<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03805360</url>
  </required_header>
  <id_info>
    <org_study_id>HM20014264</org_study_id>
    <nct_id>NCT03805360</nct_id>
  </id_info>
  <brief_title>The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients</brief_title>
  <official_title>The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to identify the benefits of a type of nerve block,&#xD;
      called an erector spinae plane block (ESP), in the treatment of patients with multiple rib&#xD;
      fractures and uncontrolled pain despite receiving current institutional standards of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rib fractures are one of the most common injuries secondary to blunt chest trauma, and carry&#xD;
      significant risk in terms of patient morbidity and mortality. Pulmonary complications&#xD;
      resulting from these injuries include severe atelectasis with hypoxemia, pneumonia, pleural&#xD;
      effusions, respiratory distress syndrome, need for mechanical ventilation and ICU admission,&#xD;
      and prolonged hospital stay. Many institutions have tried to develop protocols to risk&#xD;
      stratify and appropriately treat these patients, with the goal of predicting those with&#xD;
      higher likelihood of pulmonary complications in order to minimize additional morbidity.&#xD;
      Studies have demonstrated critical spirometry values which correlate to worse patient&#xD;
      outcomes; specifically, vital capacity less than 50% predicted, or less than 2L.&#xD;
      Subsequently, there have been numerous attempts to identify the best treatment interventions&#xD;
      for these high risk patients. In addition to multi-modal pain management, the most commonly&#xD;
      used procedures include thoracic epidurals, continuous or single shot paravertebral blocks,&#xD;
      and intercostal blocks. However, all of the above interventions carry significant risk, and&#xD;
      the frequent use lovenox thromboprophylaxis drastically limit their use. Recently, a novel&#xD;
      peripheral nerve block technique has been developed, an erector spinae plane block (ESP),&#xD;
      which may provide similar or greater efficacy to the above, with significantly less risk to&#xD;
      the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">May 24, 2019</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">January 10, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study aims to assess the systemic absorption of ropivacaine when it is administered into the erector spinae plane compartment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in numeric pain score rating at rest (before incentive spirometry exercise)</measure>
    <time_frame>Baseline and at 45 minutes after ESP block</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in numeric pain score rating with respiration (after incentive spirometry exercise)</measure>
    <time_frame>Baseline and at 45 minutes after ESP block</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in incentive spirometry values</measure>
    <time_frame>Baseline and at 45 minutes after ESP block</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Rib Fractures</condition>
  <arm_group>
    <arm_group_label>ESP block with normal saline</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESP block with local anesthetic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An erector spinae plane block will be performed and a single dose of 0.5% ropivacaine will be injected into the target muscle plane.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Ropivacaine is a local anesthetic that is expected to provide numbness to the chest wall when injected into the erector spinae plane.</description>
    <arm_group_label>ESP block with local anesthetic</arm_group_label>
    <other_name>Local anesthetic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline Flush, 0.9% Injectable Solution</intervention_name>
    <description>Normal Saline Flush, 0.9% Injectable Solution is not expected to provide numbness to the chest wall when injected into the erector spinae plane.</description>
    <arm_group_label>ESP block with normal saline</arm_group_label>
    <other_name>0.9% Sodium Chloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Blunt chest trauma&#xD;
&#xD;
          -  Sustaining at least 3 unliateral rib fractures&#xD;
&#xD;
          -  Resultant vital capacity less than 30% predicted&#xD;
&#xD;
          -  Pain score reaches threshold despite using the current institutional standard of care&#xD;
             for pain control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whose weight less than 60kg.&#xD;
&#xD;
          -  Patients with bilateral rib fractures.&#xD;
&#xD;
          -  Patients that are intubated and mechanically ventilated.&#xD;
&#xD;
          -  Pregnant Individuals.&#xD;
&#xD;
          -  Any individual with a documented allergy to ropivacaine.&#xD;
&#xD;
          -  Patients with limited English proficiency (LEP)&#xD;
&#xD;
          -  Patients whose body habitus prevents the practitioner's ability to adequately perform&#xD;
             the procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bryant Tran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Rib Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT03805360/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03805360
org study id: HM20014264
nct id: NCT03805360
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study aims to assess the systemic absorption of ropivacaine when it is administered into the erector spinae plane compartment.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in numeric pain score rating at rest (before incentive spirometry exercise)
time frame: Baseline and at 45 minutes after ESP block
description: 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)
measure: Change in numeric pain score rating with respiration (after incentive spirometry exercise)
time frame: Baseline and at 45 minutes after ESP block
description: 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)
measure: Change in incentive spirometry values
time frame: Baseline and at 45 minutes after ESP block
description: 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.
arm group label: ESP block with normal saline
arm group type: Sham Comparator
description: 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.
arm group label: ESP block with local anesthetic
arm group type: Experimental
description: An erector spinae plane block will be performed and a single dose of 0.5% ropivacaine will be injected into the target muscle plane.
intervention type: Drug
intervention name: Ropivacaine
description: Ropivacaine is a local anesthetic that is expected to provide numbness to the chest wall when injected into the erector spinae plane.
arm group label: ESP block with local anesthetic
other name: Local anesthetic
intervention type: Drug
intervention name: Normal Saline Flush, 0.9% Injectable Solution
description: Normal Saline Flush, 0.9% Injectable Solution is not expected to provide numbness to the chest wall when injected into the erector spinae plane.
arm group label: ESP block with normal saline
other name: 0.9% Sodium Chloride
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bryant Tran, MD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Rib Fractures
mesh term: Ropivacaine
mesh term: Anesthetics, Local
mesh term: Anesthetics
provided document: 