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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Normal Saline Flush, 0.9% Injectable Solution
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:
  • 0.9% Sodium Chloride
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.
Drug: Ropivacaine
Ropivacaine is a local anesthetic that is expected to provide numbness to the chest wall when injected into the erector spinae plane.
Other Names:
  • Local anesthetic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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)
Baseline and at 45 minutes after ESP block
Change in numeric pain score rating with respiration (after incentive spirometry exercise)
Time Frame: Baseline and at 45 minutes after ESP block
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
Change in incentive spirometry values
Time Frame: Baseline and at 45 minutes after ESP block
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.
Baseline and at 45 minutes after ESP block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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