Clinical trial NCT02749968: Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
Official title: Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blunt Chest Wall Trauma
Rib Fracture
Sternal Fracture
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: United States Air Force
First posted: 2016-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid Requirement at 24 Hours Post-randomization
timeFrame: 24 hours following randomization.
measure: Opioid Requirement at 48 Hours Post-randomization.
timeFrame: 48 hours following randomization.
measure: Opioid Requirement at 72 Hours Post-randomization
timeFrame: 72 hours following randomization.
measure: Opioid Requirement at 96 Hours Post-randomization
timeFrame: 96 hours following randomization.
Secondary outcomes:
measure: Development of Pneumonia
timeFrame: 96 hours following randomization
measure: Self-reported Pain at 96 Hours Post-randomization
timeFrame: At 96 hours post-randomization
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: Department of Surgery, University of Cincinnati
name: Michael D Goodman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wallen TE, Singer KE, Makley AT, Athota KP, Janowak CF, Hanseman D, Salvator A, Droege ME, Strilka R, Droege CA, Goodman MD. Intercostal liposomal bupivacaine injection for rib fractures: A prospective randomized controlled trial. J Trauma Acute Care Surg. 2022 Feb 1;92(2):266-276. doi: 10.1097/TA.0000000000003462.