Lidocaine Infusions for Rib Fractures

Study Overview
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Brief Summary
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Patients with traumatic rib fractures not receiving regional anesthesia through a epidural or nerve block catheter will be recruited for the study. Once enrolled, they will be randomized to receive either intravenous lidocaine or intravenous saline for control of pain related to their rib fractures. In addition, they will receive other pain medications, such as acetaminophen, gabapentin, and opioid pain medications. Our primary outcome is a decrease in their opioid medication requirements.

Official Title
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Efficacy of Intravenous Lidocaine Infusion for Traumatic Rib Fracture Pain Control

Conditions
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Trauma Chest, Rib Fracture Multiple, Pain, Acute

Intervention / Treatment
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* Drug: Lidocaine infusion
* Drug: Saline infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 or older with 2+ rib fractures or > 65 with 2+ rib fractures Enrollment within 16 hours of admission Inability to receive epidural placement or other catheter-based regional anesthesia (coagulopathy, anticoagulation, bacteremia or infection over epidural site, patient refusal, vertebral fracture, spinal cord injury, inability to cooperate with procedure, BMI > 40) Isolated rib fracture (no other major injury or anticipation for invasive procedure) Exclusion Criteria: Inability to participate in traditional pain measures Severe alcohol withdrawal Chronic pain requiring opiates prior to admission GCS < 13 or inability to report pain Medical instability Positive pressure ventilation, either via non-invasive mask or endotracheal tube Hemodynamic instability or shock Flail chest with clinical evidence of paradoxical rib motion Contraindication to lidocaine History of or current bradycardia (HR < 50) or heart block (Mobitz II or 3rd degree) New onset or uncontrolled seizures Allergy to amide-type local anesthetic Enrollment in other study that may affect the results of this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Will receive normal saline bolus and infusion and have sham lab draws every 8 hours. | Drug: Saline infusion<br>* Intravenous bolus of saline and then infusion<br>|
| Active Comparator: Lidocaine<br>Will receive lidocaine bolus and infusion and have lidocaine lab draws every 8 hours. | Drug: Lidocaine infusion<br>* Intravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid pain medicine usage | Total opioid pain medicine usage | Average per 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCA requirements | Percentage of patients requiring PCA | 5 days | 
| Pain score | Average pain scores | 5 days | 
| Length of stay | Average length of stay in ICU and hospital | 5 days | 
| Respiratory failure | Rates of pneumonia or other respiratory failure (pneumonia defined as (1) new pulmonary infiltrate on chest X-ray and (2) two of three of the following: (a) productive cough (b) WBC > 12,000 and (c) temperature > 38.0) | 5 days | 
| Death | Mortality rate between two groups | up to 30 days | 
| Mobility | Highest level of mobility on hospital day #2 | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine infusion