Blunt Chest Wall TraumaPhase 2NCT02749968
Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
A Phase 2 study testing Liposomal bupivacaine and 0.9% sodium chloride in people with Blunt Chest Wall Trauma and Rib Fracture, run by University of Cincinnati at 1 site in United States.
Trial summary
This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blunt Chest Wall Trauma, Rib Fracture, Sternal Fracture
- What is being tested?
- Liposomal bupivacaine and 0.9% sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2018to 1 Jan 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Weight < 50 kg or > 150 kg
- Pregnancy
- Incarceration
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45216
About this study
This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall trauma.
Read the 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.
- Conditions
- Blunt Chest Wall Trauma, Rib Fracture, Sternal Fracture
- Being tested
- Liposomal bupivacaine, 0.9% sodium chloride
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
0.9% sodium chlorideDrug
Also called 0.9% saline
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Requirement at 24 Hours Post-randomization
Opioid requirement (in morphine equivalents) at 24 hours post-randomization
Measured: 24 hours following randomization.
Opioid Requirement at 48 Hours Post-randomization.
Opioid requirement (in morphine equivalents) at 48 hours post-randomization
Measured: 48 hours following randomization.
Opioid Requirement at 72 Hours Post-randomization
Opioid requirement (in morphine equivalents) at 72 hours post-randomization
Measured: 72 hours following randomization.
Opioid Requirement at 96 Hours Post-randomization
Opioid requirement (in morphine equivalents) at 96 hours post-randomization
Measured: 96 hours following randomization.
Secondary outcomes (2)
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.
Measured: 96 hours following 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.
Measured: At 96 hours post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start9 Mar 2018
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blunt Chest Wall TraumaStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- United States Air Force
- Responsible party
- Principal investigator, Michael Goodman, University of Cincinnati
- Investigators
- Michael D Goodman, MD, Principal investigator, Department of Surgery, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749968
- Sponsor's protocol ID
- Droege 2016
- Status last verified
- Mar 2022
- First submitted
- 18 Apr 2016
- Last updated
- 4 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34789700
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
- ClinicalTrials.gov ID
- NCT02749968
- Acronym / sponsor ID
- Droege 2016
- Conditions
- Blunt Chest Wall Trauma, Rib Fracture, Sternal Fracture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- United States Air Force
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Posted 4 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivacaine | Active comparator | Drug: Liposomal bupivacaine1 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 | Placebo comparator | Drug: 0.9% sodium chloride1 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaine1 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 chlorideAlso: 0.9% saline1 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 |
Primary outcome
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
2 secondary outcomes
Development of Pneumonia
Time frame: 96 hours following randomization
Self-reported Pain at 96 Hours Post-randomization
Time frame: At 96 hours post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34789700Wallen 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.
- Individual participant dataSharing planned: No
Related trials for Blunt Chest Wall Trauma
Not yet recruitingObservational study
STUMBL vs TTSS in Predicting Morbidity and Mortality of Blunt Chest Trauma
Blunt Chest Wall Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Goodman, MD principal investigator
Department of Surgery, University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal bupivacaine and 0.9% sodium chloride in people with Blunt Chest Wall Trauma and Rib Fracture, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Requirement at 24 Hours Post-randomization (time frame: 24 hours following randomization.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02749968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.