<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/NCT04449367</url>
  </required_header>
  <id_info>
    <org_study_id>DSREC-04/2018_01</org_study_id>
    <nct_id>NCT04449367</nct_id>
  </id_info>
  <brief_title>ERECTOR SPINAE BLOCK AFTER THORACIC SPINE SURGERY</brief_title>
  <acronym>SPINE</acronym>
  <official_title>THE EFFECTIVENESS OF AN ULTRASOUND GUIDED RECTOR SPINAE BLOCK IN PATIENTS UNDERGOING THORACIC SPINE SURGERY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dubai Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dubai Health Authority</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>
      the effectiveness of ultrasound guided erector spinae plane block in patients undergoing&#xD;
      thoracic spine sugery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      bilateral erector spinae plane block would be given to patients with thoracic spine sugery&#xD;
      for postoperative analgesia &amp; its effectiveness would be evaluated for 2 days&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 26, 2018</start_date>
  <completion_date type="Actual">June 22, 2020</completion_date>
  <primary_completion_date type="Actual">April 22, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Days</target_duration>
  <primary_outcome>
    <measure>ultrasound guided erector spinae plane block can be used for postoperative analgesia for patients undergoing thoracic spine sugery</measure>
    <time_frame>2 days</time_frame>
    <description>postoperative analgesia</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Post Operative Analgesia</condition>
  <arm_group>
    <arm_group_label>Randomized and Single-Arm Trials</arm_group_label>
    <description>a sham comparator (no intervention)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ultrasound guided erector spinae plane block</intervention_name>
    <description>bilatral block given to patients under general anaesthesia for thoracic spine sugery to contorl post operative pain</description>
    <arm_group_label>Randomized and Single-Arm Trials</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients underging thoracic spine sugery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  postoperative thoracic spine sugery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less then 18 years&#xD;
&#xD;
          -  more than 65 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dubai Health Authority</name>
      <address>
        <city>Dubai</city>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Arab Emirates</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dubai Health Authority</investigator_affiliation>
    <investigator_full_name>Dr Manar Mamdouh Fahmy Elsharkawi</investigator_full_name>
    <investigator_title>SPECIALIST ANAESTHESIOLOGIST</investigator_title>
  </responsible_party>
  <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/NCT04449367
org study id: DSREC-04/2018_01
nct id: NCT04449367
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
the effectiveness of ultrasound guided erector spinae plane block in patients undergoing
      thoracic spine sugery
bilateral erector spinae plane block would be given to patients with thoracic spine sugery
      for postoperative analgesia & its effectiveness would be evaluated for 2 days
observational model: Cohort
time perspective: Prospective
measure: ultrasound guided erector spinae plane block can be used for postoperative analgesia for patients undergoing thoracic spine sugery
time frame: 2 days
description: postoperative analgesia
arm group label: Randomized and Single-Arm Trials
description: a sham comparator (no intervention)
intervention type: Procedure
intervention name: ultrasound guided erector spinae plane block
description: bilatral block given to patients under general anaesthesia for thoracic spine sugery to contorl post operative pain
arm group label: Randomized and Single-Arm Trials
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Arab Emirates
responsible party type: Principal Investigator
investigator affiliation: Dubai Health Authority
investigator full name: Dr Manar Mamdouh Fahmy Elsharkawi
investigator title: SPECIALIST ANAESTHESIOLOGIST
sharing ipd: No