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/NCT06006026</url>
    </required_header>
    <id_info>
      <org_study_id>20201180HX</org_study_id>
      <nct_id>NCT06006026</nct_id>
    </id_info>
    <brief_title>The Safety of Ropivacaine TAP Block Combined With Intravenous Lidocaine in Patients Undergoing Colorectal Cancer Surgery</brief_title>
    <official_title>The Safety of Ropivacaine Transversus Abdominis Plane Block Combined With Intravenous Lidocaine in Patients Undergoing Colorectal Cancer Surgery: a Single Center, Open Label Dose Escalation Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>West China Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>West China Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Many studies have confirmed the analgesic effect of intravenous infusion of lidocaine in&#xD;
        abdominal surgery. Transversus abdominis plane (TAP) block is also often recommended for&#xD;
        abdominal surgery. Ropivacaine TAP block and intravenous lidocaine infusion are important&#xD;
        components of multimodal analgesia for colorectal surgery. However, both of them are the&#xD;
        local anesthetics and the safety of combination is unknown, so we design the study to explore&#xD;
        the safety of the synergistic application of ropivacaine TAP block and intravenous lidocaine&#xD;
        infusion in patients undergoing colorectal surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>Interventional Study Model: Sequential Assignment According to the principle of &quot;the 3+3 design&quot;, 3 dose groups with 3 patients in each dose group will be set up. If no dose limited toxicity (DLT) is observed in three groups, a total of 9 patients will be included. If DLT is present in one dose group during dose escalation, 3 cases are amplified in this dose group; if no DLT is observed in 3 cases of amplification, proceed to the next dose group, and so on, up to 18 patients. DLT is defined as local anesthetic systemic toxicity. If blood samples cannot be obtained for any reasons, new patients will be recruited until there are at least 3 patients in each group with blood samples at every time point .</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The safety profile of combining ropivacaine and lidocaine</measure>
      <time_frame>From administration of ropivacaine or lidocaine to postoperative 24 hours</time_frame>
      <description>To observe signs of LAST, such as dizziness, light-headedness, metallic taste, peri-oral numbness, seizure activity or tinnitus, new-onset ECG irregularities, or intraoperative spike wave of EEG, et al.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The plasma concentration of ropivacaine</measure>
      <time_frame>From 10 min to 24h after the completion of bilateral TAP block</time_frame>
      <description>Blood samples will be drawn at 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 12h and 24h after the completion of bilateral TAP block to measure the plasma ropivacaine concentration. All data will be tested for normality, then we will show the central tendency of the blood concentration of ropivacaine for all patients at each time point by means (standard deviation) or median (interquartile interval), the peak time and peak concentration of the blood concentration of ropivacaine. We will also provide trends in the blood concentration of ropivacaine for each patient, and the concentration trend of blood drug concentration in each group of patients according to dose grouping.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The plasma concentration of lidocaine</measure>
      <time_frame>From 10 min to 24h after the initiation of IV lidocaine.</time_frame>
      <description>Blood samples will be drawn at 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 12h and 24h after the initiation of IV lidocaine to measure the plasma lidocaine concentration. All data will be tested for normality, then we will show the central tendency of the blood concentration of lidocaine for all patients at each time point by means (standard deviation) or median (interquartile interval), and the peak time and peak concentration of the blood concentration of lidocaine. We will also provide trends in the blood concentration of lidocaine for each patient. and the concentration trend of blood drug concentration in each group of patients according to dose grouping.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">9</enrollment>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>ropivacaine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive a TAP block using 1.5 mg/kg, 2.0 mg/kg or 2.5 mg/kg of ropivacaine. If there is no LAST (local anesthetic systemic toxicity) in the three subjects of 1.5 mg/kg group, the next three patients will receive 2.0 mg/kg of ropivacaine. Another three patients will receive 2.5 mg/kg of ropivacaine if there is no LAST in the three subjects of 2.0 mg/kg group. All subjects will be administered an i.v. bolus of lidocaine 2.0 mg/kg (given as an infusion for 10 min) after anaesthesia induction, then continuous infusion at 2 mg/kg/h until the end of surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ropivacaine Hydrochloride 10 MG/ML [Naropin]</intervention_name>
      <description>According to the specified dosage, dilute 1% ropivacaine to 0.2% and inject 1/2 of the total amount on each side.</description>
      <arm_group_label>ropivacaine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged between 18 and 65 years;&#xD;
  &#xD;
            2. Patients who plan to undergo open/laparoscopic colorectal cancer resection surgery&#xD;
               under general anesthesia;&#xD;
  &#xD;
            3. American society of Anesthesiologists (ASA) physical status classification system&#xD;
               I~II;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Weight less than 40kg or more than 100kg;&#xD;
  &#xD;
            2. Defects in the cardiac conduction system (II or III degree atrioventricular block) or&#xD;
               cardiac dysfunction (LVEF&lt;50%);&#xD;
  &#xD;
            3. Severe liver dysfunction (ALT, AST, bilirubin 2.5 times higher than normal), renal&#xD;
               dysfunction (creatinine clearance rate&lt;60ml/min);&#xD;
  &#xD;
            4. Allergies to experimental drugs;&#xD;
  &#xD;
            5. Patients who are unable to communicate;&#xD;
  &#xD;
            6. Participating in other clinical researchers.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Weiming Li, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>West China Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chunling Jiang, PhD</last_name>
      <phone>18980601096</phone>
      <email>jiangchunling@scu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Li Zhou, PhD</last_name>
      <phone>+8602885423593</phone>
      <email>714549399@qq.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>West China Hospital</investigator_affiliation>
      <investigator_full_name>Chunling Jiang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ropivacaine</mesh_term>
    </intervention_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/NCT06006026
  org study id: 20201180HX
  nct id: NCT06006026
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Many studies have confirmed the analgesic effect of intravenous infusion of lidocaine in
        abdominal surgery. Transversus abdominis plane (TAP) block is also often recommended for
        abdominal surgery. Ropivacaine TAP block and intravenous lidocaine infusion are important
        components of multimodal analgesia for colorectal surgery. However, both of them are the
        local anesthetics and the safety of combination is unknown, so we design the study to explore
        the safety of the synergistic application of ropivacaine TAP block and intravenous lidocaine
        infusion in patients undergoing colorectal surgery.
  allocation: N/A
  intervention model: Sequential Assignment
  intervention model description: Interventional Study Model: Sequential Assignment According to the principle of "the 3+3 design", 3 dose groups with 3 patients in each dose group will be set up. If no dose limited toxicity (DLT) is observed in three groups, a total of 9 patients will be included. If DLT is present in one dose group during dose escalation, 3 cases are amplified in this dose group; if no DLT is observed in 3 cases of amplification, proceed to the next dose group, and so on, up to 18 patients. DLT is defined as local anesthetic systemic toxicity. If blood samples cannot be obtained for any reasons, new patients will be recruited until there are at least 3 patients in each group with blood samples at every time point .
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The safety profile of combining ropivacaine and lidocaine
  time frame: From administration of ropivacaine or lidocaine to postoperative 24 hours
  description: To observe signs of LAST, such as dizziness, light-headedness, metallic taste, peri-oral numbness, seizure activity or tinnitus, new-onset ECG irregularities, or intraoperative spike wave of EEG, et al.
  measure: The plasma concentration of ropivacaine
  time frame: From 10 min to 24h after the completion of bilateral TAP block
  description: Blood samples will be drawn at 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 12h and 24h after the completion of bilateral TAP block to measure the plasma ropivacaine concentration. All data will be tested for normality, then we will show the central tendency of the blood concentration of ropivacaine for all patients at each time point by means (standard deviation) or median (interquartile interval), the peak time and peak concentration of the blood concentration of ropivacaine. We will also provide trends in the blood concentration of ropivacaine for each patient, and the concentration trend of blood drug concentration in each group of patients according to dose grouping.
  measure: The plasma concentration of lidocaine
  time frame: From 10 min to 24h after the initiation of IV lidocaine.
  description: Blood samples will be drawn at 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 12h and 24h after the initiation of IV lidocaine to measure the plasma lidocaine concentration. All data will be tested for normality, then we will show the central tendency of the blood concentration of lidocaine for all patients at each time point by means (standard deviation) or median (interquartile interval), and the peak time and peak concentration of the blood concentration of lidocaine. We will also provide trends in the blood concentration of lidocaine for each patient. and the concentration trend of blood drug concentration in each group of patients according to dose grouping.
  arm group label: ropivacaine
  arm group type: Experimental
  description: Patients will receive a TAP block using 1.5 mg/kg, 2.0 mg/kg or 2.5 mg/kg of ropivacaine. If there is no LAST (local anesthetic systemic toxicity) in the three subjects of 1.5 mg/kg group, the next three patients will receive 2.0 mg/kg of ropivacaine. Another three patients will receive 2.5 mg/kg of ropivacaine if there is no LAST in the three subjects of 2.0 mg/kg group. All subjects will be administered an i.v. bolus of lidocaine 2.0 mg/kg (given as an infusion for 10 min) after anaesthesia induction, then continuous infusion at 2 mg/kg/h until the end of surgery.
  intervention type: Drug
  intervention name: Ropivacaine Hydrochloride 10 MG/ML [Naropin]
  description: According to the specified dosage, dilute 1% ropivacaine to 0.2% and inject 1/2 of the total amount on each side.
  arm group label: ropivacaine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Weiming Li, PhD
  role: Principal Investigator
  affiliation: West China Hospital
  last name: Chunling Jiang, PhD
  phone: 18980601096
  email: jiangchunling@scu.edu.cn
  last name: Li Zhou, PhD
  phone: +8602885423593
  email: 714549399@qq.com
  responsible party type: Principal Investigator
  investigator affiliation: West China Hospital
  investigator full name: Chunling Jiang
  investigator title: Professor
  mesh term: Colorectal Neoplasms
  mesh term: Ropivacaine
  sharing ipd: No