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/NCT06040853</url>
    </required_header>
    <id_info>
      <org_study_id>traneksamicanalgesia</org_study_id>
      <nct_id>NCT06040853</nct_id>
    </id_info>
    <brief_title>Postoperative Pain in Laparoscopic Radical Prostatectomy Surgery With Tranexamic Acid: Analgesia? Hiperalgesia?</brief_title>
    <official_title>Evaluation of Postoperative Pain in Laparoscopic Radical Prostatectomy Surgery With Tranexamic Acid: Analgesia? Hiperalgesia?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dr. Lutfi Kirdar Kartal Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dr. Lutfi Kirdar Kartal Training and Research Hospital</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>
        Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a&#xD;
        surgery that significantly reduces disease-related mortality. The laparoscopic technique, on&#xD;
        the other hand, is preferred because it shortens the hospital stay, faster recovery and less&#xD;
        postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic&#xD;
        effects of tranexamic acid, which is widely used in the management of bleeding in trauma,&#xD;
        orthopedic, genitourinary and gynecological surgeries. Routine noninvasive monitoring (ECG,&#xD;
        Spo2, NIBP) will be performed when participatient are taken to the operating table without&#xD;
        premedication. After midazolam is administered, intubation will be performed by administering&#xD;
        1mg/kg lidocaine, 3mg/kg propofol, 2mcg/kg fentanyl, 0.6mg/kg rocuronium. Anesthesia will be&#xD;
        maintained with desflurane with a MAC of 1. A 0.1-0.5 mcg/kg/min remifentanil infusion will&#xD;
        be administered by targeting 40-60 values with BIS monitoring. After intubation, 15mg/kg&#xD;
        tranexamic acid will be given 10 minutes before the incision, and 100 mg/h infusion will be&#xD;
        administered until the skin is closed. The control group will be given 100 ml of&#xD;
        saline.1mg/kg tramadol and 1gr parol will be administered 30 minutes before the end of the&#xD;
        operation. The primary objectives of the study were to learn the VAS (Visual analog scale)&#xD;
        score at 0.6,12, 24,48,72 hours, time to first analgesic requirement, and analgesic&#xD;
        requirement within 24 hours. Secondary purposes are to determine the amount of antiemetic&#xD;
        used, at the beginning of the operation, Hg at the first hour and postoperative 6 hours,&#xD;
        complications and side effects (such as DVT, pulmonary embolism).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a&#xD;
        surgery that significantly reduces disease-related mortality. The laparoscopic technique, on&#xD;
        the other hand, is preferred because it shortens the hospital stay, faster recovery and less&#xD;
        postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic&#xD;
        effects of tranexamic acid, which is widely used in the management of bleeding in trauma,&#xD;
        orthopedic, genitourinary and gynecological surgeries&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual analog scale, time of first analgesic requirement, used within 24 hours amount of analgesic,</measure>
      <time_frame>Change from baseline at 0., 6., 12., 24., 48., 72. hours VAS score</time_frame>
      <description>Investigators will evaluate VAS score, time of first analgesic requirement, used within 24 hours amount of analgesic,</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>side effect, 0., 1., 6. hours hemogram value, amount of antiemetic used</measure>
      <time_frame>Change from baseline at 0., 1., 6. hours</time_frame>
      <description>Investigators will evaluate demographic characteristics [years, female/male, weight(kg),height(meter), BMI (kg/m2 )], side effect, 0,1,6 st hour hemogram value, amount of antiemetic used.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Pharmacological Action</condition>
    <arm_group>
      <arm_group_label>tranexamic group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After intubation, intravenous 15mg/kg tranexamic acid will be given to the study group 10 minutes before the incision and 100 mg/h infusion will be administered until the skin is closed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The control group will be given intravenous 100 ml of saline</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tranexamic acid intravenous administration</intervention_name>
      <description>Participants will be given 15mg/kg tranexamic acid before the incision in ten minutes, 100 mg/h will continue until the end of the surgery.</description>
      <arm_group_label>tranexamic group</arm_group_label>
      <other_name>intravenous saline administration</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Saline</intervention_name>
      <description>Participant was given intravenous 100 ml saline</description>
      <arm_group_label>placebo group</arm_group_label>
      <other_name>intravenous saline administration</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Elective laparoscopic radical prostatectomy will be performed; Surgeon with more than&#xD;
               10 years of laparoscopic prostatectomy experience&#xD;
  &#xD;
            -  Participant BMI(weight/height2)(kg/m2)&lt;35&#xD;
  &#xD;
            -  ASA2-3&#xD;
  &#xD;
            -  Participant Age&gt;18&#xD;
  &#xD;
            -  Participant Age&lt;75&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Coagulation disorder,&#xD;
  &#xD;
            -  Chronic renal failure,&#xD;
  &#xD;
            -  Patients allergic to tranexamic acid,&#xD;
  &#xD;
            -  Participant Age&lt;18&#xD;
  &#xD;
            -  Participant Age&gt;75,&#xD;
  &#xD;
            -  Participant BMI(weight/height2)(kg/m2)&gt;35,&#xD;
  &#xD;
            -  Surgeon with less than 10 years of laparoscopic prostatectomy experience,&#xD;
  &#xD;
            -  Patients who had a cerebral, coronary and thromboembolic event within 6 months before&#xD;
               the operation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gülten Arslan</last_name>
      <role>Study Director</role>
      <affiliation>DrLutfiKirdar training and research hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>gülten arslan, Assoc prof</last_name>
      <phone>+905323620366</phone>
      <phone_ext>2176</phone_ext>
      <email>gulten.arslan@yahoo.com.tr</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dr. Lutfi Kirdar Kartal Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Nihan Yaman Mammadov</investigator_full_name>
      <investigator_title>MD, principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tranexamic Acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <study_docs>
      <study_doc>
        <doc_id>doi: 10.1371</doc_id>
        <doc_type>Study Protocol</doc_type>
        <doc_url>https://pubmed.ncbi.nlm.nih.gov/28282425/</doc_url>
      </study_doc>
    </study_docs>
    <!-- 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/NCT06040853
  org study id: traneksamicanalgesia
  nct id: NCT06040853
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a
        surgery that significantly reduces disease-related mortality. The laparoscopic technique, on
        the other hand, is preferred because it shortens the hospital stay, faster recovery and less
        postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic
        effects of tranexamic acid, which is widely used in the management of bleeding in trauma,
        orthopedic, genitourinary and gynecological surgeries. Routine noninvasive monitoring (ECG,
        Spo2, NIBP) will be performed when participatient are taken to the operating table without
        premedication. After midazolam is administered, intubation will be performed by administering
        1mg/kg lidocaine, 3mg/kg propofol, 2mcg/kg fentanyl, 0.6mg/kg rocuronium. Anesthesia will be
        maintained with desflurane with a MAC of 1. A 0.1-0.5 mcg/kg/min remifentanil infusion will
        be administered by targeting 40-60 values with BIS monitoring. After intubation, 15mg/kg
        tranexamic acid will be given 10 minutes before the incision, and 100 mg/h infusion will be
        administered until the skin is closed. The control group will be given 100 ml of
        saline.1mg/kg tramadol and 1gr parol will be administered 30 minutes before the end of the
        operation. The primary objectives of the study were to learn the VAS (Visual analog scale)
        score at 0.6,12, 24,48,72 hours, time to first analgesic requirement, and analgesic
        requirement within 24 hours. Secondary purposes are to determine the amount of antiemetic
        used, at the beginning of the operation, Hg at the first hour and postoperative 6 hours,
        complications and side effects (such as DVT, pulmonary embolism).
  Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a
        surgery that significantly reduces disease-related mortality. The laparoscopic technique, on
        the other hand, is preferred because it shortens the hospital stay, faster recovery and less
        postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic
        effects of tranexamic acid, which is widely used in the management of bleeding in trauma,
        orthopedic, genitourinary and gynecological surgeries
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Visual analog scale, time of first analgesic requirement, used within 24 hours amount of analgesic,
  time frame: Change from baseline at 0., 6., 12., 24., 48., 72. hours VAS score
  description: Investigators will evaluate VAS score, time of first analgesic requirement, used within 24 hours amount of analgesic,
  measure: side effect, 0., 1., 6. hours hemogram value, amount of antiemetic used
  time frame: Change from baseline at 0., 1., 6. hours
  description: Investigators will evaluate demographic characteristics [years, female/male, weight(kg),height(meter), BMI (kg/m2 )], side effect, 0,1,6 st hour hemogram value, amount of antiemetic used.
  arm group label: tranexamic group
  arm group type: Experimental
  description: After intubation, intravenous 15mg/kg tranexamic acid will be given to the study group 10 minutes before the incision and 100 mg/h infusion will be administered until the skin is closed.
  arm group label: placebo group
  arm group type: Placebo Comparator
  description: The control group will be given intravenous 100 ml of saline
  intervention type: Drug
  intervention name: Tranexamic acid intravenous administration
  description: Participants will be given 15mg/kg tranexamic acid before the incision in ten minutes, 100 mg/h will continue until the end of the surgery.
  arm group label: tranexamic group
  other name: intravenous saline administration
  intervention type: Drug
  intervention name: Saline
  description: Participant was given intravenous 100 ml saline
  arm group label: placebo group
  other name: intravenous saline administration
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Gülten Arslan
  role: Study Director
  affiliation: DrLutfiKirdar training and research hospital
  last name: gülten arslan, Assoc prof
  phone: +905323620366
  phone ext: 2176
  email: gulten.arslan@yahoo.com.tr
  responsible party type: Principal Investigator
  investigator affiliation: Dr. Lutfi Kirdar Kartal Training and Research Hospital
  investigator full name: Nihan Yaman Mammadov
  investigator title: MD, principal investigator
  mesh term: Pain, Postoperative
  mesh term: Tranexamic Acid
  sharing ipd: No
  study doc: 