<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/NCT03825068</url>
  </required_header>
  <id_info>
    <org_study_id>RRLL</org_study_id>
    <nct_id>NCT03825068</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane Block in Minimal Invasive Cardiac Surgery</brief_title>
  <official_title>Erector Spinae Plane Block in Minimal Invasive Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Studying the effect of erector spinae plane block in patients undergoing minimal invasive&#xD;
      cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>48 hours</time_frame>
    <description>PAIN SCORES OF PATIENTS</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>ESP block group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients receive ESP Bock with local anaesthetics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>general anaestesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ESP Block</intervention_name>
    <description>20 ml of lacal anaesthetics will be placed below the erector spinae muscle under ultrasound guide</description>
    <arm_group_label>ESP block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>general anesthetic</intervention_name>
    <description>patient receive general anaesthetic only</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective valve replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chroic renal failure&#xD;
&#xD;
          -  chronic liver failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>rasha hamed, lecturer</last_name>
    <phone>01000440773</phone>
    <email>rashaahmed11@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>mohammed Ali Ahmed, MD</last_name>
      <email>amira_salem2015@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Rasha Hamed</investigator_full_name>
    <investigator_title>lecturer of anaesthesia and pain management</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Anesthetics, General</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03825068
org study id: RRLL
nct id: NCT03825068
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Studying the effect of erector spinae plane block in patients undergoing minimal invasive
      cardiac surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: VAS
time frame: 48 hours
description: PAIN SCORES OF PATIENTS
arm group label: ESP block group
arm group type: Active Comparator
description: patients receive ESP Bock with local anaesthetics
arm group label: control group
arm group type: Placebo Comparator
description: general anaestesia
intervention type: Procedure
intervention name: ESP Block
description: 20 ml of lacal anaesthetics will be placed below the erector spinae muscle under ultrasound guide
arm group label: ESP block group
intervention type: Drug
intervention name: general anesthetic
description: patient receive general anaesthetic only
arm group label: control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: rasha hamed, lecturer
phone: 01000440773
email: rashaahmed11@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Rasha Hamed
investigator title: lecturer of anaesthesia and pain management
mesh term: Pain, Postoperative
mesh term: Anesthetics
mesh term: Anesthetics, General