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/NCT05968105</url>
    </required_header>
    <id_info>
      <org_study_id>e.mendes - 3</org_study_id>
      <secondary_id>KAEK/2023.06.260</secondary_id>
      <nct_id>NCT05968105</nct_id>
    </id_info>
    <brief_title>Changes in Vessels After Peripheral Block</brief_title>
    <official_title>Evaluation of Lateral Sagittal Infraclavicular Block According to Vena Cava Inferior Collapsibility Index (VCI-CI): An Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Basaksehir Cam &amp; Sakura Şehir Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Basaksehir Cam &amp; Sakura Şehir Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In patients with fluid deficit, vasoconstriction occurs in peripheral tissues and blood&#xD;
        circulation is kept in the central area. It causes arterial vasodilation and hemodynamic&#xD;
        variability by increasing the blood volume of the extremity due to the sympathectomy&#xD;
        occurring after the block. When the investigators classify patients according to VCI-CI, it&#xD;
        will be questioned whether there is a difference between patients' block quality and&#xD;
        hemodynamic variability.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        VCI-CI helps us to have an idea about the amount of fluid in patients according to the vena&#xD;
        cava Inferior (VCI) diameter and the diameter between the inspiring and expiration. Low&#xD;
        arterial diameter and high inspiratory and expiratory variability indicate that the patient's&#xD;
        fluid volume may be lower.&#xD;
  &#xD;
        In the measurement of VCI diameter, VCI has visualized in the craniocaudal plane thanks to&#xD;
        the transverse ultrasound probe. Changes in VCI diameter are observed depending on the&#xD;
        negative pressure in the thoracic area during inspiration and expiration. When the difference&#xD;
        between this rate of change is greater than 50%, it indicates that the patient has a fluid&#xD;
        deficit. The fact that the VCI diameter is also below 1.5 cm indicates that this amount of&#xD;
        fluid requirement is more serious. In this study, the investigators will question whether&#xD;
        there is a difference between patients' block quality and hemodynamic variability when they&#xD;
        classify patients according to VCI-CI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>3 Months</target_duration>
    <primary_outcome>
      <measure>Doppler flow change from baseline to postoperative period</measure>
      <time_frame>Perioperative period</time_frame>
      <description>Before the block, with the help of 8-12 mHz linear probe, the axillary artery of the patients will be determined in the lateral sagittal plane and their diameters at the time of systole and diastole will be determined. After the arterial diameters are determined, the probe will be positioned to view the artery in a linear line with 90 degree rotation. After imaging the axillary artery in the long axis, confirming it with 5 sequential flows in B-mode Doppler, PSV (Peak systolic velocity), EDV (End diastolic velocity), mV (mean velocity), RI index and PI index probe angulation at 30-60 degree angle, ultrasound will be measured automatically. After the block, the sensory and motor block times of the patients were determined and these times were recorded.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>VAS (Visual Analog Scala) score</measure>
      <time_frame>Postoperative 24th hour</time_frame>
      <description>The patients were followed up with a VAS score between 0-10 in the postoperative period. A VAS score of 0 was defined as no pain, and 10 as the most severe pain imaginable.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Analgesic consumption</measure>
      <time_frame>Postoperative 24th hour</time_frame>
      <description>he value in mg of the amount of analgesic consumed in the postoperative period. It was administered with a PCA device that had regular infusions and was able to deliver bolus doses at regular intervals</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative nausea and vomiting</measure>
      <time_frame>Postoperative 24th hour</time_frame>
      <description>The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Anesthesia, Local</condition>
    <condition>Vena Cava Syndrome (Inferior) (Superior)</condition>
    <condition>Fluid Loss</condition>
    <condition>Postoperative Pain</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>Inferior vena cava diameter &lt;1.5 cm and VCI-CI &gt; 50% according to Vena Cava Inferior Collapsibility Index (VCI-CI)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <description>Inferior vena cava diameter &gt;1.5 cm and VCI-CI &lt; 50% according to Vena Cava Inferior Collapsibility Index (VCI-CI)</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Lateral Sagittal Infraclavicular Block</intervention_name>
      <description>Patients will be in the supine position and after aseptic conditions are provided, the axillary artery of the patient will be visualized in the craniocaudal plane, in the infraclavicular region and in the lateral sagittal position with the help of an 8-12 mHz linear probe. After the brachial plexus cords around the axillary artery are identified, a local anesthetic mixture will be applied in-plane between the posterior cord and the artery. During the block, patients will routinely be given a mixture of 0.25% bupivacaine + 0.5% lidocaine 0.5 mL/kg.</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Inferior vena cava diameter &gt;1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) &lt; 50%</intervention_name>
      <description>While the patients are lying in the supine position, the vena cava will be determined 2 cm before the inferior heart entrance with the help of a 3.5-5 mHz convex probe. M-mode ECHO will be used to determine the fluctuation rate of the VCI between inspiration and expiration. After determining the farthest and closest points in M-mode ECO, their ratios to each other will be calculated.</description>
      <arm_group_label>Group 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Inferior vena cava diameter &lt;1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) &gt; 50%</intervention_name>
      <description>While the patients are lying in the supine position, the vena cava will be determined 2 cm before the inferior heart entrance with the help of a 3.5-5 mHz convex probe. M-mode ECHO will be used to determine the fluctuation rate of the VCI between inspiration and expiration. After determining the farthest and closest points in M-mode ECO, their ratios to each other will be calculated.</description>
      <arm_group_label>Group 1</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Block differences will be observed when patients who undergo routine hand surgery&#xD;
          operations under the lateral sagittal infraclavicular block are classified according to the&#xD;
          Vena Cava Inferior - Collapsibility Index.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Hand and Wrist elective surgery&#xD;
  &#xD;
            -  Infraclavicular block will be applied&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) physical condition I-II&#xD;
  &#xD;
            -  Patients aged 18-65 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindication for central or peripheral blocks&#xD;
  &#xD;
            -  Cognitive dysfunction&#xD;
  &#xD;
            -  History of chronic opioid use&#xD;
  &#xD;
            -  severe organ dysfunction&#xD;
  &#xD;
            -  Allergy to any drug used in the study&#xD;
  &#xD;
            -  Body mass index (BMI) ≥30&#xD;
  &#xD;
            -  Infection in the area to be treated&#xD;
  &#xD;
            -  Refusal to participate in the research&#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_official>
      <last_name>Ergun Mendes</last_name>
      <role>Principal Investigator</role>
      <affiliation>Basaksehir Cam &amp; Sakura Şehir Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ergun Mendes</last_name>
      <phone>+905514265012</phone>
      <email>erg.mendes@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ergun Mendes</name>
        <address>
          <city>Küçükçekmece</city>
          <state>İ̇stanbul</state>
          <zip>34000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ergun Mendes</last_name>
        <phone>+905514265012</phone>
        <email>erg.mendes@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Zhang H, Yuan H, Yu H, Zhang Y, Feng S. Correlation between pleth variability index and ultrasonic inferior vena cava-collapsibility index in parturients with twin pregnancies undergoing cesarean section under spinal anesthesia. Eur J Med Res. 2022 Aug 6;27(1):139. doi: 10.1186/s40001-022-00771-3.</citation>
      <PMID>35933431</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Basaksehir Cam &amp; Sakura Şehir Hospital</investigator_affiliation>
      <investigator_full_name>Ergün Mendeş</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Vena Cava Inferior Collapsibility Index</keyword>
    <keyword>Lateral Sagittal Infraclavicular Block</keyword>
    <keyword>VCI-CI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual participant data (IPD) will not be shared</ipd_description>
    </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/NCT05968105
  org study id: e.mendes - 3
  secondary id: KAEK/2023.06.260
  nct id: NCT05968105
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In patients with fluid deficit, vasoconstriction occurs in peripheral tissues and blood
        circulation is kept in the central area. It causes arterial vasodilation and hemodynamic
        variability by increasing the blood volume of the extremity due to the sympathectomy
        occurring after the block. When the investigators classify patients according to VCI-CI, it
        will be questioned whether there is a difference between patients' block quality and
        hemodynamic variability.
  VCI-CI helps us to have an idea about the amount of fluid in patients according to the vena
        cava Inferior (VCI) diameter and the diameter between the inspiring and expiration. Low
        arterial diameter and high inspiratory and expiratory variability indicate that the patient's
        fluid volume may be lower.
  
        In the measurement of VCI diameter, VCI has visualized in the craniocaudal plane thanks to
        the transverse ultrasound probe. Changes in VCI diameter are observed depending on the
        negative pressure in the thoracic area during inspiration and expiration. When the difference
        between this rate of change is greater than 50%, it indicates that the patient has a fluid
        deficit. The fact that the VCI diameter is also below 1.5 cm indicates that this amount of
        fluid requirement is more serious. In this study, the investigators will question whether
        there is a difference between patients' block quality and hemodynamic variability when they
        classify patients according to VCI-CI.
  observational model: Cohort
  time perspective: Prospective
  measure: Doppler flow change from baseline to postoperative period
  time frame: Perioperative period
  description: Before the block, with the help of 8-12 mHz linear probe, the axillary artery of the patients will be determined in the lateral sagittal plane and their diameters at the time of systole and diastole will be determined. After the arterial diameters are determined, the probe will be positioned to view the artery in a linear line with 90 degree rotation. After imaging the axillary artery in the long axis, confirming it with 5 sequential flows in B-mode Doppler, PSV (Peak systolic velocity), EDV (End diastolic velocity), mV (mean velocity), RI index and PI index probe angulation at 30-60 degree angle, ultrasound will be measured automatically. After the block, the sensory and motor block times of the patients were determined and these times were recorded.
  measure: VAS (Visual Analog Scala) score
  time frame: Postoperative 24th hour
  description: The patients were followed up with a VAS score between 0-10 in the postoperative period. A VAS score of 0 was defined as no pain, and 10 as the most severe pain imaginable.
  measure: Analgesic consumption
  time frame: Postoperative 24th hour
  description: he value in mg of the amount of analgesic consumed in the postoperative period. It was administered with a PCA device that had regular infusions and was able to deliver bolus doses at regular intervals
  measure: Postoperative nausea and vomiting
  time frame: Postoperative 24th hour
  description: The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.
  arm group label: Group 1
  description: Inferior vena cava diameter <1.5 cm and VCI-CI > 50% according to Vena Cava Inferior Collapsibility Index (VCI-CI)
  arm group label: Group 2
  description: Inferior vena cava diameter >1.5 cm and VCI-CI < 50% according to Vena Cava Inferior Collapsibility Index (VCI-CI)
  intervention type: Procedure
  intervention name: Lateral Sagittal Infraclavicular Block
  description: Patients will be in the supine position and after aseptic conditions are provided, the axillary artery of the patient will be visualized in the craniocaudal plane, in the infraclavicular region and in the lateral sagittal position with the help of an 8-12 mHz linear probe. After the brachial plexus cords around the axillary artery are identified, a local anesthetic mixture will be applied in-plane between the posterior cord and the artery. During the block, patients will routinely be given a mixture of 0.25% bupivacaine + 0.5% lidocaine 0.5 mL/kg.
  arm group label: Group 1
  arm group label: Group 2
  intervention type: Procedure
  intervention name: Inferior vena cava diameter >1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) < 50%
  description: While the patients are lying in the supine position, the vena cava will be determined 2 cm before the inferior heart entrance with the help of a 3.5-5 mHz convex probe. M-mode ECHO will be used to determine the fluctuation rate of the VCI between inspiration and expiration. After determining the farthest and closest points in M-mode ECO, their ratios to each other will be calculated.
  arm group label: Group 2
  intervention type: Diagnostic Test
  intervention name: Inferior vena cava diameter <1.5 cm and Vena Cava Inferior Collapsibility Index (VCI-CI) > 50%
  description: While the patients are lying in the supine position, the vena cava will be determined 2 cm before the inferior heart entrance with the help of a 3.5-5 mHz convex probe. M-mode ECHO will be used to determine the fluctuation rate of the VCI between inspiration and expiration. After determining the farthest and closest points in M-mode ECO, their ratios to each other will be calculated.
  arm group label: Group 1
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Ergun Mendes
  role: Principal Investigator
  affiliation: Basaksehir Cam & Sakura Şehir Hospital
  last name: Ergun Mendes
  phone: +905514265012
  email: erg.mendes@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Zhang H, Yuan H, Yu H, Zhang Y, Feng S. Correlation between pleth variability index and ultrasonic inferior vena cava-collapsibility index in parturients with twin pregnancies undergoing cesarean section under spinal anesthesia. Eur J Med Res. 2022 Aug 6;27(1):139. doi: 10.1186/s40001-022-00771-3.
  PMID: 35933431
  responsible party type: Principal Investigator
  investigator affiliation: Basaksehir Cam & Sakura Şehir Hospital
  investigator full name: Ergün Mendeş
  investigator title: Principal Investigator
  mesh term: Pain, Postoperative
  sharing ipd: No
  ipd description: Individual participant data (IPD) will not be shared