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

160 Participants Needed

Trial Summary

What is the purpose of this trial?

Recently in 2016, a new interfascial plane nerve block was developed for thoracic analgesia known as the erector spinae plane block (ESPB). Since its development for thoracic neuropathic pain, the ESPB has been shown to be effective in pain control in multiple procedures including thoracotomies. However, there have been a few published case reports of using ESPB for analgesia in rib fracture management and only one retrospective study which demonstrated improved NRS pain scores and increased incentive spirometry volumes (ICV) post-ESPB compared to pre-ESPB values. The goal of this study is to 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. At the investigator's institution, the current standard of care is intravenous (IV) and enteral multimodal analgesia that consists primarily of opioids and a continuous IV lidocaine infusion. Although IV lidocaine has shown some benefit in improving post-surgical pain scores, evidence for its use in MRF is lacking. The purpose of this study is to perform a randomized clinical trial comparing outcomes in pain control and incentive spirometry volumes between continuous ESPB catheters and IV lidocaine infusions in adult patients with acute traumatic rib fractures. 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 is to evaluate the clinical effectiveness of ESPB on OME consumption, pain scores, incentive spirometry volumes, cough strength, respiratory complications, inflammatory biomarkers and hospital LOS. Findings from this study can help improve analgesia, quality of care, and patient satisfaction at Stanford Healthcare and for other acute pain and trauma surgery providers. The aim of this study involves pain management for patients with acute traumatic rib fractures and therefore must involve human subjects.

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.

What data supports the effectiveness of the drug Lidocaine IV for rib fractures?

Research shows that intravenous lidocaine is effective in managing pain for traumatic rib fractures, as well as in other conditions like postoperative thoracic and abdominal surgery. It has been found to reduce opioid use and improve pain control, which is crucial for preventing complications in rib fracture patients. ^{1 2 3 4 5}

Is intravenous lidocaine safe for humans?

Intravenous lidocaine has been shown to be safe in humans for managing pain after surgeries and in various conditions like cancer pain and chronic neuropathic pain. ^{1 2 3 4 6}

How does the treatment of Lidocaine IV vs. ESP Block for rib fractures differ from other treatments?

This treatment is unique because it compares two methods of delivering lidocaine, a pain-relieving drug, for rib fractures: intravenously (directly into the bloodstream) and via an erector spinae plane block (a regional anesthesia technique targeting nerves near the spine). This approach aims to provide effective pain relief while potentially reducing the need for narcotics, which can have significant side effects. ^{1 2 3 4 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of intravenous lidocaine versus epidural anesthesia for traumatic rib fracture pain: a retrospective cohort study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine for the management of traumatic rib fractures: A double-blind randomized controlled trial (INITIATE program of research). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Intravenous Lidocaine for Rib Fractures: Effect on Pain Control and Outcome. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Do Lidocaine Patches Reduce Opioid Use in Acute Rib Fractures? [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine as a non-opioid adjunct analgesic for traumatic rib fractures. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Interpleural block for patients with multiple rib fractures: comparison with epidural block. [2019]