Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

Study Overview
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Brief Summary
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This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall trauma.

Detailed Description
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The purpose of this study is to evaluate the efficacy of liposomal bupivacaine to provide analgesia via paravertebral intercostal nerve block following significant blunt chest trauma, minimizing adverse outcomes, length of stay and overall narcotic use. The primary outcome of the study is to compare requirements between the bupivacaine group and a standard-of-care group.

Official Title
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Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

Conditions
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Blunt Chest Wall Trauma, Rib Fracture, Sternal Fracture

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: 0.9% sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anticipated length of stay of at least 72 hours Blunt chest wall trauma with two or more rib or sternal fractures Demonstrated ability to achieve > 50% predicted inspiratory capacity based on ideal body weight using IS within the first 24 hours of admission Exclusion Criteria: Known allergy to bupivacaine Respiratory failure requiring intubation within 24 hours prior to enrollment Known or suspected atrioventricular nodal blockade process requiring cardiology evaluation or pacemaker placement Hemodynamic instability (defined as new intravenous vasopressor or inotrope requirement or mean arterial pressure < 55 mmHg) Signs of active myocardial ischemia or non-ST elevation MI > 20 rib fractures Weight < 50 kg or > 150 kg Pregnancy Incarceration

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposomal bupivacaine<br>1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position | Drug: Liposomal bupivacaine<br>* 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position<br>|
| Placebo Comparator: 0.9% sodium chloride<br>1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position | Drug: 0.9% sodium chloride<br>* 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position<br>* Other names: 0.9% saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Requirement at 24 Hours Post-randomization | Opioid requirement (in morphine equivalents) at 24 hours post-randomization | 24 hours following randomization. | 
| Opioid Requirement at 48 Hours Post-randomization. | Opioid requirement (in morphine equivalents) at 48 hours post-randomization | 48 hours following randomization. | 
| Opioid Requirement at 72 Hours Post-randomization | Opioid requirement (in morphine equivalents) at 72 hours post-randomization | 72 hours following randomization. | 
| Opioid Requirement at 96 Hours Post-randomization | Opioid requirement (in morphine equivalents) at 96 hours post-randomization | 96 hours following randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Pneumonia | Development of pneumonia defined as >100,000 colony forming units/milliliter bacteria on bronchoalveolar lavage or clinically with leukocytosis, pulmonary infiltrate and fever with 96 hours post-randomization. | 96 hours following randomization | 
| Self-reported Pain at 96 Hours Post-randomization | Self-reported pain will be measured using the verbal NRS, a 0-10 ordinal scale. Pain assessments will be reported at 96 hours after enrollment, as this is the reported duration of effect for liposomal bupivacaine. Higher scores (10) indicate more pain, lower scores (0) indicate lower pain. | At 96 hours post-randomization |