ClinicalTrials.gov
ClinicalTrials.gov Menu

Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02749968
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
United States Air Force
Information provided by (Responsible Party):
Michael Goodman, University of Cincinnati

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Opioid requirement at 6 hours post-randomization [ Time Frame: 6 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 6 hours post-randomization

  2. Opioid requirement at 12 hours post-randomization [ Time Frame: 12 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 12 hours post-randomization

  3. Opioid requirement at 18 hours post-randomization [ Time Frame: 18 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 18 hours post-randomization

  4. Opioid requirement at 24 hours post-randomization [ Time Frame: 24 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 24 hours post-randomization

  5. Opioid requirement at 30 hours post-randomization [ Time Frame: 30 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 30 hours post-randomization

  6. Opioid requirement at 36 hours post-randomization [ Time Frame: 36 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 36 hours post-randomization

  7. Opioid requirement at 42 hours post-randomization [ Time Frame: 42 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 42 hours post-randomization

  8. Opioid requirement at 48 hours post-randomization. [ Time Frame: 48 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 48 hours post-randomization

  9. Opioid requirement at 54 hours post-randomization [ Time Frame: 54 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 54 hours post-randomization

  10. Opioid requirement at 60 hours post-randomization [ Time Frame: 60 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 60 hours post-randomization

  11. Opioid requirement at 66 hours post-randomization [ Time Frame: 66 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 66 hours post-randomization

  12. Opioid requirement at 72 hours post-randomization [ Time Frame: 72 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 72 hours post-randomization

  13. Opioid requirement at 78 hours post-randomization [ Time Frame: 78 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 78 hours post-randomization

  14. Opioid requirement at 84 hours post-randomization [ Time Frame: 84 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 84 hours post-randomization

  15. Opioid requirement at 90 hours post-randomization [ Time Frame: 90 hours following randomization. ]
    Opioid requirement (in morphine equivalents) at 90 hours post-randomization

  16. 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 cfu/mL bacteria on bronchoalveolar lavage or clinically with leukocytosis, pulmonary infiltrate and fever with 96 hours post-randomization.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749968


Contacts
Contact: Christopher Droege, PharmD 513-584-8053 droegeca@ucmail.uc.edu
Contact: Michael D Goodman, MD 513-558-5661 goodmamd@ucmail.uc.edu

Locations
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45216
Contact: Molly Droege, PharmD    513-584-2126      
Sponsors and Collaborators
University of Cincinnati
United States Air Force
Investigators
Principal Investigator: Michael D Goodman, MD Department of Surgery, University of Cincinnati

Responsible Party: Michael Goodman, instructor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02749968     History of Changes
Other Study ID Numbers: Droege 2016
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
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