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

Tracking Information

• First Submitted Date: April 18, 2016
• First Posted Date: April 25, 2016
• Results First Submitted Date: February 14, 2022
• Results First Posted Date: April 4, 2022
• Last Update Posted Date: April 4, 2022
• Actual Study Start Date: March 9, 2018
• Actual Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 14, 2022)

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

Original Primary Outcome Measures (submitted: April 20, 2016)

• Opioid requirement at 6 hours post-randomization [ Time Frame: 6 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 6 hours post-randomization
• Opioid requirement at 12 hours post-randomization [ Time Frame: 12 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 12 hours post-randomization
• Opioid requirement at 18 hours post-randomization [ Time Frame: 18 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 18 hours post-randomization
• Opioid requirement at 24 hours post-randomization [ Time Frame: 24 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 24 hours post-randomization
• Opioid requirement at 30 hours post-randomization [ Time Frame: 30 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 30 hours post-randomization
• Opioid requirement at 36 hours post-randomization [ Time Frame: 36 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 36 hours post-randomization
• Opioid requirement at 42 hours post-randomization [ Time Frame: 42 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 42 hours post-randomization
• Opioid requirement at 48 hours post-randomization. [ Time Frame: 48 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 48 hours post-randomization
• Opioid requirement at 54 hours post-randomization [ Time Frame: 54 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 54 hours post-randomization
• Opioid requirement at 60 hours post-randomization [ Time Frame: 60 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 60 hours post-randomization
• Opioid requirement at 66 hours post-randomization [ Time Frame: 66 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 66 hours post-randomization
• Opioid requirement at 72 hours post-randomization [ Time Frame: 72 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 72 hours post-randomization
• Opioid requirement at 78 hours post-randomization [ Time Frame: 78 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 78 hours post-randomization
• Opioid requirement at 84 hours post-randomization [ Time Frame: 84 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 84 hours post-randomization
• Opioid requirement at 90 hours post-randomization [ Time Frame: 90 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 90 hours post-randomization
• Opioid requirement at 96 hours post-randomization [ Time Frame: 96 hours following randomization. ]
  Opioid requirement (in morphine equivalents) at 96 hours post-randomization

Current Secondary Outcome Measures (submitted: March 8, 2022)

• 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.
• 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.

Original Secondary Outcome Measures (submitted: April 20, 2016)

• Development of pneumonia [ Time Frame: 96 hours following randomization ]
  Development of pneumonia defined as >100,000 cfu/mL bacteria on bronchoalveolar lavage or clinically with leukocytosis, pulmonary infiltrate and fever with 96 hours post-randomization.
• Self-reported pain every 6 hours post-randomization [ Time Frame: Every 6 hours from randomization until 96 hours post-randomization ]
  Self-reported pain will be measured using the verbal NRS, a 0-10 ordinal scale. Pain assessments will occur every 6 hours or per standard of care for the appropriate setting (e.g., intensive care unit, trauma ward) for the first 96 hours of hospital stay.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment

Condition

• Blunt Chest Wall Trauma
• Rib Fracture
• Sternal Fracture

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
• 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

Study Arms

• 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
  Intervention: Drug: Liposomal bupivacaine
• 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
  Intervention: Drug: 0.9% sodium chloride

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 20, 2016): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 1, 2021
• Actual Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02749968
• Other Study ID Numbers: Droege 2016
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Michael Goodman, University of Cincinnati
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Cincinnati
• Original Study Sponsor: Same as current
• Collaborators: United States Air Force

Investigators

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

• PRS Account: University of Cincinnati
• Verification Date: March 2022