Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

University of Cincinnati100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Blunt Chest Wall Trauma Rib Fracture Sternal Fracture

Interventions

Liposomal bupivacaineDRUG

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

0.9% sodium chlorideDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Opioid Requirement at 24 Hours Post-randomization

Opioid requirement (in morphine equivalents) at 24 hours post-randomization

Time frame: 24 hours following randomization.

Opioid Requirement at 48 Hours Post-randomization.

Opioid requirement (in morphine equivalents) at 48 hours post-randomization

Time frame: 48 hours following randomization.

Opioid Requirement at 72 Hours Post-randomization

Opioid requirement (in morphine equivalents) at 72 hours post-randomization

Time frame: 72 hours following randomization.

Opioid Requirement at 96 Hours Post-randomization

Opioid requirement (in morphine equivalents) at 96 hours post-randomization

Time frame: 96 hours following randomization.

Secondary Outcomes

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.

Time frame: 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.

Time frame: At 96 hours post-randomization

Data from ClinicalTrials.gov

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