- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03805360
The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients
August 5, 2020 updated by: Virginia Commonwealth University
The purpose of this research study is to identify the benefits of a type of nerve block, called an erector spinae plane block (ESP), in the treatment of patients with multiple rib fractures and uncontrolled pain despite receiving current institutional standards of care.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Rib fractures are one of the most common injuries secondary to blunt chest trauma, and carry significant risk in terms of patient morbidity and mortality.
Pulmonary complications resulting from these injuries include severe atelectasis with hypoxemia, pneumonia, pleural effusions, respiratory distress syndrome, need for mechanical ventilation and ICU admission, and prolonged hospital stay.
Many institutions have tried to develop protocols to risk stratify and appropriately treat these patients, with the goal of predicting those with higher likelihood of pulmonary complications in order to minimize additional morbidity.
Studies have demonstrated critical spirometry values which correlate to worse patient outcomes; specifically, vital capacity less than 50% predicted, or less than 2L.
Subsequently, there have been numerous attempts to identify the best treatment interventions for these high risk patients.
In addition to multi-modal pain management, the most commonly used procedures include thoracic epidurals, continuous or single shot paravertebral blocks, and intercostal blocks.
However, all of the above interventions carry significant risk, and the frequent use lovenox thromboprophylaxis drastically limit their use.
Recently, a novel peripheral nerve block technique has been developed, an erector spinae plane block (ESP), which may provide similar or greater efficacy to the above, with significantly less risk to the patient.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Blunt chest trauma
- Sustaining at least 3 unliateral rib fractures
- Resultant vital capacity less than 30% predicted
- Pain score reaches threshold despite using the current institutional standard of care for pain control
Exclusion Criteria:
- Patients whose weight less than 60kg.
- Patients with bilateral rib fractures.
- Patients that are intubated and mechanically ventilated.
- Pregnant Individuals.
- Any individual with a documented allergy to ropivacaine.
- Patients with limited English proficiency (LEP)
- Patients whose body habitus prevents the practitioner's ability to adequately perform the procedure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: ESP block with normal saline
An erector spinae plane block will be performed and a single dose of Normal Saline Flush, 0.9% Injectable Solution will be administered into the target muscle plane.
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Normal Saline Flush, 0.9% Injectable Solution is not expected to provide numbness to the chest wall when injected into the erector spinae plane.
Other Names:
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Experimental: ESP block with local anesthetic
An erector spinae plane block will be performed and a single dose of 0.5% ropivacaine will be injected into the target muscle plane.
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Ropivacaine is a local anesthetic that is expected to provide numbness to the chest wall when injected into the erector spinae plane.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in numeric pain score rating at rest (before incentive spirometry exercise)
Time Frame: Baseline and at 45 minutes after ESP block
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Self-reported pain intensity before the ESP block is performed and after the ESP block is performed.
These measurements will be assessed before the incentive spirometry exercise.
Each item is scored 0-10 (0 = no pain; 10= worst pain possible)
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Baseline and at 45 minutes after ESP block
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Change in numeric pain score rating with respiration (after incentive spirometry exercise)
Time Frame: Baseline and at 45 minutes after ESP block
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Self-reported pain intensity before the ESP block is performed and after the ESP block is performed.
These measurements will be assessed after the incentive spirometry exercise.
Each item is scored 0-10 (0 = no pain; 10 = worst pain possible)
|
Baseline and at 45 minutes after ESP block
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Change in incentive spirometry values
Time Frame: Baseline and at 45 minutes after ESP block
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Incentive spirometry values, measured in cubic centimeters, when the participant provides one inhalational breath at maximum effort.
The first measurement will be taken before the ESP block procedure and the second measurement 45 minutes after the ESP block procedure.
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Baseline and at 45 minutes after ESP block
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bryant Tran, MD, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 24, 2019
Primary Completion (Actual)
January 10, 2020
Study Completion (Actual)
January 10, 2020
Study Registration Dates
First Submitted
January 10, 2019
First Submitted That Met QC Criteria
January 14, 2019
First Posted (Actual)
January 15, 2019
Study Record Updates
Last Update Posted (Actual)
August 7, 2020
Last Update Submitted That Met QC Criteria
August 5, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20014264
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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