<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/NCT04419246</url>
  </required_header>
  <id_info>
    <org_study_id>Bursa BYIERH</org_study_id>
    <nct_id>NCT04419246</nct_id>
  </id_info>
  <brief_title>The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy</brief_title>
  <official_title>The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy on Total Blood Loss; a Prospective, Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bursa Yüksek İhtisas Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bursa Yüksek İhtisas Education and Research Hospital</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>
      Nerve blocks are used for pain and surgery after many operations today. It has been&#xD;
      demonstrated by studies that the amount of postoperative bleeding decreases. On the other&#xD;
      hand, surgical teams can use additional medications, such as Tranexamic acid, which have been&#xD;
      proven by different studies that have reduced bleeding during and after arthroscopic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aimed to investigate the effect of interscalene block application and&#xD;
      tranexamic acid on bleeding in shoulder arthroscopy operation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 15, 2020</start_date>
  <completion_date type="Anticipated">July 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>serum hemoglobin exchange</measure>
    <time_frame>preoperative, postoperative 1st and 2nd day</time_frame>
    <description>change of serum hemoglobin before and after operation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative bleeding amount</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>The volume of drainage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>Postoperative 24 hours</time_frame>
    <description>Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0= no pain, 10=intolerable pain)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Nerve Block</condition>
  <condition>Tranexamic Acid</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>interscalene block + General anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group T</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tranexamic acid +General anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group S</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>General anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>interscalene block</intervention_name>
    <description>ultrasound guided ultrasound guided interscalene block 30 minutes before operation. 30 minutes before operation.</description>
    <arm_group_label>Group I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tranexamic acid</intervention_name>
    <description>10 mg/kg intravenous tranexamic acid 10 minutes before the incision.</description>
    <arm_group_label>Group T</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>general anesthesia</intervention_name>
    <description>general anesthesia will be applied in accordance with standard procedures</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group S</arm_group_label>
    <arm_group_label>Group T</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were in the American Society of Anesthesiologists (ASA) I-III class&#xD;
&#xD;
          -  underwent elective shoulder arthroscopy&#xD;
&#xD;
          -  Patients with consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of arterial or venous thromboembolic disease&#xD;
&#xD;
          -  Bleeding diathesis disorder&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  cardiac stent placement&#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_contact>
    <last_name>Korgün Ökmen, Assoc. PhD.</last_name>
    <phone>+902242955000</phone>
    <email>korgunokmen@gmail.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bursa Yüksek İhtisas Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Korgün Ökmen</investigator_full_name>
    <investigator_title>Principal Investigator ,Assoc. PhD. M.D.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranexamic Acid</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04419246
org study id: Bursa BYIERH
nct id: NCT04419246
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Nerve blocks are used for pain and surgery after many operations today. It has been
      demonstrated by studies that the amount of postoperative bleeding decreases. On the other
      hand, surgical teams can use additional medications, such as Tranexamic acid, which have been
      proven by different studies that have reduced bleeding during and after arthroscopic surgery.
The investigators aimed to investigate the effect of interscalene block application and
      tranexamic acid on bleeding in shoulder arthroscopy operation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: serum hemoglobin exchange
time frame: preoperative, postoperative 1st and 2nd day
description: change of serum hemoglobin before and after operation
measure: postoperative bleeding amount
time frame: postoperative 24 hours
description: The volume of drainage
measure: Visual Analog Scale
time frame: Postoperative 24 hours
description: Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0= no pain, 10=intolerable pain)
arm group label: Group I
arm group type: Active Comparator
description: interscalene block + General anesthesia
arm group label: Group T
arm group type: Active Comparator
description: Tranexamic acid +General anesthesia
arm group label: Group S
arm group type: Sham Comparator
description: General anesthesia
intervention type: Other
intervention name: interscalene block
description: ultrasound guided ultrasound guided interscalene block 30 minutes before operation. 30 minutes before operation.
arm group label: Group I
intervention type: Drug
intervention name: tranexamic acid
description: 10 mg/kg intravenous tranexamic acid 10 minutes before the incision.
arm group label: Group T
intervention type: Other
intervention name: general anesthesia
description: general anesthesia will be applied in accordance with standard procedures
arm group label: Group I
arm group label: Group S
arm group label: Group T
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Korgün Ökmen, Assoc. PhD.
phone: +902242955000
email: korgunokmen@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Bursa Yüksek İhtisas Education and Research Hospital
investigator full name: Korgün Ökmen
investigator title: Principal Investigator ,Assoc. PhD. M.D.
mesh term: Tranexamic Acid