Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2021-01-01

Brief Summary

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

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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.

Conditions

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Blunt Chest Wall Trauma Rib Fracture Sternal Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

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 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

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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0.9% saline

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No