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Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

Primary Purpose

Blunt Chest Wall Trauma, Rib Fracture, Sternal Fracture

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
0.9% sodium chloride
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blunt Chest Wall Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cincinnati Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Liposomal bupivacaine

0.9% sodium chloride

Arm Description

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

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

Outcomes

Primary Outcome Measures

Opioid Requirement at 24 Hours Post-randomization
Opioid requirement (in morphine equivalents) at 24 hours post-randomization
Opioid Requirement at 48 Hours Post-randomization.
Opioid requirement (in morphine equivalents) at 48 hours post-randomization
Opioid Requirement at 72 Hours Post-randomization
Opioid requirement (in morphine equivalents) at 72 hours post-randomization
Opioid Requirement at 96 Hours Post-randomization
Opioid requirement (in morphine equivalents) at 96 hours post-randomization

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 18, 2016
Last Updated
March 30, 2022
Sponsor
University of Cincinnati
Collaborators
United States Air Force
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1. Study Identification

Unique Protocol Identification Number
NCT02749968
Brief Title
Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
Official Title
Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
United States Air Force

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blunt Chest Wall Trauma, Rib Fracture, Sternal Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liposomal bupivacaine
Arm Type
Active Comparator
Arm Description
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
Arm Title
0.9% sodium chloride
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride
Other Intervention Name(s)
0.9% saline
Intervention Description
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
Primary Outcome Measure Information:
Title
Opioid Requirement at 24 Hours Post-randomization
Description
Opioid requirement (in morphine equivalents) at 24 hours post-randomization
Time Frame
24 hours following randomization.
Title
Opioid Requirement at 48 Hours Post-randomization.
Description
Opioid requirement (in morphine equivalents) at 48 hours post-randomization
Time Frame
48 hours following randomization.
Title
Opioid Requirement at 72 Hours Post-randomization
Description
Opioid requirement (in morphine equivalents) at 72 hours post-randomization
Time Frame
72 hours following randomization.
Title
Opioid Requirement at 96 Hours Post-randomization
Description
Opioid requirement (in morphine equivalents) at 96 hours post-randomization
Time Frame
96 hours following randomization.
Secondary Outcome Measure Information:
Title
Development of Pneumonia
Description
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.
Time Frame
96 hours following randomization
Title
Self-reported Pain at 96 Hours Post-randomization
Description
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.
Time Frame
At 96 hours post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Goodman, MD
Organizational Affiliation
Department of Surgery, University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45216
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34789700
Citation
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.
Results Reference
derived

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Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

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