Phase 2
N=100
Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
Blunt Chest Wall Trauma · Rib Fracture · Sternal Fracture
Bottom Line
View on ClinicalTrials.gov: NCT02749968 ↗Enrolled (actual)
100
Serious AEs
6.0%
Results posted
Apr 2022
Primary outcome: Primary: Opioid Requirement at 24 Hours Post-randomization — 38; 202 morphine milligram equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Liposomal bupivacaine (Drug); 0.9% sodium chloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Requirement at 24 Hours Post-randomization |
38; 202 | — |
| PRIMARY Opioid Requirement at 48 Hours Post-randomization. |
298; 82 | — |
| PRIMARY Opioid Requirement at 72 Hours Post-randomization |
413; 116 | — |
| PRIMARY Opioid Requirement at 96 Hours Post-randomization |
637; 39 | — |
| SECONDARY Development of Pneumonia |
3; 1 | — |
| SECONDARY Self-reported Pain at 96 Hours Post-randomization |
6.32; 6.44 | — |
Summary
This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall trauma.
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 20 rib fractures
- Weight 150 kg
- Pregnancy
- Incarceration
Data sourced from ClinicalTrials.gov (NCT02749968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.