<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/NCT03767816</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1320</org_study_id>
    <nct_id>NCT03767816</nct_id>
  </id_info>
  <brief_title>The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy</brief_title>
  <official_title>The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <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 was to investigate the effectiveness of erector spinae plane block&#xD;
      on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus&#xD;
      sheath block may provide sufficient somatic pain block, investigators aimed to investigate&#xD;
      whether erector spinae block is effective in visceral pain block.&#xD;
&#xD;
      After induction of general anesthesia, group of patient is decided randomly. In Group R,&#xD;
      rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group&#xD;
      RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine&#xD;
      70ml before the operation.&#xD;
&#xD;
      NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12,&#xD;
      18, and 24 hours after arrival at the recovery room were collected&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of analgesic consumption between both group</measure>
    <time_frame>at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation</time_frame>
    <description>The difference in analgesics usage between the two groups after the operation is checked at fixed intervals (at 0, 0.5,&#xD;
1, 2, 6, 12, 18, 24 hours after operation) to compare.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>compare the Numeric rating scale (NRS)</measure>
    <time_frame>at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation</time_frame>
    <description>10 years old or older. 0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable.&#xD;
After surgery, the NRS differences between the two groups were compared at a constant interval (0, 0.5, 1, 2, 6, 12, 18, 24 hours postoperatively).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Visceral Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Group R : Rectus sheath block group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group RE: Rectus sheath block and erector spinae plane block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ultrasound guided Rectus sheath block</intervention_name>
    <description>Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus</description>
    <arm_group_label>Group R : Rectus sheath block group</arm_group_label>
    <arm_group_label>Group RE: Rectus sheath block and erector spinae plane block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ultrasound erector spinae plane block</intervention_name>
    <description>Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level</description>
    <arm_group_label>Group RE: Rectus sheath block and erector spinae plane block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. adults between the ages of 20 and 80&#xD;
&#xD;
          2. scheduled laparoscopic cholecystectomy patient&#xD;
&#xD;
          3. American society of anesthesiologists score 1 or 2&#xD;
&#xD;
          4. Patients who have voluntarily agreed in writing to participate in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with side effects on local anesthetics or steroids&#xD;
&#xD;
          2. Patient who are taboo of peripheral nerve block such as blood clotting disorder,&#xD;
             infection, etc.&#xD;
&#xD;
          3. Patients with uncontrolled medical or psychiatric problem&#xD;
&#xD;
          4. Patient does not agree to participate in the study&#xD;
&#xD;
          5. Patients with deformity at vertebra or chest wall.&#xD;
&#xD;
          6. Patients who are pregnant or lactating&#xD;
&#xD;
          7. Patients receiving a single laparoscopic cholecystectomy (including using a robot)&#xD;
&#xD;
          8. Patients with severe intraperitoneal adhesion (higher than Nair s grade 3), or with&#xD;
             external drain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JongHyuk Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Songpa-gu</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Jong Hyuk Lee</investigator_full_name>
    <investigator_title>clinical assistant professor</investigator_title>
  </responsible_party>
  <keyword>laparoscopic cholecystectomy</keyword>
  <keyword>erector spinae plane block</keyword>
  <keyword>visceral pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Visceral Pain</mesh_term>
  </condition_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/NCT03767816
org study id: 2018-1320
nct id: NCT03767816
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to investigate the effectiveness of erector spinae plane block
      on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus
      sheath block may provide sufficient somatic pain block, investigators aimed to investigate
      whether erector spinae block is effective in visceral pain block.

      After induction of general anesthesia, group of patient is decided randomly. In Group R,
      rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group
      RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine
      70ml before the operation.

      NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12,
      18, and 24 hours after arrival at the recovery room were collected
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Difference of analgesic consumption between both group
time frame: at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation
description: The difference in analgesics usage between the two groups after the operation is checked at fixed intervals (at 0, 0.5,
1, 2, 6, 12, 18, 24 hours after operation) to compare.
measure: compare the Numeric rating scale (NRS)
time frame: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation
description: 10 years old or older. 0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable.
After surgery, the NRS differences between the two groups were compared at a constant interval (0, 0.5, 1, 2, 6, 12, 18, 24 hours postoperatively).
arm group label: Group R : Rectus sheath block group
arm group type: Experimental
description: ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision
arm group label: Group RE: Rectus sheath block and erector spinae plane block
arm group type: Active Comparator
description: ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml
intervention type: Drug
intervention name: Ultrasound guided Rectus sheath block
description: Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus
arm group label: Group R : Rectus sheath block group
arm group label: Group RE: Rectus sheath block and erector spinae plane block
intervention type: Drug
intervention name: Ultrasound erector spinae plane block
description: Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level
arm group label: Group RE: Rectus sheath block and erector spinae plane block
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: JongHyuk Lee, MD
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Jong Hyuk Lee
investigator title: clinical assistant professor
mesh term: Pain, Postoperative
mesh term: Visceral Pain