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Local Anesthetic

Lidocaine IV vs. ESP Block for Rib Fractures (Rib Fract ESP Trial)

Phase 2
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures.
- All adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures.
Must not have
Hemodynamically instability
Polytrauma (defined as bone or organ injury outside the thorax)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration.

Summary

This trial will compare the effectiveness of ESPB as an alternative method to the current standard of care at Stanford Health Care (SHC) for pain management in traumatic rib fractures.

Who is the study for?
This trial is for adults at Stanford Health Care with two or more acute traumatic rib fractures. It's not for those on mechanical ventilation, with lidocaine allergies or heart conduction problems, chronic opioid users, pregnant women, prisoners, unstable vital signs, or injuries beyond the chest area.
What is being tested?
The study compares pain management methods for rib fractures: continuous intravenous (IV) Lidocaine infusion versus a new nerve block called ESPB. The goal is to see which method better controls pain and improves breathing efforts after injury.
What are the potential side effects?
Possible side effects include allergic reactions to lidocaine such as rash or itching; nervous system issues like dizziness or seizures; and heart-related side effects including changes in blood pressure or irregular heartbeat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have two or more broken ribs from a recent injury.
Select...
I have two or more broken ribs from a recent injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My blood pressure and heart rate are stable.
Select...
I have injuries to bones or organs outside my chest area.
Select...
I am allergic to local anesthetics or have specific heart conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
OME consumption at 24 hours of treatment.
Secondary study objectives
Incentive spirometry volumes (volume of 0 - 5000 mL)
Inflammatory biomarkers
Length of hospital stay
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
10 mL of 2% lidocaine via ESPB
Group II: Control ArmPlacebo Group1 Intervention
1.0mg/kg/hr IV lidocaine infusion

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,472 Previous Clinical Trials
17,501,658 Total Patients Enrolled
5 Trials studying Rib Fractures
190 Patients Enrolled for Rib Fractures

Media Library

2% Lidocaine via ESPB (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04707183 — Phase 2
Rib Fractures Research Study Groups: Control Arm, Treatment Arm
Rib Fractures Clinical Trial 2023: 2% Lidocaine via ESPB Highlights & Side Effects. Trial Name: NCT04707183 — Phase 2
2% Lidocaine via ESPB (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04707183 — Phase 2
~0 spots leftby Dec 2024