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/NCT05990257</url>
    </required_header>
    <id_info>
      <org_study_id>CMRA123</org_study_id>
      <nct_id>NCT05990257</nct_id>
    </id_info>
    <brief_title>CMRA for US-guided-MWA of Liver Tumors</brief_title>
    <official_title>Combined Multiple Regional Anesthesia for Microwave Ablation of Liver Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lu Wang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sichuan Cancer Hospital and Research Institute</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>
        Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These&#xD;
        patients were allocated into three groups based on tumor size and number: A, B, and C. Prior&#xD;
        to the ablation procedure, Group A patients received a combination of hepatic hilar block&#xD;
        (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group&#xD;
        B were administered HHB in conjunction with LA, while those in Group C received TAPB and LA.&#xD;
        Evaluative parameters included the Numerical Rating Scale (NRS) scores, consumption of&#xD;
        morphine, incidence of complications, and factors influencing perioperative pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These&#xD;
        patients were allocated into three groups based on tumor size and number: A, B, and C. Prior&#xD;
        to the ablation procedure, Group A patients received a combination of hepatic hilar block&#xD;
        (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group&#xD;
        B were administered HHB in conjunction with LA, while those in Group C received TAPB and&#xD;
        LA.Pain levels were routinely assessed through the Numerical Rating Scale (NRS), with scores&#xD;
        being recorded by the attending nurse every 15 minutes. The frequency of these assessments&#xD;
        would be increased if the patient reported discomfort or if there were changes observed in&#xD;
        vital signs. If a patient reported a pain level of ≥4 on the NRS scale, an intravenous dose&#xD;
        of 10mg morphine was administered, provided that cardiopulmonary safety could be assured. The&#xD;
        determination of cardiopulmonary safety was made by the interventional radiologist (M. L.&#xD;
        with 20 years of experience). Following the ablation procedure, all patients were monitored&#xD;
        for a period of 36 hours. During this period, several parameters were recorded at the time of&#xD;
        the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure. These parameters&#xD;
        included the NRS score, vital signs, any need for morphine, and the occurrence of any adverse&#xD;
        events.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2018</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>pain control</measure>
      <time_frame>at the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure</time_frame>
      <description>NRS score was used to evaluate pain control</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">122</enrollment>
    <condition>Regional Anesthesia</condition>
    <condition>Pain Control</condition>
    <condition>Microwave Ablation</condition>
    <condition>Liver Tumors</condition>
    <arm_group>
      <arm_group_label>HHB+TAPB+and LA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group A: patients who received a HHB, TAPB, and LA</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HHB+LA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group B: patients who received HHB and LA</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TAPB+LA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group C: patients who received TAPB and LA</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>HHB+TAPB+and LA</intervention_name>
      <description>Hepatic Hilar Block (HHB), Transversus Abdominis Plane Block (TAPB), and Local Anesthesia (LA)</description>
      <arm_group_label>HHB+TAPB+and LA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>HHB+LA</intervention_name>
      <description>Hepatic Hilar Block (HHB) and Local Anesthesia (LA)</description>
      <arm_group_label>HHB+LA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>TAPB+LA</intervention_name>
      <description>Transversus Abdominis Plane Block (TAPB) and Local Anesthesia (LA)</description>
      <arm_group_label>TAPB+LA</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Primary hepatic carcinoma was considered if characterized by a solitary tumor (≤5cm in&#xD;
          maximum diameter) or by the presence of multiple tumors (2-3 in number, each ≤3cm in&#xD;
          maximum diameter). Importantly, these tumors were required to be devoid of vascular&#xD;
          invasion, biliary intrusion, contiguous organ invasion, or any evidence of distant&#xD;
          metastasis.&#xD;
  &#xD;
          Another group included in the study were patients with hepatic metastases, limited to no&#xD;
          more than 5 tumors each measuring ≤3cm in maximum diameter.&#xD;
  &#xD;
          Furthermore, patients with hepatic hemangioma were also considered for inclusion. Specific&#xD;
          criteria applied in these cases included tumors larger than 5cm in maximum diameter that&#xD;
          showed considerable growth (imaging findings suggest that the diameter of the tumor has&#xD;
          increased by more than 1cm) in the preceding two years and were associated with persistent&#xD;
          hemangioma-related abdominal pain or discomfort. Alternatively, tumors measuring up to 5cm&#xD;
          in maximum diameter, exhibiting a pronounced growth propensity and located at the first,&#xD;
          second, or third hilar region in close proximity to the hilar bile duct, portal vein,&#xD;
          hepatic artery, hepatic vein, or inferior vena cava were also considered. And all these&#xD;
          patients cannot tolerate surgery due to other organ damage or do not want to undergo&#xD;
          surgical treatment.&#xD;
  &#xD;
          The ASA grade is II or III.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients with severe underlying medical conditions that could potentially prevent them from&#xD;
          tolerating the US-guided MWA procedure were ruled out.&#xD;
  &#xD;
          Those with tumors invading blood vessels, bile ducts, adjacent organs, or presenting with&#xD;
          extrahepatic metastasis were also excluded.&#xD;
  &#xD;
          Further, any cases presenting with uncorrectable coagulation disorders, thrombocytopenia,&#xD;
          or currently under administration of anticoagulant agents were deemed unfit for the study.&#xD;
  &#xD;
          Finally, patients were excluded if a safe trajectory for executing US-guided MWA was not&#xD;
          feasible.&#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>Man Lu, PHD</last_name>
      <role>Study Director</role>
      <affiliation>Sichuan Cancer Hospital and Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lu Wang</last_name>
      <phone>15828016725</phone>
      <email>656121781@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sichuan cancer hospital</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610041</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lu Wang</last_name>
        <phone>15828016725</phone>
        <email>656121781@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Sichuan Cancer Hospital and Research Institute</investigator_affiliation>
      <investigator_full_name>Lu Wang</investigator_full_name>
      <investigator_title>Attending physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT05990257
  org study id: CMRA123
  nct id: NCT05990257
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These
        patients were allocated into three groups based on tumor size and number: A, B, and C. Prior
        to the ablation procedure, Group A patients received a combination of hepatic hilar block
        (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group
        B were administered HHB in conjunction with LA, while those in Group C received TAPB and LA.
        Evaluative parameters included the Numerical Rating Scale (NRS) scores, consumption of
        morphine, incidence of complications, and factors influencing perioperative pain.
  Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These
        patients were allocated into three groups based on tumor size and number: A, B, and C. Prior
        to the ablation procedure, Group A patients received a combination of hepatic hilar block
        (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group
        B were administered HHB in conjunction with LA, while those in Group C received TAPB and
        LA.Pain levels were routinely assessed through the Numerical Rating Scale (NRS), with scores
        being recorded by the attending nurse every 15 minutes. The frequency of these assessments
        would be increased if the patient reported discomfort or if there were changes observed in
        vital signs. If a patient reported a pain level of ≥4 on the NRS scale, an intravenous dose
        of 10mg morphine was administered, provided that cardiopulmonary safety could be assured. The
        determination of cardiopulmonary safety was made by the interventional radiologist (M. L.
        with 20 years of experience). Following the ablation procedure, all patients were monitored
        for a period of 36 hours. During this period, several parameters were recorded at the time of
        the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure. These parameters
        included the NRS score, vital signs, any need for morphine, and the occurrence of any adverse
        events.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: pain control
  time frame: at the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure
  description: NRS score was used to evaluate pain control
  arm group label: HHB+TAPB+and LA
  arm group type: Experimental
  description: Group A: patients who received a HHB, TAPB, and LA
  arm group label: HHB+LA
  arm group type: Experimental
  description: Group B: patients who received HHB and LA
  arm group label: TAPB+LA
  arm group type: Experimental
  description: Group C: patients who received TAPB and LA
  intervention type: Procedure
  intervention name: HHB+TAPB+and LA
  description: Hepatic Hilar Block (HHB), Transversus Abdominis Plane Block (TAPB), and Local Anesthesia (LA)
  arm group label: HHB+TAPB+and LA
  intervention type: Procedure
  intervention name: HHB+LA
  description: Hepatic Hilar Block (HHB) and Local Anesthesia (LA)
  arm group label: HHB+LA
  intervention type: Procedure
  intervention name: TAPB+LA
  description: Transversus Abdominis Plane Block (TAPB) and Local Anesthesia (LA)
  arm group label: TAPB+LA
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Man Lu, PHD
  role: Study Director
  affiliation: Sichuan Cancer Hospital and Research Institute
  last name: Lu Wang
  phone: 15828016725
  email: 656121781@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Sichuan Cancer Hospital and Research Institute
  investigator full name: Lu Wang
  investigator title: Attending physician
  mesh term: Liver Neoplasms