NCT02749968

Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blunt Chest Wall Trauma
• Rib Fracture
• Sternal Fracture

Interventions

Type	Name	Description
DRUG	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
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

Timeline

• Start date: 2018-03-09
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2016-04-25
• Last updated: 2022-04-04
• Results posted: 2022-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study