Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

Rib Fracture Clinical Trial

Official title:

Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749968
• Other study ID #: Droege 2016
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blunt Chest Wall Trauma
• Fractures, Bone
• Rib Fracture
• Rib Fractures
• Sternal Fracture
• Wounds and Injuries

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