<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/NCT03781687</url>
  </required_header>
  <id_info>
    <org_study_id>KIA 2018/488</org_study_id>
    <nct_id>NCT03781687</nct_id>
  </id_info>
  <brief_title>Bilateral vs. Unilateral Erector Spinae Plane Block</brief_title>
  <official_title>Bilateral vs. Unilateral Erector Spinae Plane Block for Laparoscopic Cholecystectomy; A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli 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 importance of multimodal analgesia for postoperative pain management is well known and&#xD;
      regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector&#xD;
      spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But&#xD;
      two injections can be unconfortable for some patients. With this study, we aimed to compare&#xD;
      the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">June 29, 2019</completion_date>
  <primary_completion_date type="Actual">June 28, 2019</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>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine consumption</measure>
    <time_frame>preoperative 24th hour</time_frame>
    <description>Morphine consumption will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numeric Rating Scale</measure>
    <time_frame>postoperative 24th hour</time_frame>
    <description>A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Cholecystitis; Gallstone</condition>
  <arm_group>
    <arm_group_label>Bilateral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bilateral ESP block will be performed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unilateral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Unilateral ESP block will be performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral ESP Block</intervention_name>
    <description>Bilateral ESP Block will be performed at T8</description>
    <arm_group_label>Bilateral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Unilateral ESP Block</intervention_name>
    <description>Unilateral ESP Block will be performed at T8 (right side)</description>
    <arm_group_label>Unilateral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intravenous Morphine patient controlled analgesia device</intervention_name>
    <description>24 hour morphine consumption will be recorded</description>
    <arm_group_label>Bilateral</arm_group_label>
    <arm_group_label>Unilateral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II patients&#xD;
&#xD;
          -  Pateints undergoing elective laparoscopic cholecystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  obesity (body mass index &gt;35 kg/m2)&#xD;
&#xD;
          -  infection of the skin at the site of needle puncture area&#xD;
&#xD;
          -  patients with known allergies to any of the study drugs&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  recent use of analgesic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Can Aksu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kocaeli Üniversitesi Tıp Fakültesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kocaeli University Hospital</name>
      <address>
        <city>İzmit</city>
        <state>Kocaeli</state>
        <zip>41340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>November 21, 2019</last_update_submitted>
  <last_update_submitted_qc>November 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli University</investigator_affiliation>
    <investigator_full_name>Can AKSU</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>erector spinae plane block</keyword>
  <keyword>postoperative pain</keyword>
  <keyword>laparoscopic cholecystectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Gallstones</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
  </intervention_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/NCT03781687
org study id: KIA 2018/488
nct id: NCT03781687
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The importance of multimodal analgesia for postoperative pain management is well known and
      regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector
      spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But
      two injections can be unconfortable for some patients. With this study, we aimed to compare
      the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Care Provider, Outcomes Assessor)
measure: Morphine consumption
time frame: preoperative 24th hour
description: Morphine consumption will be recorded
measure: Numeric Rating Scale
time frame: postoperative 24th hour
description: A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.
arm group label: Bilateral
arm group type: Active Comparator
description: Bilateral ESP block will be performed
arm group label: Unilateral
arm group type: Active Comparator
description: Unilateral ESP block will be performed
intervention type: Procedure
intervention name: Bilateral ESP Block
description: Bilateral ESP Block will be performed at T8
arm group label: Bilateral
intervention type: Procedure
intervention name: Unilateral ESP Block
description: Unilateral ESP Block will be performed at T8 (right side)
arm group label: Unilateral
intervention type: Device
intervention name: Intravenous Morphine patient controlled analgesia device
description: 24 hour morphine consumption will be recorded
arm group label: Bilateral
arm group label: Unilateral
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Can Aksu
role: Principal Investigator
affiliation: Kocaeli Üniversitesi Tıp Fakültesi
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kocaeli University
investigator full name: Can AKSU
investigator title: Assistant Professor
mesh term: Cholecystitis
mesh term: Gallstones
mesh term: Pain, Postoperative
mesh term: Morphine
sharing ipd: No