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Completed

NCT Number: NCT02749968

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal bupivacaine

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • United States Air Force

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 25, 2016
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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