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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.

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.

Awards & highlights

Rib Fract ESP Trial 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.Check my eligibility

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.See study design

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.

Rib Fract ESP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have two or more broken ribs from a recent injury.

Select...

I have two or more broken ribs from a recent injury.

Rib Fract ESP Trial Timeline

Screening ~ 3 weeks3 visits

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.

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

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

Primary outcome measures

OME consumption at 24 hours of treatment.

Secondary outcome measures

Incentive spirometry volumes (volume of 0 - 5000 mL)

Inflammatory biomarkers

Length of hospital stay

+4 more

Rib Fract ESP 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,394 Previous Clinical Trials

17,341,450 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

Frequently Asked Questions

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

Are there analogous studies that have probed the effects of 2% Lidocaine delivered through ESPB?

"Presently, 118 medical trials concerning 2% Lidocaine through ESPB are in progress with 31 of them being in the advanced Phase 3 stage. Calgary, Alberta is home to most of these studies; however there are 1,094 additional clinical trial sites across the globe providing this medication."

Answered by AI

What is the current participation count for this experiment?

"This medical experiment has ceased its patient recruitment, as the last edits were made on January 18th 2022. If you are currently seeking alternative studies then there are 348 trials for rib fractures and 118 opportunities in the 2% Lidocaine via ESPB space which remain open to applicants."

Answered by AI

Is there a possibility for new participants to join this trial?

"Based on clinicaltrials.gov, this medical study is not currently enrolling patients at the present time. This trial was first published on October 1st 2022 and last updated eighteen days later. Though no longer recruiting for its own purposes, there are 466 other studies actively searching for participants right now."

Answered by AI

Is the participant pool for this experiment limited to those above octogenarian age?

"According to the requirements posed by this experiment, potential participants must have an age between 18 and 80. Subsequently, there are 76 trials for minors and 388 for seniors."

Answered by AI

What medical conditions is 2% Lidocaine via ESPB employed to treat?

"2% Lidocaine through an epidural steroid block is the customary treatment for cervical syndrome, but it may also be prescribed to tackle less serious burns, post-transplantation care, and osteoporosis."

Answered by AI

Do I fulfill the criteria for taking part in this experimental endeavor?

"To be considered for inclusion, applicants must possess rib fractures and should fall between the ages of 18-80. In total, 160 individuals have been invited to partake in this trial."

Answered by AI

Is the use of 2% Lidocaine via ESPB a formally accepted practice by the FDA?

"There are some data supporting the safety of 2% Lidocaine via ESPB, so it received a rating of 2. Although this clinical trial is in Phase 2 and has not yet produced any evidence to support efficacy."

Answered by AI

Recent research and studies

AnesthesiologyJournal

Local Anesthetics and the Inflammatory Response

Hollmann, Markus W., Marcel E. Durieux, and Dennis M. Fisher. 2000. “Local Anesthetics and the Inflammatory Response”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000542-200009000-00038.

clinicaltrials.govStudy

Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia

Chi-Ho Ban Tsui 2024. "Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04707183.

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