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/NCT06041425</url>
    </required_header>
    <id_info>
      <org_study_id>2023-SR-093</org_study_id>
      <nct_id>NCT06041425</nct_id>
    </id_info>
    <brief_title>The Effects of Oxycodone Versus Sufentanil on Pain and Inflammatory Response After TACE</brief_title>
    <official_title>The Effects of Single Dose Oxycodone Versus Sufentanil on Pain and Inflammatory Response After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma: a Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital with Nanjing Medical University</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 purpose of this randomized, double-blind trial was to compare the effects of preemptive&#xD;
        Oxycodone and sufentanil at the same dose on pain and inflammatory response after&#xD;
        transcatheter arterial chemoembolization (TACE) of hepatocellular carcinoma. To study the&#xD;
        effect of single dose intravenous injection of Oxycodone and sufentanil before TACE on&#xD;
        inflammatory reaction after TACE; And (ii) evaluate the effects of different opioid drugs on&#xD;
        pain and nausea/vomiting after TACE.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Transcatheter arterial chemoembolization (TACE) is currently considered as the treatment for&#xD;
        unresectable hepatocellular carcinoma (HCC). Due to sudden blockage of the main blood vessels&#xD;
        supplying the tumor, local liver tissue swells and the tumor rapidly necroses. A large number&#xD;
        of inflammatory mediators, including white blood cell (WBC) count, C-reactive protein (CRP)&#xD;
        and Interleukin 6 (IL-6), will inevitably appear in TACE induced ischemic and/or necrotic&#xD;
        tissue reactions, which contribute to the development of pain. Pain can worsen the patient's&#xD;
        quality of life, prolong hospital stay, and increase costs. 93% of patients require opioid&#xD;
        therapy during and after TACE.&#xD;
  &#xD;
        Opioids are the most common drugs for treating pain. There are three types of opioid&#xD;
        receptors, μ Receptors κ Receptors and δ Receptors. Sufentanil is a highly selective drug μ&#xD;
        Receptor agonists have fast onset and strong analgesic effects. However, sufentanil is not as&#xD;
        effective as Oxycodone in relieving visceral pain. Oxycodone not only activates μ receptors,&#xD;
        also occupying κ receptors, alleviate visceral ischemic pain and inflammatory reactions.&#xD;
  &#xD;
        In addition to the type of medication, the administration time can also affect perioperative&#xD;
        pain. Preemptive analgesia refers to the intervention of pain relief before nociceptive&#xD;
        stimuli to suppress the progression of stress states and central sensitization.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Intraoperative pain intensity during TACE.</measure>
      <time_frame>Intraoperative (From the beginning of TACE to the end of TACE.)</time_frame>
      <description>Pain intensity is assessed by numerical rating scale pain scores (0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain intensity at 1hour after the end of TACE.</measure>
      <time_frame>From 0 to 1 hour after the end of TACE.</time_frame>
      <description>Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain intensity at 6hours after the end of TACE.</measure>
      <time_frame>From 1hour to 6 hours after the end of TACE.</time_frame>
      <description>Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain intensity at 12hours after the end of TACE.</measure>
      <time_frame>From 6hours to 12 hours after the end of TACE.</time_frame>
      <description>Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain intensity at 24hours after the end of TACE.</measure>
      <time_frame>From 12 hours to 24 hours after the end of TACE.</time_frame>
      <description>Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The WBC count</measure>
      <time_frame>24 hours</time_frame>
      <description>The WBC count in 10^9/L. Inflammatory reactions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neutrophil percentage</measure>
      <time_frame>24 hours</time_frame>
      <description>neutrophil percentage in %.&#xD;
  Inflammatory reactions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Level of CRP</measure>
      <time_frame>24 hours</time_frame>
      <description>CRP in mg/L.&#xD;
  Inflammatory reaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Level of IL-6</measure>
      <time_frame>24 hours</time_frame>
      <description>IL-6 in pg/mL.&#xD;
  Inflammatory reaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nausea and vomiting scale</measure>
      <time_frame>24 hours</time_frame>
      <description>Nausea and vomiting were graded on a four-point scale, 0,no nausea.1,mild nausea. 2,severe nausea requiring antiemetics. and 3, retching and/or vomiting.)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <condition>Transcatheter Arterial Chemoembolization</condition>
    <condition>Pain</condition>
    <condition>Inflammation</condition>
    <arm_group>
      <arm_group_label>Oxycodone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients were given 0.1mg/kg oxycodone 15 minutes before transcatheter arterial chemoembolization (TACE).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sufentanil</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patients were given 0.1μg/kg sufentanil 15 minutes before transcatheter arterial chemoembolization (TACE).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oxycodone</intervention_name>
      <description>The patients were given 0.1mg/kg oxycodone 15 minutes before transcatheter arterial chemoembolization (TACE). WBC count, neutrophil percentage, CRP, and IL-6 were used as inflammatory markers and measured before TACE (1 day before TACE) and 24 hours after TACE. Assess pain and side effects during TACE and within 24 hours after TACE. Pain was evaluated using the 11 point Numeric Rating Scale (NRS).</description>
      <arm_group_label>Oxycodone</arm_group_label>
      <other_name>preemptive analgesia</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sufentanil</intervention_name>
      <description>The patients were given 0.1μg/kg sufentanil 15 minutes before transcatheter arterial chemoembolization (TACE). WBC count, neutrophil percentage, CRP, and IL-6 were used as inflammatory markers and measured before TACE (1 day before TACE) and 24 hours after TACE. Assess pain and side effects during TACE and within 24 hours after TACE. Pain was evaluated using the 11 point Numeric Rating Scale (NRS).</description>
      <arm_group_label>Sufentanil</arm_group_label>
      <other_name>preemptive analgesia</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years;&#xD;
  &#xD;
            -  Presence of histologically confirmed or clinically diagnosed hepatocellular carcinoma&#xD;
               (fulfilling the criteria for lesions with typical imaging);&#xD;
  &#xD;
            -  Presence of Child-Pugh class A or B disease;&#xD;
  &#xD;
            -  Absence of benefit from a treatment of established efficacy such as resection and&#xD;
               local ablation;&#xD;
  &#xD;
            -  ECOG:0-2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Extrahepatic metastasis and/or microvascular invasion;&#xD;
  &#xD;
            -  Severe liver and kidney dysfunction;&#xD;
  &#xD;
            -  Uncontrolled or significant cardiovascular disease; Autoimmune hepatitis; Long term&#xD;
               use of opioids, steroid hormones, and non steroidal anti-inflammatory drugs; Abnormal&#xD;
               elevation of C-reactive protein (CRP); Increased white blood cells (&gt;11000/mm3); Study&#xD;
               Drugs allergy; Patients who were treated within 4 weeks after COVID-19 infection was&#xD;
               diagnosed.&#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_official>
      <last_name>Yu CHEN, MD</last_name>
      <role>Study Chair</role>
      <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wentao WU, MD</last_name>
      <phone>15251836687 ext +86</phone>
      <phone_ext>02568306918</phone_ext>
      <email>doctorwuwentao@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital with Nanjing Medical University</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210029</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wentao WU, MD</last_name>
        <phone>（+86）15251836687</phone>
        <email>doctorwuwentao@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 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>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sufentanil</mesh_term>
      <mesh_term>Oxycodone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The individual participant data for this study is available from the sponsor on reasonable request through email.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>August 2023 to August 2024</ipd_time_frame>
      <ipd_access_criteria>Within one year</ipd_access_criteria>
    </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/NCT06041425
  org study id: 2023-SR-093
  nct id: NCT06041425
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this randomized, double-blind trial was to compare the effects of preemptive
        Oxycodone and sufentanil at the same dose on pain and inflammatory response after
        transcatheter arterial chemoembolization (TACE) of hepatocellular carcinoma. To study the
        effect of single dose intravenous injection of Oxycodone and sufentanil before TACE on
        inflammatory reaction after TACE; And (ii) evaluate the effects of different opioid drugs on
        pain and nausea/vomiting after TACE.
  Transcatheter arterial chemoembolization (TACE) is currently considered as the treatment for
        unresectable hepatocellular carcinoma (HCC). Due to sudden blockage of the main blood vessels
        supplying the tumor, local liver tissue swells and the tumor rapidly necroses. A large number
        of inflammatory mediators, including white blood cell (WBC) count, C-reactive protein (CRP)
        and Interleukin 6 (IL-6), will inevitably appear in TACE induced ischemic and/or necrotic
        tissue reactions, which contribute to the development of pain. Pain can worsen the patient's
        quality of life, prolong hospital stay, and increase costs. 93% of patients require opioid
        therapy during and after TACE.
  
        Opioids are the most common drugs for treating pain. There are three types of opioid
        receptors, μ Receptors κ Receptors and δ Receptors. Sufentanil is a highly selective drug μ
        Receptor agonists have fast onset and strong analgesic effects. However, sufentanil is not as
        effective as Oxycodone in relieving visceral pain. Oxycodone not only activates μ receptors,
        also occupying κ receptors, alleviate visceral ischemic pain and inflammatory reactions.
  
        In addition to the type of medication, the administration time can also affect perioperative
        pain. Preemptive analgesia refers to the intervention of pain relief before nociceptive
        stimuli to suppress the progression of stress states and central sensitization.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Intraoperative pain intensity during TACE.
  time frame: Intraoperative (From the beginning of TACE to the end of TACE.)
  description: Pain intensity is assessed by numerical rating scale pain scores (0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).
  measure: Pain intensity at 1hour after the end of TACE.
  time frame: From 0 to 1 hour after the end of TACE.
  description: Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).
  measure: Pain intensity at 6hours after the end of TACE.
  time frame: From 1hour to 6 hours after the end of TACE.
  description: Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).
  measure: Pain intensity at 12hours after the end of TACE.
  time frame: From 6hours to 12 hours after the end of TACE.
  description: Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).
  measure: Pain intensity at 24hours after the end of TACE.
  time frame: From 12 hours to 24 hours after the end of TACE.
  description: Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome).
  measure: The WBC count
  time frame: 24 hours
  description: The WBC count in 10^9/L. Inflammatory reactions
  measure: Neutrophil percentage
  time frame: 24 hours
  description: neutrophil percentage in %.
  Inflammatory reactions
  measure: Level of CRP
  time frame: 24 hours
  description: CRP in mg/L.
  Inflammatory reaction
  measure: Level of IL-6
  time frame: 24 hours
  description: IL-6 in pg/mL.
  Inflammatory reaction
  measure: Nausea and vomiting scale
  time frame: 24 hours
  description: Nausea and vomiting were graded on a four-point scale, 0,no nausea.1,mild nausea. 2,severe nausea requiring antiemetics. and 3, retching and/or vomiting.)
  arm group label: Oxycodone
  arm group type: Experimental
  description: The patients were given 0.1mg/kg oxycodone 15 minutes before transcatheter arterial chemoembolization (TACE).
  arm group label: Sufentanil
  arm group type: Active Comparator
  description: The patients were given 0.1μg/kg sufentanil 15 minutes before transcatheter arterial chemoembolization (TACE).
  intervention type: Drug
  intervention name: Oxycodone
  description: The patients were given 0.1mg/kg oxycodone 15 minutes before transcatheter arterial chemoembolization (TACE). WBC count, neutrophil percentage, CRP, and IL-6 were used as inflammatory markers and measured before TACE (1 day before TACE) and 24 hours after TACE. Assess pain and side effects during TACE and within 24 hours after TACE. Pain was evaluated using the 11 point Numeric Rating Scale (NRS).
  arm group label: Oxycodone
  other name: preemptive analgesia
  intervention type: Drug
  intervention name: Sufentanil
  description: The patients were given 0.1μg/kg sufentanil 15 minutes before transcatheter arterial chemoembolization (TACE). WBC count, neutrophil percentage, CRP, and IL-6 were used as inflammatory markers and measured before TACE (1 day before TACE) and 24 hours after TACE. Assess pain and side effects during TACE and within 24 hours after TACE. Pain was evaluated using the 11 point Numeric Rating Scale (NRS).
  arm group label: Sufentanil
  other name: preemptive analgesia
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yu CHEN, MD
  role: Study Chair
  affiliation: The First Affiliated Hospital with Nanjing Medical University
  last name: Wentao WU, MD
  phone: 15251836687 ext +86
  phone ext: 02568306918
  email: doctorwuwentao@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  mesh term: Inflammation
  mesh term: Sufentanil
  mesh term: Oxycodone
  sharing ipd: Yes
  ipd description: The individual participant data for this study is available from the sponsor on reasonable request through email.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: August 2023 to August 2024
  ipd access criteria: Within one year