<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/NCT03785392</url>
  </required_header>
  <id_info>
    <org_study_id>17-0121</org_study_id>
    <nct_id>NCT03785392</nct_id>
  </id_info>
  <brief_title>Out of Plane Approach for Interscalene</brief_title>
  <official_title>Out of Plane Approach for Interscalene Level Brachial Plexus Block to Avoid Phrenic Nerve Involvement - a Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study aims to examine the influence of out of plane interscalene approach to a brachial&#xD;
      plexus block on the effect of phrenic nerve blockade.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have proven that there is 100% blockade of the phrenic nerve with the in-plane&#xD;
      approach to the interscalene brachial plexus block. The patient population with pulmonary&#xD;
      comorbidities with poor reserve cannot afford to have a further deterioration of their&#xD;
      pulmonary status due to phrenic nerve blockade. These patients are not ideal candidates for&#xD;
      increased opiate therapy for intraoperative and post-surgical pain as well due to further&#xD;
      depression of their respiratory function. To optimize their pain control as well as avoid any&#xD;
      respiratory-related morbidity and mortality, it is ideal to develop a technique which can&#xD;
      provide appropriate brachial plexus block at the interscalene level while completely avoiding&#xD;
      any local anesthetic spread to the phrenic nerve.&#xD;
&#xD;
      The study aims to examine the influence of out of plane interscalene approach to a brachial&#xD;
      plexus block on the effect of phrenic nerve blockade. Practitioner preference and&#xD;
      institutional norms often influence the in plane approach for the above-mentioned block. The&#xD;
      most common practice at our institution is the in plane approach to the brachial plexus&#xD;
      block.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Primary investigator left the Institution&#xD;
  </why_stopped>
  <start_date type="Actual">March 29, 2019</start_date>
  <completion_date type="Actual">December 8, 2019</completion_date>
  <primary_completion_date type="Actual">December 8, 2019</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Forced Expiratory Volume (FEV1)</measure>
    <time_frame>The change in Forced Expiratory Volume in one second (FEV1) from Baseline to 15 minutes</time_frame>
    <description>Forced Expiratory Volume in one second (FEV1) is measured in liters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Forced Vital Capacity (FVC)</measure>
    <time_frame>The change in Forced Vital Capacity (FVC) from Baseline to 15 minutes</time_frame>
    <description>Forced Vital Capacity (FVC) is measured in liters.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Acute Pain</condition>
  <condition>Brachial Plexus Block</condition>
  <arm_group>
    <arm_group_label>Group 1 Inplane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study with the technique Inplane group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 out of plane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study with the technique out of plane</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group 1 In-plane</intervention_name>
    <description>Group 1: Study will involve total of 15 patients with the procedure done in-plane. Before the block placement and after the block placement lung function will be measured.&#xD;
FEV1 (forced expiratory volume in 1 second ) and FVC ( forced vital Capacity ) values will be recorded. Block will be performed in plane and postprocedure lung function test will be repeated. New values of FEV1 and FVC will be obtained after the placement of the nerve block.</description>
    <arm_group_label>Group 1 Inplane</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group 2 out of plane</intervention_name>
    <description>Group 2 study will adopt the out of plane technique and will involve a total of 15 patients in this group. We will do the procedure out of plane and will have lung function FEV1 and FVC measured bedside.FEV1 and FVC values will be recorded. Block will be performed out of plane and postprocedure lung function test will be measured. New values of FEV1 and FVC will be obtained</description>
    <arm_group_label>Group 2 out of plane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients(18-85 years old)&#xD;
&#xD;
          -  Scheduled for elective shoulder surgery who would benefit from a preoperative&#xD;
             interscalene approach to the brachial plexus block for intraoperative and&#xD;
             postoperative pain relief.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any distorted anatomy for whom the block cannot be performed accurately,&#xD;
             such as scars, surgical fixtures at the site, active infection, any open wound or&#xD;
             drains at the site.&#xD;
&#xD;
          -  Patients who request benzodiazepine anxiolytics such as midazolam for premedication&#xD;
             before the procedure. Also patients who request narcotic medications as premedication&#xD;
             before the procedure&#xD;
&#xD;
          -  Non-English and Non-Spanish speaking patients&#xD;
&#xD;
          -  Inadequate or failed blocks and inadvertently intrathecal or intravascular injection&#xD;
             will be dropped from the study&#xD;
&#xD;
          -  Incarcerated patients&#xD;
&#xD;
          -  Expected heavy bleeding on multiple anticoagulants with markedly elevated PT (&#xD;
             Prothrombin time ), INR (International Normalized Ratio ), PTT ( Partial&#xD;
             Thromboplastin Time ) levels and markedly reduced platelet counts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ranganathan Govindaraj, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTMB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UTMB</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UTMB</name>
      <address>
        <city>League City</city>
        <state>Texas</state>
        <zip>77573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 1, 2020</last_update_submitted>
  <last_update_submitted_qc>December 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 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>Acute Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03785392
org study id: 17-0121
nct id: NCT03785392
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study aims to examine the influence of out of plane interscalene approach to a brachial
      plexus block on the effect of phrenic nerve blockade.
Studies have proven that there is 100% blockade of the phrenic nerve with the in-plane
      approach to the interscalene brachial plexus block. The patient population with pulmonary
      comorbidities with poor reserve cannot afford to have a further deterioration of their
      pulmonary status due to phrenic nerve blockade. These patients are not ideal candidates for
      increased opiate therapy for intraoperative and post-surgical pain as well due to further
      depression of their respiratory function. To optimize their pain control as well as avoid any
      respiratory-related morbidity and mortality, it is ideal to develop a technique which can
      provide appropriate brachial plexus block at the interscalene level while completely avoiding
      any local anesthetic spread to the phrenic nerve.

      The study aims to examine the influence of out of plane interscalene approach to a brachial
      plexus block on the effect of phrenic nerve blockade. Practitioner preference and
      institutional norms often influence the in plane approach for the above-mentioned block. The
      most common practice at our institution is the in plane approach to the brachial plexus
      block.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Forced Expiratory Volume (FEV1)
time frame: The change in Forced Expiratory Volume in one second (FEV1) from Baseline to 15 minutes
description: Forced Expiratory Volume in one second (FEV1) is measured in liters.
measure: Forced Vital Capacity (FVC)
time frame: The change in Forced Vital Capacity (FVC) from Baseline to 15 minutes
description: Forced Vital Capacity (FVC) is measured in liters.
arm group label: Group 1 Inplane
arm group type: Active Comparator
description: Study with the technique Inplane group
arm group label: Group 2 out of plane
arm group type: Active Comparator
description: Study with the technique out of plane
intervention type: Procedure
intervention name: Group 1 In-plane
description: Group 1: Study will involve total of 15 patients with the procedure done in-plane. Before the block placement and after the block placement lung function will be measured.
FEV1 (forced expiratory volume in 1 second ) and FVC ( forced vital Capacity ) values will be recorded. Block will be performed in plane and postprocedure lung function test will be repeated. New values of FEV1 and FVC will be obtained after the placement of the nerve block.
arm group label: Group 1 Inplane
intervention type: Procedure
intervention name: Group 2 out of plane
description: Group 2 study will adopt the out of plane technique and will involve a total of 15 patients in this group. We will do the procedure out of plane and will have lung function FEV1 and FVC measured bedside.FEV1 and FVC values will be recorded. Block will be performed out of plane and postprocedure lung function test will be measured. New values of FEV1 and FVC will be obtained
arm group label: Group 2 out of plane
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ranganathan Govindaraj, MD
role: Principal Investigator
affiliation: UTMB
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Pain
sharing ipd: No