<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/NCT03009955</url>
  </required_header>
  <id_info>
    <org_study_id>Postoperative pain</org_study_id>
    <nct_id>NCT03009955</nct_id>
  </id_info>
  <brief_title>Comparison of Postoperative Pain Between Patients Received Primary and Repeated Caesarean Section</brief_title>
  <official_title>Comparison of Postoperative Pain Between Patients Received Primary and Repeated Caesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinqiao Hospital of Chongqing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinqiao Hospital of Chongqing</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To everyone knows, more and more patients received repeated caesarean section in China.&#xD;
      However, at present it is not known what is it like about their postoperative pain intensity,&#xD;
      and is it different from those patients who received primary caesarean section. Thus through&#xD;
      postoperative follow-up, the current study aimed to investigate and compare the postoperative&#xD;
      pain between patients received primary and repeated caesarean section.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to whether or not to receive repeated caesarean patients were grouped into group P&#xD;
      or group R. For all maternal,standardized epidural anesthesia and caesarean section were&#xD;
      performed. Then the pain VAS scores and Ramsay scores at 4h, 8h, 12h, 24h and 48h after the&#xD;
      surgery were recorded. And sleep quality at 1 day and 2 day after the surgery were recorded.&#xD;
      In addition, pain situation at 1 week and 4 weeks after the surgery was followed up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain VAS at 4, 8, 12, 24 and 48 hours after the surgery</measure>
    <time_frame>At 4, 8, 12, 24 and 48 hours after the surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity at 3 to 7 days after the surgery</measure>
    <time_frame>At 3 to 7 days after the surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity at 4 weeks after the surgery</measure>
    <time_frame>At 4 weeks after the surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">168</enrollment>
  <condition>Caesarean Section</condition>
  <arm_group>
    <arm_group_label>Group P</arm_group_label>
    <description>patients who received primary caesarean section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group R</arm_group_label>
    <description>patients who received repeated caesarean section</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who receiving primary and repeated caesarean section.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  single birth&#xD;
&#xD;
          -  full-term pregnancy&#xD;
&#xD;
          -  in accordance with cesarean section indications&#xD;
&#xD;
          -  transverse incision of lower uterine segment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of dementia, psychiatric illness or any diseases of central nervous system&#xD;
&#xD;
          -  accompanying liver or kidney function deficiency&#xD;
&#xD;
          -  alcoholism and drug dependence&#xD;
&#xD;
          -  patients previously included in this study or currently included in the other clinical&#xD;
             study&#xD;
&#xD;
          -  patients who have second surgery during the study period&#xD;
&#xD;
          -  difficult to follow up or patients with poor compliance&#xD;
&#xD;
          -  history of chronic pain&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Li, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xinqiao Hospital, Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>July 3, 2017</last_update_submitted>
  <last_update_submitted_qc>July 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinqiao Hospital of Chongqing</investigator_affiliation>
    <investigator_full_name>Hong Li</investigator_full_name>
    <investigator_title>Director, Department of Anesthesiology</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>Undecided</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/NCT03009955
org study id: Postoperative pain
nct id: NCT03009955
lead sponsor: 
has dmc: Yes
To everyone knows, more and more patients received repeated caesarean section in China.
      However, at present it is not known what is it like about their postoperative pain intensity,
      and is it different from those patients who received primary caesarean section. Thus through
      postoperative follow-up, the current study aimed to investigate and compare the postoperative
      pain between patients received primary and repeated caesarean section.
According to whether or not to receive repeated caesarean patients were grouped into group P
      or group R. For all maternal,standardized epidural anesthesia and caesarean section were
      performed. Then the pain VAS scores and Ramsay scores at 4h, 8h, 12h, 24h and 48h after the
      surgery were recorded. And sleep quality at 1 day and 2 day after the surgery were recorded.
      In addition, pain situation at 1 week and 4 weeks after the surgery was followed up.
observational model: Cohort
time perspective: Prospective
measure: Pain VAS at 4, 8, 12, 24 and 48 hours after the surgery
time frame: At 4, 8, 12, 24 and 48 hours after the surgery
measure: Pain intensity at 3 to 7 days after the surgery
time frame: At 3 to 7 days after the surgery
measure: Pain intensity at 4 weeks after the surgery
time frame: At 4 weeks after the surgery
arm group label: Group P
description: patients who received primary caesarean section
arm group label: Group R
description: patients who received repeated caesarean section
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Hong Li, M.D.
role: Principal Investigator
affiliation: Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinqiao Hospital of Chongqing
investigator full name: Hong Li
investigator title: Director, Department of Anesthesiology
mesh term: Pain, Postoperative
sharing ipd: Undecided