Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

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

Study Overview

• Status: Completed
• Conditions: Rib Fracture; Sternal Fracture; Blunt Chest Wall Trauma
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: 0.9% sodium chloride

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45216
      • University of Cincinnati Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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: 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
Placebo Comparator: 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	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; Other Names: 0.9% saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Requirement at 24 Hours Post-randomization	Opioid requirement (in morphine equivalents) at 24 hours post-randomization	24 hours following randomization.
Opioid Requirement at 48 Hours Post-randomization.	Opioid requirement (in morphine equivalents) at 48 hours post-randomization	48 hours following randomization.
Opioid Requirement at 72 Hours Post-randomization	Opioid requirement (in morphine equivalents) at 72 hours post-randomization	72 hours following randomization.
Opioid Requirement at 96 Hours Post-randomization	Opioid requirement (in morphine equivalents) at 96 hours post-randomization	96 hours following randomization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: United States Air Force
• Investigators: Principal Investigator: Michael D Goodman, MD, Department of Surgery, University of Cincinnati

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: April 18, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Thoracic Injuries; Wounds and Injuries; Fractures, Bone; Rib Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Droege 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No