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/NCT06031129</url>
    </required_header>
    <id_info>
      <org_study_id>Jinling WBB</org_study_id>
      <nct_id>NCT06031129</nct_id>
    </id_info>
    <brief_title>Butorphanol in Pain Following Ablation for Hepatic Tumor</brief_title>
    <official_title>Effectiveness of Butorphanol in Alleviating Postoperative Visceral Pain Following Microwave Ablation for Hepatic Tumor: A Multicentral, Randomized, Placebo-Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bibo Wang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Eastern Hepatobiliary Surgery Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Jinling Hospital, China</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this investigation was to evaluate the influence of Butorphanol on&#xD;
        postoperative pain mitigation in patients undergoing microwave ablation for hepatic tumor.&#xD;
        Employing a rigorously designed multicentral, randomized, and placebo-controlled format,&#xD;
        patients subjected to microwave ablation were assigned randomly to either Butorphanol&#xD;
        (experimental group) or normal saline (control group). Primary outcomes encompassed&#xD;
        intraoperative pain levels assessed through patient-driven evaluation utilizing a 10-point&#xD;
        visual analog scale (VAS). Secondary outcomes included postoperative pain levels at the&#xD;
        6-hour mark (VAS) and comprehensive pain assessment outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Actual">August 9, 2023</completion_date>
    <primary_completion_date type="Actual">July 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>Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visceral Pain</measure>
      <time_frame>during the surgery</time_frame>
      <description>VAS score of visceral pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Visceral Pain</measure>
      <time_frame>6-hour after surgery</time_frame>
      <description>VAS score of visceral pain</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">300</enrollment>
    <condition>Visceral Pain</condition>
    <condition>Microwave Ablation</condition>
    <condition>Hepatic Tumor</condition>
    <arm_group>
      <arm_group_label>Butorphanol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>normal saline</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Butorphanol</intervention_name>
      <description>The pharmacological attributes of Butorphanol, characterized by its mild impact on cardiopulmonary dynamics and demonstrated efficacy in attenuating mechanical traction-induced discomfort, culminate in an ameliorative effect on postoperative nausea and vomiting rates. Importantly, it substantively attenuates visceral postoperative pain. However, sedation can also cause dizziness, drowsiness, and other adverse reactions during recovery</description>
      <arm_group_label>Butorphanol</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>normal saline</intervention_name>
      <description>normal saline contain 0.9% NaCl sodium.</description>
      <arm_group_label>normal saline</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          patients performing Microwave Ablation sign the informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients with a body mass index &gt; 30 kg/m2 a history of depression opioid dependence poorly&#xD;
          controlled hypertension (systolic blood pressure &gt; 180 mmHg) myocardial infarction severe&#xD;
          liver disease significant abdominal pain before surgery patients with sensory system or&#xD;
          language dysfunctions who could not cooperate to complete the scale pregnant women.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Jinling Hosipiatl</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>200000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
      <investigator_full_name>Bibo Wang</investigator_full_name>
      <investigator_title>Principal Investigator of Oncology Department</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Neoplasms</mesh_term>
      <mesh_term>Visceral Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Butorphanol</mesh_term>
    </intervention_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/NCT06031129
  org study id: Jinling WBB
  nct id: NCT06031129
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The objective of this investigation was to evaluate the influence of Butorphanol on
        postoperative pain mitigation in patients undergoing microwave ablation for hepatic tumor.
        Employing a rigorously designed multicentral, randomized, and placebo-controlled format,
        patients subjected to microwave ablation were assigned randomly to either Butorphanol
        (experimental group) or normal saline (control group). Primary outcomes encompassed
        intraoperative pain levels assessed through patient-driven evaluation utilizing a 10-point
        visual analog scale (VAS). Secondary outcomes included postoperative pain levels at the
        6-hour mark (VAS) and comprehensive pain assessment outcomes.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Visceral Pain
  time frame: during the surgery
  description: VAS score of visceral pain
  measure: Visceral Pain
  time frame: 6-hour after surgery
  description: VAS score of visceral pain
  arm group label: Butorphanol
  arm group type: Experimental
  arm group label: normal saline
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Butorphanol
  description: The pharmacological attributes of Butorphanol, characterized by its mild impact on cardiopulmonary dynamics and demonstrated efficacy in attenuating mechanical traction-induced discomfort, culminate in an ameliorative effect on postoperative nausea and vomiting rates. Importantly, it substantively attenuates visceral postoperative pain. However, sedation can also cause dizziness, drowsiness, and other adverse reactions during recovery
  arm group label: Butorphanol
  intervention type: Drug
  intervention name: normal saline
  description: normal saline contain 0.9% NaCl sodium.
  arm group label: normal saline
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Jinling Hospital, China
  investigator full name: Bibo Wang
  investigator title: Principal Investigator of Oncology Department
  mesh term: Liver Neoplasms
  mesh term: Visceral Pain
  mesh term: Butorphanol