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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02749968
Other study ID # Droege 2016
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 9, 2018
Est. completion date January 1, 2021

Study information

Verified date March 2022
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


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Study Design


Intervention

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
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

Locations

Country Name City State
United States University of Cincinnati Medical Center Cincinnati Ohio

Sponsors (2)

Lead Sponsor Collaborator
University of Cincinnati United States Air Force

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid Requirement at 24 Hours Post-randomization Opioid requirement (in morphine equivalents) at 24 hours post-randomization 24 hours following randomization.
Primary Opioid Requirement at 48 Hours Post-randomization. Opioid requirement (in morphine equivalents) at 48 hours post-randomization 48 hours following randomization.
Primary Opioid Requirement at 72 Hours Post-randomization Opioid requirement (in morphine equivalents) at 72 hours post-randomization 72 hours following randomization.
Primary Opioid Requirement at 96 Hours Post-randomization Opioid requirement (in morphine equivalents) at 96 hours post-randomization 96 hours following randomization.
Secondary 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. 96 hours following randomization
Secondary 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. At 96 hours post-randomization
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