Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

Phase 2

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
0.9% sodium chloride	0.9% sodium chloride	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
Liposomal bupivacaine	Liposomal bupivacaine	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

Primary Outcome Measures

Name	Time	Method
Opioid Requirement at 48 Hours Post-randomization.	48 hours following randomization.	Opioid requirement (in morphine equivalents) at 48 hours post-randomization
Opioid Requirement at 72 Hours Post-randomization	72 hours following randomization.	Opioid requirement (in morphine equivalents) at 72 hours post-randomization
Opioid Requirement at 96 Hours Post-randomization	96 hours following randomization.	Opioid requirement (in morphine equivalents) at 96 hours post-randomization
Opioid Requirement at 24 Hours Post-randomization	24 hours following randomization.	Opioid requirement (in morphine equivalents) at 24 hours post-randomization

Secondary Outcome Measures

Name	Time	Method
Development of Pneumonia	96 hours following randomization	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.
Self-reported Pain at 96 Hours Post-randomization	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.