<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/NCT03237546</url>
  </required_header>
  <id_info>
    <org_study_id>17-00070</org_study_id>
    <nct_id>NCT03237546</nct_id>
  </id_info>
  <brief_title>The Use of Serratus Block for Cardiac Surgery</brief_title>
  <official_title>The Use of Serratus Block for Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized, un-blinded study is to determine if serratus blocks or&#xD;
      Patient Controlled Analgesia (PCA)-alone (no block) offer patients adequate pain relief. This&#xD;
      study will compare two standard of care pain management options and the patients narcotic&#xD;
      requirements in the immediate postoperative period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Actual">November 13, 2017</completion_date>
  <primary_completion_date type="Actual">November 13, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of intravenous opiates used during the immediate postoperative period</measure>
    <time_frame>24 Hours</time_frame>
    <description>The primary endpoint of the study will be comparison of the amount of intravenous opiates used during the immediate postoperative period between the 2 groups, the group receiving general anesthesia with the serratus block and the group receiving general anesthesia alone.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>Serratus blocks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The serratus plane is interstitial tissue, below the serratus muscle. The injection of bupivacaine numbs the anterior branch of the thoracodorsal nerve. This technique allows for the medication to diffuse along the area of the serratus plane to provide numbing of that area. Upon completion of the block, the patient will be evaluated for extubation and emerged from general anesthesia if appropriate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCA-alone (no block)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All subjects will receive fentanyl intravenous patient controlled anesthesia pumps as part of standard care. The amount of fentanyl self-administered by the patient or given by a clinician during 24 hours following surgery will be compared amongst the two groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anesthetic regimen including SB</intervention_name>
    <description>Group receiving general anesthesia with the serratus block</description>
    <arm_group_label>Serratus blocks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anesthetic regimen including SB or no block</intervention_name>
    <description>Group receiving general anesthesia alone</description>
    <arm_group_label>PCA-alone (no block)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over the age of 18 years of age undergoing robotic cardiac surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not candidates for serratus block&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennie Ngai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>March 28, 2018</last_update_submitted>
  <last_update_submitted_qc>March 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Robotic Cardiac Surgery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03237546
org study id: 17-00070
nct id: NCT03237546
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this randomized, un-blinded study is to determine if serratus blocks or
      Patient Controlled Analgesia (PCA)-alone (no block) offer patients adequate pain relief. This
      study will compare two standard of care pain management options and the patients narcotic
      requirements in the immediate postoperative period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Amount of intravenous opiates used during the immediate postoperative period
time frame: 24 Hours
description: The primary endpoint of the study will be comparison of the amount of intravenous opiates used during the immediate postoperative period between the 2 groups, the group receiving general anesthesia with the serratus block and the group receiving general anesthesia alone.
arm group label: Serratus blocks
arm group type: Active Comparator
description: The serratus plane is interstitial tissue, below the serratus muscle. The injection of bupivacaine numbs the anterior branch of the thoracodorsal nerve. This technique allows for the medication to diffuse along the area of the serratus plane to provide numbing of that area. Upon completion of the block, the patient will be evaluated for extubation and emerged from general anesthesia if appropriate.
arm group label: PCA-alone (no block)
arm group type: Active Comparator
description: All subjects will receive fentanyl intravenous patient controlled anesthesia pumps as part of standard care. The amount of fentanyl self-administered by the patient or given by a clinician during 24 hours following surgery will be compared amongst the two groups.
intervention type: Procedure
intervention name: Anesthetic regimen including SB
description: Group receiving general anesthesia with the serratus block
arm group label: Serratus blocks
intervention type: Procedure
intervention name: Anesthetic regimen including SB or no block
description: Group receiving general anesthesia alone
arm group label: PCA-alone (no block)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Jennie Ngai, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anesthetics
sharing ipd: Undecided