<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/NCT03021447</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-OBS-16-48</org_study_id>
    <nct_id>NCT03021447</nct_id>
  </id_info>
  <brief_title>Prediction of Postoperative Pain by Injection Pain of Propofol</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative pain is a significant postoperative problem and it could be persistent if&#xD;
      proper management is not provided. However, each patient shows different intensity of pain&#xD;
      and different sensitivity to analgesics even if they underwent same procedures. Therefore, it&#xD;
      would be useful to find the way to predict the postoperative pain sensitivity.&#xD;
&#xD;
      Propofol, a popular anesthetic agent, induces pain during injection, which can not completely&#xD;
      prevented by opioid or lidocaine in some patients. This is considered to be related to&#xD;
      patient's pain sensitivity and it might be associated with postoperative pain sensitivity.&#xD;
&#xD;
      Therefore, the relation of propofol injection pain and postoperative pain intensity will be&#xD;
      explored.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 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>postoperative pain intensity_1</measure>
    <time_frame>10 min after postanesthesia care unit admission</time_frame>
    <description>Postoperative pain will be evaluated with verbal numeric scale (0-10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain intensity_2</measure>
    <time_frame>20 min after postanesthesia care unit admission</time_frame>
    <description>Postoperative pain will be evaluated with verbal numeric scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative pain intensity_3</measure>
    <time_frame>30 min after postanesthesia care unit admission</time_frame>
    <description>Postoperative pain will be evaluated with verbal numeric scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative pain intensity_4</measure>
    <time_frame>4 hours after operation</time_frame>
    <description>Postoperative pain will be evaluated with verbal numeric scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative pain intensity_8</measure>
    <time_frame>8 hours after operation</time_frame>
    <description>Postoperative pain will be evaluated with verbal numeric scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative pain intensity_12</measure>
    <time_frame>12 hours after operation</time_frame>
    <description>Postoperative pain will be evaluated with verbal numeric scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative pain intensity_24</measure>
    <time_frame>24 hours after operation</time_frame>
    <description>Postoperative pain will be evaluated with verbal numeric scale (0-10)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Cholecystitis, Acute</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for laparoscopic cholecystectomy will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  America Society of Anesthesiologists class I-II&#xD;
&#xD;
          -  Laparoscopic cholecystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Illiteracy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Go Un Roh</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Cholecystitis, Acute</mesh_term>
  </condition_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/NCT03021447
org study id: AJIRB-MED-OBS-16-48
nct id: NCT03021447
lead sponsor: 
has dmc: No
Postoperative pain is a significant postoperative problem and it could be persistent if
      proper management is not provided. However, each patient shows different intensity of pain
      and different sensitivity to analgesics even if they underwent same procedures. Therefore, it
      would be useful to find the way to predict the postoperative pain sensitivity.

      Propofol, a popular anesthetic agent, induces pain during injection, which can not completely
      prevented by opioid or lidocaine in some patients. This is considered to be related to
      patient's pain sensitivity and it might be associated with postoperative pain sensitivity.

      Therefore, the relation of propofol injection pain and postoperative pain intensity will be
      explored.
observational model: Cohort
time perspective: Prospective
measure: postoperative pain intensity_1
time frame: 10 min after postanesthesia care unit admission
description: Postoperative pain will be evaluated with verbal numeric scale (0-10)
measure: postoperative pain intensity_2
time frame: 20 min after postanesthesia care unit admission
description: Postoperative pain will be evaluated with verbal numeric scale (0-10)
measure: postoperative pain intensity_3
time frame: 30 min after postanesthesia care unit admission
description: Postoperative pain will be evaluated with verbal numeric scale (0-10)
measure: postoperative pain intensity_4
time frame: 4 hours after operation
description: Postoperative pain will be evaluated with verbal numeric scale (0-10)
measure: postoperative pain intensity_8
time frame: 8 hours after operation
description: Postoperative pain will be evaluated with verbal numeric scale (0-10)
measure: postoperative pain intensity_12
time frame: 12 hours after operation
description: Postoperative pain will be evaluated with verbal numeric scale (0-10)
measure: postoperative pain intensity_24
time frame: 24 hours after operation
description: Postoperative pain will be evaluated with verbal numeric scale (0-10)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 60 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Go Un Roh
investigator title: principal investigator
mesh term: Cholecystitis
mesh term: Cholecystitis, Acute
sharing ipd: No