<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/NCT02219542</url>
  </required_header>
  <id_info>
    <org_study_id>20140804</org_study_id>
    <nct_id>NCT02219542</nct_id>
  </id_info>
  <brief_title>Cytokines of Patients With Transversus Abdominis Plane Block After Laparoscopic Colonic Surgery</brief_title>
  <official_title>Cytokines of Patients After Laparoscopic Colonic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators designed a study to determine whether with combined general-transversus&#xD;
      abdominis plane block anesthesia or standard general anaesthetic would provide same level of&#xD;
      cytokines in patients undergoing Laparoscopic Colonic Surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators designed a study to determine whether combined general-transversus&#xD;
      abdominis plane block anesthesia or standard general anaesthetic would provide same level of&#xD;
      cytokine in patients undergoing Laparoscopic Colonic Surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of cytokine level in plasma samples</measure>
    <time_frame>just after anesthesia induction ; at the end of the surgery; 24h after surgery</time_frame>
    <description>The blood samples were collected before induction of anesthesia and at the end of surgery.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Laparoscopic Colonic Surgery</condition>
  <arm_group>
    <arm_group_label>a standard general anesthesia</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>a standard general anesthesia and with transversus abdominis plane block 20 ml 0.9% sodium chloride</description>
  </arm_group>
  <arm_group>
    <arm_group_label>transversus abdominis plane block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a standard general anesthesia with transversus abdominis plane block 20 mL 0.25% ropivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>transversus abdominis plane block</intervention_name>
    <description>transversus abdominis plane block with 20 mL saline</description>
    <arm_group_label>a standard general anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>transversus abdominis plane block</intervention_name>
    <description>transversus abdominis plane block with 20 mL 0.25% ropivacaine</description>
    <arm_group_label>transversus abdominis plane block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  •Participants were deemed eligible if they were candidates for spinal anesthesia&#xD;
             undergoing Laparoscopic Colonic Surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  •Existing cognitive impairment as evidenced by Mini-Mental State Examination scores&#xD;
             below 24 (of the 30 possible points)&#xD;
&#xD;
               -  A history of neurological and psychiatric diseases including stroke, and&#xD;
                  psychosis&#xD;
&#xD;
               -  Severe visual or hearing impairment&#xD;
&#xD;
               -  Unwillingness to comply with the protocol or procedures&#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>Hong Ma, M.D.,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>The department of Anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>June 30, 2015</last_update_submitted>
  <last_update_submitted_qc>June 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University, China</investigator_affiliation>
    <investigator_full_name>Wen-fei Tan</investigator_full_name>
    <investigator_title>Associate proffessor</investigator_title>
  </responsible_party>
  <keyword>cytokine Transversus Abdominis Plane Block</keyword>
  <!-- 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/NCT02219542
org study id: 20140804
nct id: NCT02219542
lead sponsor: 
has dmc: Yes
The investigators designed a study to determine whether with combined general-transversus
      abdominis plane block anesthesia or standard general anaesthetic would provide same level of
      cytokines in patients undergoing Laparoscopic Colonic Surgery.
The investigators designed a study to determine whether combined general-transversus
      abdominis plane block anesthesia or standard general anaesthetic would provide same level of
      cytokine in patients undergoing Laparoscopic Colonic Surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: The change of cytokine level in plasma samples
time frame: just after anesthesia induction ; at the end of the surgery; 24h after surgery
description: The blood samples were collected before induction of anesthesia and at the end of surgery.
arm group label: a standard general anesthesia
arm group type: Placebo Comparator
description: a standard general anesthesia and with transversus abdominis plane block 20 ml 0.9% sodium chloride
arm group label: transversus abdominis plane block
arm group type: Experimental
description: a standard general anesthesia with transversus abdominis plane block 20 mL 0.25% ropivacaine
intervention type: Drug
intervention name: transversus abdominis plane block
description: transversus abdominis plane block with 20 mL saline
arm group label: a standard general anesthesia
intervention type: Drug
intervention name: transversus abdominis plane block
description: transversus abdominis plane block with 20 mL 0.25% ropivacaine
arm group label: transversus abdominis plane block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hong Ma, M.D.,PhD
role: Study Chair
affiliation: The department of Anesthesiology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China Medical University, China
investigator full name: Wen-fei Tan
investigator title: Associate proffessor