xml: <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/NCT06002724</url>
    </required_header>
    <id_info>
      <org_study_id>taoliqin0730</org_study_id>
      <nct_id>NCT06002724</nct_id>
    </id_info>
    <brief_title>Feasibility Study of Peripheral Venous Cannulation Pain in Predicting Acute Pain After Total Knee Arthroplasty</brief_title>
    <official_title>Feasibility Study of Peripheral Venous Cannulation Pain in Predicting Acute Pain After</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi 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 goal of this prospective observational study is to explore the feasibility of&#xD;
        preoperative peripheral venous cannulation pain score in predicting acute pain after total&#xD;
        knee arthroplasty, including resting pain and movement-evoked pain.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>postoperative resting pain and movement-evoked pain</measure>
      <time_frame>one hour、the first day and the second day after operation</time_frame>
      <description>visual analogue scale（VAS) of one hour、the first day and the second day after operation</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Venous Cannulation Pain</condition>
    <condition>Total Knee Arthroplasty</condition>
    <condition>Movement-evoked Pain</condition>
    <condition>Acute Pain</condition>
    <arm_group>
      <arm_group_label>0</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing unilateral total knee arthroplasty for the first time under general&#xD;
          anesthesia combined with nerve block&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients undergoing the first unilateral total knee arthroplasty surgery under general&#xD;
               anesthesia combined with nerve block ;&#xD;
  &#xD;
            2. Age : 18 years old ≤ age ≤ 80 years old ;&#xD;
  &#xD;
            3. ASA grade I-II ;&#xD;
  &#xD;
            4. Informed consent was signed by patients or immediate family members before operation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. There are known pain abnormalities, mental disorders, cognitive dysfunction ;&#xD;
  &#xD;
            2. patients with long-term use of opioids and a history of drug dependence ;&#xD;
  &#xD;
            3. patients with alcohol dependence ;&#xD;
  &#xD;
            4. the patient refused to use the analgesic pump ;&#xD;
  &#xD;
            5. Difficult to understand the VAS score ;&#xD;
  &#xD;
            6. body mass index ≥ 40 ;&#xD;
  &#xD;
            7. hand nerve abnormalities, hand loss ;&#xD;
  &#xD;
            8. plan postoperative ICU patients ;&#xD;
  &#xD;
            9. In other cases, the researchers believe that is not suitable for this researcher.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Liqin Tao</last_name>
      <phone>18020264650</phone>
      <email>1349468702@qq.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002724
  org study id: taoliqin0730
  nct id: NCT06002724
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective observational study is to explore the feasibility of
        preoperative peripheral venous cannulation pain score in predicting acute pain after total
        knee arthroplasty, including resting pain and movement-evoked pain.
  observational model: Other
  time perspective: Prospective
  measure: postoperative resting pain and movement-evoked pain
  time frame: one hour、the first day and the second day after operation
  description: visual analogue scale（VAS) of one hour、the first day and the second day after operation
  arm group label: 0
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Liqin Tao
  phone: 18020264650
  email: 1349468702@qq.com
  responsible party type: Sponsor
  mesh term: Acute Pain
  sharing ipd: No