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/NCT06011044</url>
    </required_header>
    <id_info>
      <org_study_id>Bwen</org_study_id>
      <nct_id>NCT06011044</nct_id>
    </id_info>
    <brief_title>Intercostal Nerve Block With Local Anesthesia Administered Via Incision-specific Multi-site Injection for Thoracic Surgery</brief_title>
    <official_title>Intercostal Nerve Block With Local Anesthesia Administered Via Incision-specific Multi-site Injection for Thoracic Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bixin Wen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China-Japan Friendship 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 clinical trial is to test analgesic effect of intercostal nerve block in&#xD;
        different range. The main question it aims to answer are:&#xD;
  &#xD;
        question 1: whther incision-specific multi-site injection (ISMSI, from the 3rd to 8th&#xD;
        intercostal nerve) can improve the analgesic benefits .&#xD;
  &#xD;
        The participants will be divided into three groups to compare the analgesic effects of&#xD;
        different intercostal nerve blocks&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postoperative pain after thoracic surgery is usually severe, and potentially leads to worse&#xD;
        outcomes. It is well known that the use of intercostal nerve block (ICNB) analgesia with&#xD;
        local anesthesia is common in thoracic surgery. Compared with the traditional standard of&#xD;
        epidural analgesia, it has the advantages of less effect on respiratory or circulation system&#xD;
        and less postoperative complications such as hypotension and hematoma. However, the details&#xD;
        of ICNB form different hospital are in different ways. And it is unclear how many intercostal&#xD;
        nerves should be blocked. And it is unknown which area should be payed more attention either,&#xD;
        like the incision area or the chest tube port. It is hypothesized that the incision-specific&#xD;
        multi-site injection (ISMSI, from the 3rd to 8th intercostal nerve) can improve the analgesic&#xD;
        benefits due to cover area of both incision and chest tube port. To test this hypothesis, the&#xD;
        investigators did this study to evaluate the analgesic effect of different ICNB methods.&#xD;
  &#xD;
        The participants will be divided into three groups. A(incision-specific multi-site injection,&#xD;
        received intraoperative 3-8 intercostal nerve block ) B(single injection, received&#xD;
        intraoperative 3-5 intercostal nerve block ) and C(received no intercostal nerve block). Then&#xD;
        compare the analgesic effects of the three groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 19, 2023</start_date>
    <completion_date type="Anticipated">October 19, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 19, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Visual Analogue Scale (VAS)</measure>
      <time_frame>first month after surgery</time_frame>
      <description>We will use VAS score to assess the analgesic effects . The Visual Analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain since the 1920s. It consists of a line usually 100mm in length, with anchor descriptors such as &quot;no pain&quot; and &quot;worst pain imaginable&quot;, The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Visual Analogue Scale (VAS)</measure>
      <time_frame>third month after surgery</time_frame>
      <description>We will use VAS score to assess the analgesic effects . The Visual Analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain since the 1920s. It consists of a line usually 100mm in length, with anchor descriptors such as &quot;no pain&quot; and &quot;worst pain imaginable&quot;, The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Intercostal Nerve Block</condition>
    <arm_group>
      <arm_group_label>Intercostal nerve block with ropivacaine（0.5%）</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group of patients will be further divided into 2 groups. Group A (incision-specific multi-site injection) received intraoperative 3-8 intercostal nerve block with 0.5% ropivacaine. Group B (single injection) received intraoperative 3-5 intercostal nerve block with 0.5% .After completing lung surgery, fully exposing the lateral and posterior chest wall. From the inside view of the chest cavity, the intercostal nerve enters the correlated intercostal space between the posterior intercostal membrane and the parietal pleura. The needle of the 1ml syringe was held with a thoracoscopic ovale forceps and the target intercostal nerves were confirmed. It is only necessary to puncture the parietal pleura at the side of the intercostal nerve to perform the block. Inject ropivacaine(1ml, 0.5%) into the target nerve. At the same time, we recorded patients' mental status and vital signs to avoid systemic toxicity.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>no intercostal nerve block.</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group of patients will not receive intraoperative intercostal nerve block with 0.5% ropivacaine. After completing lung surgery, fully exposing the lateral and posterior chest wall. From the inside view of the chest cavity, the intercostal nerve enters the correlated intercostal space between the posterior intercostal membrane and the parietal pleura. The needle of the 1ml syringe was held with a thoracoscopic ovale forceps and the target intercostal nerves were confirmed. Inject physiologic saline(1ml) into the target nerve.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Intercostal Nerve Block</intervention_name>
      <description>The intercostal nerve block test is a medical intervention that involves the administration of a local anesthetic to the intercostal nerves, which are located between the ribs. The intervention involves injecting a small amount of anesthetic solution near the targeted intercostal nerves, which temporarily numbs the area and provides potential pain relief. The intercostal nerve block test is considered a diagnostic tool to help guide further treatment decisions for conditions such as intercostal neuralgia, rib fractures, or postoperative pain. It is generally a safe and well-tolerated procedure, often performed under local anesthesia or with the assistance of image guidance to ensure accurate needle placement. Following the test, the patient's response is evaluated, and if pain relief is achieved, it may indicate that intercostal nerve block injections could be an appropriate treatment option.</description>
      <arm_group_label>Intercostal nerve block with ropivacaine（0.5%）</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients undergoing surgery for small pulmonary nodules in the Department of Thoracic&#xD;
               Surgery, China-Japan Friendship Hospital in Beijing&#xD;
  &#xD;
            2. Age≥ 18 years old&#xD;
  &#xD;
            3. Lung small nodules with a diameter of ≤ 2cm, pure ground-glass/mixed/solid nodules&#xD;
  &#xD;
            4. Permanent residents can be followed up for a long time&#xD;
  &#xD;
            5. Sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Refusal to sign informed consent&#xD;
  &#xD;
            2. Damaged heart, lung, liver and kidney function&#xD;
  &#xD;
            3. Contraindications to surgery, such as inability to tolerate anesthesia, distant&#xD;
               metastasis, bleeding tendency, etc c(4) Combined with severe emphysema, tuberculosis,&#xD;
               pneumothorax, pleural effusion (5) Patients have other conditions that are not&#xD;
               suitable for interventional surgery, such as pregnancy, lactation, long-term use of&#xD;
               immunosuppressants, and serious infections&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>QianLI MA, doctor's degree</last_name>
      <phone>86+13681332289</phone>
      <email>mars_qlma@163.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
      <investigator_full_name>Bixin Wen</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06011044
  org study id: Bwen
  nct id: NCT06011044
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test analgesic effect of intercostal nerve block in
        different range. The main question it aims to answer are:
  
        question 1: whther incision-specific multi-site injection (ISMSI, from the 3rd to 8th
        intercostal nerve) can improve the analgesic benefits .
  
        The participants will be divided into three groups to compare the analgesic effects of
        different intercostal nerve blocks
  Postoperative pain after thoracic surgery is usually severe, and potentially leads to worse
        outcomes. It is well known that the use of intercostal nerve block (ICNB) analgesia with
        local anesthesia is common in thoracic surgery. Compared with the traditional standard of
        epidural analgesia, it has the advantages of less effect on respiratory or circulation system
        and less postoperative complications such as hypotension and hematoma. However, the details
        of ICNB form different hospital are in different ways. And it is unclear how many intercostal
        nerves should be blocked. And it is unknown which area should be payed more attention either,
        like the incision area or the chest tube port. It is hypothesized that the incision-specific
        multi-site injection (ISMSI, from the 3rd to 8th intercostal nerve) can improve the analgesic
        benefits due to cover area of both incision and chest tube port. To test this hypothesis, the
        investigators did this study to evaluate the analgesic effect of different ICNB methods.
  
        The participants will be divided into three groups. A(incision-specific multi-site injection,
        received intraoperative 3-8 intercostal nerve block ) B(single injection, received
        intraoperative 3-5 intercostal nerve block ) and C(received no intercostal nerve block). Then
        compare the analgesic effects of the three groups.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: The Visual Analogue Scale (VAS)
  time frame: first month after surgery
  description: We will use VAS score to assess the analgesic effects . The Visual Analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain since the 1920s. It consists of a line usually 100mm in length, with anchor descriptors such as "no pain" and "worst pain imaginable", The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm.
  measure: The Visual Analogue Scale (VAS)
  time frame: third month after surgery
  description: We will use VAS score to assess the analgesic effects . The Visual Analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain since the 1920s. It consists of a line usually 100mm in length, with anchor descriptors such as "no pain" and "worst pain imaginable", The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm.
  arm group label: Intercostal nerve block with ropivacaine（0.5%）
  arm group type: Experimental
  description: This group of patients will be further divided into 2 groups. Group A (incision-specific multi-site injection) received intraoperative 3-8 intercostal nerve block with 0.5% ropivacaine. Group B (single injection) received intraoperative 3-5 intercostal nerve block with 0.5% .After completing lung surgery, fully exposing the lateral and posterior chest wall. From the inside view of the chest cavity, the intercostal nerve enters the correlated intercostal space between the posterior intercostal membrane and the parietal pleura. The needle of the 1ml syringe was held with a thoracoscopic ovale forceps and the target intercostal nerves were confirmed. It is only necessary to puncture the parietal pleura at the side of the intercostal nerve to perform the block. Inject ropivacaine(1ml, 0.5%) into the target nerve. At the same time, we recorded patients' mental status and vital signs to avoid systemic toxicity.
  arm group label: no intercostal nerve block.
  arm group type: No Intervention
  description: This group of patients will not receive intraoperative intercostal nerve block with 0.5% ropivacaine. After completing lung surgery, fully exposing the lateral and posterior chest wall. From the inside view of the chest cavity, the intercostal nerve enters the correlated intercostal space between the posterior intercostal membrane and the parietal pleura. The needle of the 1ml syringe was held with a thoracoscopic ovale forceps and the target intercostal nerves were confirmed. Inject physiologic saline(1ml) into the target nerve.
  intervention type: Procedure
  intervention name: Intercostal Nerve Block
  description: The intercostal nerve block test is a medical intervention that involves the administration of a local anesthetic to the intercostal nerves, which are located between the ribs. The intervention involves injecting a small amount of anesthetic solution near the targeted intercostal nerves, which temporarily numbs the area and provides potential pain relief. The intercostal nerve block test is considered a diagnostic tool to help guide further treatment decisions for conditions such as intercostal neuralgia, rib fractures, or postoperative pain. It is generally a safe and well-tolerated procedure, often performed under local anesthesia or with the assistance of image guidance to ensure accurate needle placement. Following the test, the patient's response is evaluated, and if pain relief is achieved, it may indicate that intercostal nerve block injections could be an appropriate treatment option.
  arm group label: Intercostal nerve block with ropivacaine（0.5%）
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: QianLI MA, doctor's degree
  phone: 86+13681332289
  email: mars_qlma@163.com
  responsible party type: Sponsor-Investigator
  investigator affiliation: China-Japan Friendship Hospital
  investigator full name: Bixin Wen
  investigator title: Principal Investigator
  sharing ipd: Undecided