to certain local anesthetics or study drugs.
Select...
I have fractures in ribs on both sides of my body.
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I have a spine fracture where the ESP block is planned.
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I do not have an infection or severe infection in my blood near where a medical device was or will be placed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brief Pain Inventory - current pain subscale (0-10)
Opioid Use in oral morphine equivalents (OME)
Secondary study objectives
3D-CAM/CAM-ICU
Brief Pain Inventory
Daily opioid Use
+10 more

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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: ESP block with catheter using ropivacaine (bolus followed by continuous infusion)Experimental Treatment1 Intervention
Group II: Standard care with multimodal analgesia and opioidsActive Control1 Intervention
Group III: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/hActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
463 Previous Clinical Trials
175,700 Total Patients Enrolled
Eric Schwenk, MDPrincipal InvestigatorThomas Jefferson University
1 Previous Clinical Trials
159 Total Patients Enrolled
~16 spots leftby Jul 2025
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