<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/NCT03761576</url>
  </required_header>
  <id_info>
    <org_study_id>2018PHB191-02</org_study_id>
    <nct_id>NCT03761576</nct_id>
  </id_info>
  <brief_title>The Role of Cognitive Function and Electroencephalography on Acute and Chronic Pain After Surgery</brief_title>
  <official_title>The Role of Cognitive Function and Electroencephalography on Acute and Chronic Pain After Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yi Feng, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's Hospital</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 project will apply the methods of clinical observation experiment, (1) to collect the&#xD;
      cognitive function data preoperatively and early postoperatively, as well as the pain score&#xD;
      data at multiple time points pre- and postoperatively, and to observe the role of the degree&#xD;
      of recovery of early postoperative cognitive function on acute pain and chronic pain after&#xD;
      surgery. (2) to collect the resting-state electroencephalography (EEG) preoperatively, and to&#xD;
      assess the role of EEG index system on the prediction of the degree of recovery of early&#xD;
      postoperative cognitive function as well as the acute pain and chronic pain after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients after surgery are liable to suffer from moderate to severe acute pain and refractory&#xD;
      chronic pain, which would lead to serious somatic and psychological suffering. Its successful&#xD;
      treatment is a great challenge for pain physicians. To date, the mechanism of pain&#xD;
      chronification after surgery remains unclear. Further, it is still lack of efficient&#xD;
      preventive and therapeutic measures for this chronic pain. The project will apply the methods&#xD;
      of clinical observation and animal experiment, (1) to collect the cognitive function data&#xD;
      preoperatively and early postoperatively, as well as the pain score data at multiple time&#xD;
      points pre- and postoperatively, and to observe the role of the degree of recovery of early&#xD;
      postoperative cognitive function on acute pain and chronic pain after thoracic surgery. (2)&#xD;
      to collect the resting-state electroencephalography (EEG) preoperatively, and to assess the&#xD;
      role of EEG index system on the prediction of the degree of recovery of early postoperative&#xD;
      cognitive function as well as the acute pain and chronic pain after thoracic surgery. The&#xD;
      project will be able to determine the relationships between the degree of recovery of early&#xD;
      postoperative cognitive function, as well as preoperative resting-state EEG indices and&#xD;
      postoperative acute pain and chronic pain, and clarify the neural mechanism of acute pain and&#xD;
      chronic pain after surgery. The expected outcomes of this study can contribute to early&#xD;
      identification of the patients who are liable to develop into acute pain and chronic pain&#xD;
      after surgery, and give them reasonable intervention in time, and provide effective solutions&#xD;
      for the acute pain and chronic pain after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>acute pain</measure>
    <time_frame>the third day of the surgery</time_frame>
    <description>numerical rating scale(NRS)&gt;3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>chronic pain</measure>
    <time_frame>the second month of the surgery</time_frame>
    <description>numerical rating scale(NRS)&gt;3</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acute Pain</condition>
  <condition>Chronic Pain</condition>
  <condition>Thoracic Surgery</condition>
  <condition>Electroencephalography</condition>
  <condition>Brain Mechanism</condition>
  <eligibility>
    <study_pop>
      <textblock>
        100&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  surgery were planned to be performed under general anesthesia&#xD;
&#xD;
          -  Educational attainment beyond high school&#xD;
&#xD;
          -  Require postoperative analgesia and sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with mental illness or a family history of mental illness&#xD;
&#xD;
          -  Patients with cerebrovascular diseases or cerebrovascular accidents&#xD;
&#xD;
          -  Previous head trauma history or craniotomy&#xD;
&#xD;
          -  Using central analgesics, opioids addiction&#xD;
&#xD;
          -  With a history of alcoholism&#xD;
&#xD;
          -  do not understand the numerical rating scale(NRS) score and can not use&#xD;
             patient-controlled analgesia(PCA）&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi Feng, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>October 15, 2022</last_update_submitted>
  <last_update_submitted_qc>October 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>Yi Feng, MD</investigator_full_name>
    <investigator_title>director of department of anesthesiology and painmanagement</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Acute 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/NCT03761576
org study id: 2018PHB191-02
nct id: NCT03761576
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The project will apply the methods of clinical observation experiment, (1) to collect the
      cognitive function data preoperatively and early postoperatively, as well as the pain score
      data at multiple time points pre- and postoperatively, and to observe the role of the degree
      of recovery of early postoperative cognitive function on acute pain and chronic pain after
      surgery. (2) to collect the resting-state electroencephalography (EEG) preoperatively, and to
      assess the role of EEG index system on the prediction of the degree of recovery of early
      postoperative cognitive function as well as the acute pain and chronic pain after surgery.
Patients after surgery are liable to suffer from moderate to severe acute pain and refractory
      chronic pain, which would lead to serious somatic and psychological suffering. Its successful
      treatment is a great challenge for pain physicians. To date, the mechanism of pain
      chronification after surgery remains unclear. Further, it is still lack of efficient
      preventive and therapeutic measures for this chronic pain. The project will apply the methods
      of clinical observation and animal experiment, (1) to collect the cognitive function data
      preoperatively and early postoperatively, as well as the pain score data at multiple time
      points pre- and postoperatively, and to observe the role of the degree of recovery of early
      postoperative cognitive function on acute pain and chronic pain after thoracic surgery. (2)
      to collect the resting-state electroencephalography (EEG) preoperatively, and to assess the
      role of EEG index system on the prediction of the degree of recovery of early postoperative
      cognitive function as well as the acute pain and chronic pain after thoracic surgery. The
      project will be able to determine the relationships between the degree of recovery of early
      postoperative cognitive function, as well as preoperative resting-state EEG indices and
      postoperative acute pain and chronic pain, and clarify the neural mechanism of acute pain and
      chronic pain after surgery. The expected outcomes of this study can contribute to early
      identification of the patients who are liable to develop into acute pain and chronic pain
      after surgery, and give them reasonable intervention in time, and provide effective solutions
      for the acute pain and chronic pain after surgery.
observational model: Case-Only
time perspective: Prospective
measure: acute pain
time frame: the third day of the surgery
description: numerical rating scale(NRS)>3
measure: chronic pain
time frame: the second month of the surgery
description: numerical rating scale(NRS)>3
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yi Feng, MD
role: Study Chair
affiliation: Peking University People's Hospital
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Yi Feng, MD
investigator title: director of department of anesthesiology and painmanagement
mesh term: Chronic Pain
mesh term: Acute Pain