Lidocaine IV vs. ESP Block for Rib Fractures

(Rib Fract ESP Trial)

Overseen By Ban Tsui, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Chronic opioids

Disqualifiers: Hemodynamic instability, Mechanical ventilation, Polytrauma, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to manage pain for individuals with acute rib fractures. One group receives a standard IV lidocaine infusion, while the other receives 2% lidocaine through an ESPB, a type of nerve block. Researchers aim to determine which method better controls pain, aids breathing exercises, and improves overall recovery. Individuals with two or more broken ribs from a recent accident may be suitable for this study. The findings could enhance pain management for rib injuries in hospitals. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in pain management.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using opioids chronically, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the erector spinae plane block (ESPB) with 2% lidocaine is generally safe. Large studies report that only about 2% of patients experienced minor issues, such as infection or a small hematoma. These issues are rare and usually not serious. ESPB effectively manages pain, particularly from rib fractures, without causing problems like unstable blood pressure.

Studies have found that intravenous (IV) lidocaine can reduce pain after surgery. However, its use specifically for rib fracture pain remains underexplored. Since this study is in an early testing phase, the treatment has been safely tested in humans before, but more information is needed to understand all possible side effects.

In summary, both treatments have been used safely in other situations, but more specific safety data exists for ESPB concerning rib fractures. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for rib fractures because they offer innovative pain management options. Unlike standard treatments that often rely on opioids, these approaches use lidocaine, a local anesthetic, delivered either through an ESP (erector spinae plane) block or intravenously (IV). The ESP block delivers lidocaine directly to the site of injury, potentially providing more targeted pain relief with fewer side effects. Meanwhile, the IV infusion offers a systemic approach that could provide consistent pain control throughout the body. These methods could reduce reliance on opioids, offering effective pain management with a lower risk of addiction.

What evidence suggests that this trial's treatments could be effective for rib fractures?

Research has shown that the erector spinae plane block (ESPB), which participants in this trial may receive, can effectively reduce pain in individuals with broken ribs. One study demonstrated a significant drop in pain levels after ESPB, with median scores decreasing from 7 (on a scale from 0 to 10) before the block to much lower scores afterward. Another study found that ESPB improved breathing and pain management without affecting blood pressure. Meanwhile, intravenous (IV) lidocaine, another treatment option in this trial, has been helpful for other types of post-surgery pain, although fewer studies specifically address its use for rib fractures. ESPB appears promising, as it has improved pain control and breathing in patients with rib fractures. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

Exclusion Criteria

Mechanical ventilation

Incarceration

Chronic opioid use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either continuous IV lidocaine infusion or ESPB for pain management in rib fractures

Up to 72 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores, incentive spirometry volumes, and pulmonary complications

Up to 10 days

Daily assessments during hospital stay

What Are the Treatments Tested in This Trial?

Interventions

• 2% Lidocaine via ESPB
• Lidocaine IV Infusion

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

10 mL of 2% lidocaine via ESPB

Group II: Control Arm Placebo Group 1 Intervention

1.0mg/kg/hr IV lidocaine infusion

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10410029/

Ultrasound guided erector spinae plane block versus ... The results of our study revealed that the ESPB effectively reduced pain associated with the unilateral traumatic flail chest and improved the arterial ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04707183

Comparison of Continuous Intravenous Lidocaine Infusion ... The investigators want to determine if ESPB can provide improved pain control in patients admitted for traumatic rib fractures compared to IV Lidocaine. The aim ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138325004292

Ultrasound-guided erector spinae plane block for traumatic ... Results. Pain scores were higher before ESPB (median [IQR], 7.0 [6.0–8.0]) than at any time point after the procedure (P ...

4. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.14579

The effect of erector spinae plane block on respiratory and ... Erector spinae plane blocks were associated with improved inspiratory capacity and analgesic outcomes following rib fracture, without haemodynamic instability.

5. wjes.biomedcentral.com wjes.biomedcentral.com/articles/10.1186/s13017-024-00567-2

Erector spinae plane block (ESPB) enhances hemodynamic ... In this retrospective analysis, we aim to evaluate the real-world efficacy of ESPB in patients with multiple rib fractures requiring SSRF.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10275321/

Erector Spinae Plane Block as an Analgesic Intervention in ... A 2% complication rate of infection and haematoma was demonstrated in the two largest cohort studies investigating safety,, while Elawamy et al ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04558281

Continuous Erector Spinae Plane Blocks for Rib Fractures The erector spinae plane block (ESPB) is a nerve block that covers multiple rib fractures with a single injection. This block entails injecting local anesthetic ...