Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

Study Overview
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Brief Summary
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The current cornerstone of pain control for rib fractures is oral and intravenous opioids, especially in the form of patient-controlled analgesia (IV PCA), which are are associated with multiple adverse effects including sedation, respiratory depression, cough suppression, and increased risk of delirium. In the past few decades, intravenous lidocaine infusion (IVL) has emerged as a new tool in the arsenal of multimodal analgesia. Multiple randomized clinical trials have indicated that IVL is overall well tolerated and have shown other beneficial effects such as anti-inflammatory properties. To this date, there have been no published randomized clinical trials (RCT) evaluating the effectiveness of IVL in management of traumatic rib fracture pain. Therefore, the purpose of this study is to evaluate whether IV Lidocaine infusion can provide improved pain control as demonstrated by decreased OME consumption at 24 and 48 hours compared to placebo in adult patients with acute traumatic rib fractures.

Official Title
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A Prospective Comparison of Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

Conditions
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Rib Fractures

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures Exclusion Criteria: hemodynamically instability mechanical ventilation polytrauma (defined as bone or organ injury outside the thorax) pregnancy incarceration local anesthetic allergy or contraindications to lidocaine (Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular block) chronic opioid use.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Comparator<br>Participants will receive placebo infusion consisting of normal saline | Drug: Saline infusion<br>* Normal saline infusion at 10mL/hour<br>|
| Active Comparator: Active Comparator<br>Participants will receive a lidocaine infusion | Drug: Lidocaine infusion<br>* Lidocaine infusion at 1.0mg/kg/hr<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours | MME = morphine milligram equivalent | After 24 hours of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 48 Hrs |  | After 48 hours of treatment | 
| Pain Score | Pain scores at rest rated using the Numeric Rating Scale (NRS) of 0-10, where 0 is no pain and 10 is the worst imaginable | Baseline and 1, 10, 13, 16, and 17 hours post-lidocaine infusion | 
| Incentive Spirometry Volumes | An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale. | Pre-infusion baseline and 24 hours post-infusion | 
| PIC Score | PIC score is a composite score comprising pain level, ISV, and cough strength. PIC scores range from 1-10 with one being severe pain, inability to perform incentive spirometry, and absent cough and 10 being controlled pain, an incentive spirometry volume above goal volume (set by respiratory therapist), and strong cough. | Time 0, 24 hours, 48 hour, and 72 hours. | 
| Length of Hospital Stay | Number of hours stayed at the hospital from the day of operation till the day of discharge. | 29 hours | 
| Inflammatory Biomarkers | Proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10) | Time 0, 24 hours, and 48 hour | 
| Number of Pulmonary Complication Events | Pulmonary complications include ARDS, pneumonia, aspiration, empyema, etc. | 29 hours |