xml: <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/NCT05983393</url>
    </required_header>
    <id_info>
      <org_study_id>2020/12-04</org_study_id>
      <nct_id>NCT05983393</nct_id>
    </id_info>
    <brief_title>Erector Spina Plane Block for Multilevel Major Spinal Surgery</brief_title>
    <official_title>Effect of Ultrasound-guided Bilateral Erector Spina Plan Block for Postoperative Analgesia in Patients Undergoing Multilevel Posterior Spinal Instrumentation.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kahramanmaras Sutcu Imam University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kahramanmaras Sutcu Imam 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>
        Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic&#xD;
        analgesic activity at paraspinal muscles. This study aims to examine the postoperative&#xD;
        analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postoperative patient-controlled analgesia in the ESP group and control group will be&#xD;
        compared with 24-hour morphine consumption and NRS scores at different time points. In&#xD;
        addition, the need for rescue analgesics and patient satisfaction will be evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2021</start_date>
    <completion_date type="Anticipated">August 10, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 7, 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>opioid consumption</measure>
      <time_frame>up to 24 hour</time_frame>
      <description>The amount of morphine consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Pain</condition>
    <condition>Post Operative Pain</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>No block was performed</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Erector spinae plane block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Erector spinae plane block was performed, morphine was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>control</intervention_name>
      <description>Erector spinae plane block was performed</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Erector spinae plane block</arm_group_label>
      <other_name>Erector spinae plane block</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA I-III patients&#xD;
  &#xD;
            -  Agreed to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with infection at the injection site&#xD;
  &#xD;
            -  Coagulopathy Allergy to amide-type local anesthetics&#xD;
  &#xD;
            -  History of peripheral neuropathy&#xD;
  &#xD;
            -  Hepatic and/or renal failure&#xD;
  &#xD;
            -  Refusing the procedure&#xD;
  &#xD;
            -  Patients with heart disease&#xD;
  &#xD;
            -  Patients who have previously undergone surgery from the same area&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gökce Gişi</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kahramanmaras Sutcu Imam Universty</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Gözen Öksüz</last_name>
      <role>Study Director</role>
      <affiliation>Kahramanmaras Sutcu Imam Universty</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gökce Gişi</last_name>
      <phone>05056696846</phone>
      <email>gokcegisi@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gözen Öksüz</last_name>
      <phone>05056032953</phone>
      <email>gozencoskun@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kahramanmaras Sutcu Imam University Hospital</name>
        <address>
          <city>Kahramanmaras</city>
          <zip>46100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gökce Gişi</last_name>
        <phone>05056696846</phone>
        <email>gokcegisi@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kahramanmaras Sutcu Imam University</investigator_affiliation>
      <investigator_full_name>Gökçe Gişi</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Pain</keyword>
    <keyword>postoperative analgesia</keyword>
    <keyword>Erector spinae plane block</keyword>
    <keyword>posterior spinal instrumentation</keyword>
    <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>
  
  
text: 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/NCT05983393
  org study id: 2020/12-04
  nct id: NCT05983393
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic
        analgesic activity at paraspinal muscles. This study aims to examine the postoperative
        analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation
  Postoperative patient-controlled analgesia in the ESP group and control group will be
        compared with 24-hour morphine consumption and NRS scores at different time points. In
        addition, the need for rescue analgesics and patient satisfaction will be evaluated.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Double (Care Provider, Outcomes Assessor)
  measure: opioid consumption
  time frame: up to 24 hour
  description: The amount of morphine consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.
  arm group label: Control group
  arm group type: Sham Comparator
  description: No block was performed
  arm group label: Erector spinae plane block
  arm group type: Active Comparator
  description: Erector spinae plane block was performed, morphine was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
  intervention type: Procedure
  intervention name: control
  description: Erector spinae plane block was performed
  arm group label: Control group
  arm group label: Erector spinae plane block
  other name: Erector spinae plane block
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gökce Gişi
  role: Principal Investigator
  affiliation: Kahramanmaras Sutcu Imam Universty
  last name: Gözen Öksüz
  role: Study Director
  affiliation: Kahramanmaras Sutcu Imam Universty
  last name: Gökce Gişi
  phone: 05056696846
  email: gokcegisi@gmail.com
  last name: Gözen Öksüz
  phone: 05056032953
  email: gozencoskun@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Kahramanmaras Sutcu Imam University
  investigator full name: Gökçe Gişi
  investigator title: Assistant Professor
  mesh term: Pain, Postoperative
  sharing ipd: No