NCT02749968

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 9, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 4, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

2.8 years

First QC Date

April 18, 2016

Results QC Date

February 14, 2022

Last Update Submit

March 30, 2022

Conditions

Blunt Chest Wall TraumaRib FractureSternal Fracture

Outcome Measures

Primary Outcomes (4)

  • Opioid Requirement at 24 Hours Post-randomization

    Opioid requirement (in morphine equivalents) at 24 hours post-randomization

    24 hours following randomization.

  • Opioid Requirement at 48 Hours Post-randomization.

    Opioid requirement (in morphine equivalents) at 48 hours post-randomization

    48 hours following randomization.

  • Opioid Requirement at 72 Hours Post-randomization

    Opioid requirement (in morphine equivalents) at 72 hours post-randomization

    72 hours following randomization.

  • Opioid Requirement at 96 Hours Post-randomization

    Opioid requirement (in morphine equivalents) at 96 hours post-randomization

    96 hours following randomization.

Secondary Outcomes (2)

  • Development of Pneumonia

    96 hours following randomization

  • Self-reported Pain at 96 Hours Post-randomization

    At 96 hours post-randomization

Study Arms (2)

Liposomal bupivacaine

ACTIVE COMPARATOR

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

0.9% sodium chloride

PLACEBO COMPARATOR

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

Interventions

Liposomal bupivacaineDRUG

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

Liposomal bupivacaine
0.9% sodium chlorideDRUG

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

Also known as: 0.9% saline
0.9% sodium chloride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45216, United States

Location

Related Publications (1)

  • 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.

    PMID: 34789700DERIVED

MeSH Terms

Conditions

Rib Fractures

Interventions

Sodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic Injuries

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Michael Goodman
Organization
University of Cincinnati
michael.goodman@uc.edu
5135585661

Study Officials

  • Michael D Goodman, MD

    Department of Surgery, University of Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
instructor

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 25, 2016

Study Start

March 9, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

April 4, 2022

Results First Posted

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)