Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

• ClinicalTrials.gov Identifier: NCT02749968
• Recruitment Status: Completed
• First Posted: April 25, 2016
• Results First Posted: April 4, 2022
• Last Update Posted: April 4, 2022
• Sponsor: University of Cincinnati
• Collaborator: United States Air Force
• Information provided by (Responsible Party): Michael Goodman, University of Cincinnati

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Blunt Chest Wall Trauma; Rib Fracture; Sternal Fracture	Drug: Liposomal bupivacaine; Drug: 0.9% sodium chloride	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
• Actual Study Start Date: March 9, 2018
• Actual Primary Completion Date: January 1, 2021
• Actual Study Completion Date: January 1, 2021

Arms and Interventions

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 Name: 0.9% saline

Outcome Measures

Primary Outcome Measures :

1. Opioid Requirement at 24 Hours Post-randomization [ Time Frame: 24 hours following randomization. ]
   Opioid requirement (in morphine equivalents) at 24 hours post-randomization
2. Opioid Requirement at 48 Hours Post-randomization. [ Time Frame: 48 hours following randomization. ]
   Opioid requirement (in morphine equivalents) at 48 hours post-randomization
3. Opioid Requirement at 72 Hours Post-randomization [ Time Frame: 72 hours following randomization. ]
   Opioid requirement (in morphine equivalents) at 72 hours post-randomization
4. Opioid Requirement at 96 Hours Post-randomization [ Time Frame: 96 hours following randomization. ]
   Opioid requirement (in morphine equivalents) at 96 hours post-randomization

Secondary Outcome Measures :

1. Development of Pneumonia [ Time Frame: 96 hours following randomization ]
   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.
2. Self-reported Pain at 96 Hours Post-randomization [ Time Frame: 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.

Eligibility Criteria

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

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 < 55 mmHg)
• Signs of active myocardial ischemia or non-ST elevation MI
• > 20 rib fractures
• Weight < 50 kg or > 150 kg
• Pregnancy
• Incarceration

Contacts and Locations

Locations

United States, Ohio

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45216

Sponsors and Collaborators

University of Cincinnati

United States Air Force

Investigators

• Principal Investigator: Michael D Goodman, MD; Department of Surgery, University of Cincinnati

  Study Documents (Full-Text)

Documents provided by Michael Goodman, University of Cincinnati:

Study Protocol and Statistical Analysis Plan  [PDF] October 24, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Michael Goodman, instructor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT02749968
• Other Study ID Numbers: Droege 2016
• First Posted: April 25, 2016
• Results First Posted: April 4, 2022
• Last Update Posted: April 4, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fractures, Bone; Wounds and Injuries; Rib Fractures; Thoracic Injuries; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents