<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/NCT04420104</url>
  </required_header>
  <id_info>
    <org_study_id>AMU</org_study_id>
    <nct_id>NCT04420104</nct_id>
  </id_info>
  <brief_title>Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial</brief_title>
  <official_title>Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aydin Adnan Menderes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aydin Adnan Menderes University</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>
      The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for&#xD;
      postoperative pain management in cardiac surgery patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed about the study and potential risks, all patients giving written&#xD;
      informed consent will be randomised (single blind) as block group(patients is performed esp&#xD;
      block) and control group. All patients will be evaluate during 48 hours for postoperative&#xD;
      pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline in pain the 10 point Visual Analog Scale (VAS) at hours 3,6,9,12,24,36,48.</measure>
    <time_frame>baseline and hours 3-6-12-24-36-48</time_frame>
    <description>The VAS is validated instrument assessing average pain. Possible scores range from 0 (no pain) to 10 (worst possible pain) Change= (hours 3,6,9,12,24,48 score- baseline)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time to mobilize the patient</measure>
    <time_frame>Any time for 7 days</time_frame>
    <description>time to mobilize the patient is reported as when the patient is mobilized</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Erector Spinae Plane Block</condition>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>esp block group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>erector spinae plane block</intervention_name>
    <description>ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.</description>
    <arm_group_label>esp block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>iv analgesia</intervention_name>
    <description>iv contromal</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>esp block group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be ASA score I-III&#xD;
&#xD;
          -  Must be 18-75 years old&#xD;
&#xD;
          -  must undergo cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency surgery,&#xD;
&#xD;
          -  bleeding diathesis,&#xD;
&#xD;
          -  presence of contraindications to LA agents used in this study,&#xD;
&#xD;
          -  use of chronic opioids,&#xD;
&#xD;
          -  psychiatric disorders.&#xD;
&#xD;
          -  prolonged extubation&#xD;
&#xD;
          -  presence of infection at the injection site.&#xD;
&#xD;
          -  cardiovascular conditions (EF&lt;40, LMCA obstruction)&#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>Sinem Sari, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Adnan Menderes University Medical Faculty Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sinem Sari, Assoc Prof</last_name>
    <phone>90 507 539 63 13</phone>
    <email>sarisinem@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department</name>
      <address>
        <city>Aydın</city>
        <zip>09100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>sinem sari</last_name>
      <phone>090 4441256-2108</phone>
      <email>sarisinem@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Pelin Dilsiz</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nil Kaan</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Erdem Ali Ozkisacik</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tunay Kurtoglu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Varlik Erel</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.</citation>
    <PMID>30052229</PMID>
  </reference>
  <reference>
    <citation>Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4. Erratum In: J Cardiothorac Vasc Anesth. 2022 Feb;36(2):627.</citation>
    <PMID>30055991</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aydin Adnan Menderes University</investigator_affiliation>
    <investigator_full_name>SINEM SARI</investigator_full_name>
    <investigator_title>Assoc. Prof. Dr.</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>
  <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/NCT04420104
org study id: AMU
nct id: NCT04420104
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for
      postoperative pain management in cardiac surgery patients.
After being informed about the study and potential risks, all patients giving written
      informed consent will be randomised (single blind) as block group(patients is performed esp
      block) and control group. All patients will be evaluate during 48 hours for postoperative
      pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: change from baseline in pain the 10 point Visual Analog Scale (VAS) at hours 3,6,9,12,24,36,48.
time frame: baseline and hours 3-6-12-24-36-48
description: The VAS is validated instrument assessing average pain. Possible scores range from 0 (no pain) to 10 (worst possible pain) Change= (hours 3,6,9,12,24,48 score- baseline)
measure: time to mobilize the patient
time frame: Any time for 7 days
description: time to mobilize the patient is reported as when the patient is mobilized
arm group label: esp block group
arm group type: Experimental
arm group label: control group
arm group type: Active Comparator
intervention type: Procedure
intervention name: erector spinae plane block
description: ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
arm group label: esp block group
intervention type: Drug
intervention name: iv analgesia
description: iv contromal
arm group label: control group
arm group label: esp block group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Sinem Sari, Assoc Prof
role: Principal Investigator
affiliation: Adnan Menderes University Medical Faculty Hospital
last name: Sinem Sari, Assoc Prof
phone: 90 507 539 63 13
email: sarisinem@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Turkey
citation: Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
PMID: 30052229
citation: Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4. Erratum In: J Cardiothorac Vasc Anesth. 2022 Feb;36(2):627.
PMID: 30055991
responsible party type: Principal Investigator
investigator affiliation: Aydin Adnan Menderes University
investigator full name: SINEM SARI
investigator title: Assoc. Prof. Dr.
mesh term: Pain, Postoperative
sharing ipd: No