<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/NCT02986997</url>
  </required_header>
  <id_info>
    <org_study_id>U/1/2016</org_study_id>
    <nct_id>NCT02986997</nct_id>
  </id_info>
  <brief_title>Over 2000 Epidural Anesthesias for Percutaneous Nephrolithotomy - a Retrospective Analysis</brief_title>
  <official_title>Over 2000 Procedures of Epidural Anesthesia for Percutaneous Nephrolithotomy - a Retrospective Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Percutaneous nephrolithotomy (PNL) is a renal lithiasis treatment. It is usually two staged:&#xD;
      it begins in the lithotomy position for ureteral catheter placement and retrograde&#xD;
      pyelography and, subsequently, an optimal renal access is obtained in the prone position. In&#xD;
      most of the centers, the PNL is done under general anesthesia (GA) that is associated with a&#xD;
      risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a&#xD;
      prone position. In our Department the procedure is usually performed under epidural&#xD;
      anesthesia. The aim of this study was to evaluate the epidural anesthesia performed for PNL&#xD;
      over the last decade in the Medical University of Warsaw Urology Department&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Percutaneous nephrolithotomy is a renal lithiasis endoscopic treatment. It is usually two&#xD;
      staged: it begins in the lithotomy position for ureteral catheter placement and retrograde&#xD;
      pyelography and, subsequently, an optimal renal access is obtained in the prone position. The&#xD;
      PNL is usually two staged. It begins in the lithotomy position for cystoscopic placement of&#xD;
      ureteral catheter and retrograde pyelography and, subsequently, a patient is placed mainly in&#xD;
      the prone position for percutaneous access and stone removal. This position offers more&#xD;
      options for puncture.&#xD;
&#xD;
      In most of the centers, the PNL is done under GA, that is associated with a risk of&#xD;
      complications due to putting an intubated, muscle-relaxed, unconscious patient in a prone&#xD;
      position. Other complications, including blood transfusion, nausea and vomiting or fever, are&#xD;
      more often observed after the general then after the regional anesthesia; the cost of general&#xD;
      anesthesia is also higher. The regional anesthesia that can be performed independently for&#xD;
      the PNL includes spinal, epidural or combined spinal-epidural blocks. A segmental epidural&#xD;
      block is better than spinal anesthesia in terms of hemodynamic stability, postoperative&#xD;
      analgesia, patient's satisfaction and reduced incidence of postoperative nausea and vomiting.&#xD;
      For epidural anesthesia it takes longer to act than for spinal one but it allows avoiding the&#xD;
      motor block so the patient can change the position from lithotomy into prone himself with a&#xD;
      little assistance. The position of a patient should not be changed rapidly right after the&#xD;
      spinal anesthesia has been performed, due to the risk of too high anesthesia level and&#xD;
      hemodynamic complications.&#xD;
&#xD;
      The aim of the study was to evaluate the epidural anesthesia performed for PNL over the last&#xD;
      decade in the Medical University of Warsaw Urology Department.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>effectiveness of epidural anesthesia for PNL evaluated by a number of participants having this procedure completed</measure>
    <time_frame>5 months</time_frame>
    <description>The investigator evaluates whether the procedure could be completely performed under epidural anesthesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epidural anesthesia complication rate evaluated by a number of vessel or spinal puncture</measure>
    <time_frame>5 months</time_frame>
    <description>The investigator counts all the vessel and spinal punctures done with the Tuohy needle</description>
  </secondary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Nephrolithiasis</condition>
  <condition>Anesthesia, Local</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that have PNL procedure performed in the Urology Department (Medical University of&#xD;
        Warsaw) 2005-2015&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PNL procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no PNL procedure&#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>Karolina Dobronska, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>I Department of Anaesthesiology and Intensive Care</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karolina Dobronska, MD</last_name>
    <phone>48 501323534</phone>
    <email>karolinapladzyk@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lidia I Jureczko, PhD MD</last_name>
    <phone>48 50054419</phone>
    <email>jureczko@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <address>
        <city>Warsaw</city>
        <zip>02-005</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>April 27, 2017</last_update_submitted>
  <last_update_submitted_qc>April 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Karolina Dobrońska</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>epidural anesthesia</keyword>
  <keyword>prone position</keyword>
  <keyword>percutaneous nephrolithotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Kidney Calculi</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02986997
org study id: U/1/2016
nct id: NCT02986997
lead sponsor: 
has dmc: No
Percutaneous nephrolithotomy (PNL) is a renal lithiasis treatment. It is usually two staged:
      it begins in the lithotomy position for ureteral catheter placement and retrograde
      pyelography and, subsequently, an optimal renal access is obtained in the prone position. In
      most of the centers, the PNL is done under general anesthesia (GA) that is associated with a
      risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a
      prone position. In our Department the procedure is usually performed under epidural
      anesthesia. The aim of this study was to evaluate the epidural anesthesia performed for PNL
      over the last decade in the Medical University of Warsaw Urology Department
Percutaneous nephrolithotomy is a renal lithiasis endoscopic treatment. It is usually two
      staged: it begins in the lithotomy position for ureteral catheter placement and retrograde
      pyelography and, subsequently, an optimal renal access is obtained in the prone position. The
      PNL is usually two staged. It begins in the lithotomy position for cystoscopic placement of
      ureteral catheter and retrograde pyelography and, subsequently, a patient is placed mainly in
      the prone position for percutaneous access and stone removal. This position offers more
      options for puncture.

      In most of the centers, the PNL is done under GA, that is associated with a risk of
      complications due to putting an intubated, muscle-relaxed, unconscious patient in a prone
      position. Other complications, including blood transfusion, nausea and vomiting or fever, are
      more often observed after the general then after the regional anesthesia; the cost of general
      anesthesia is also higher. The regional anesthesia that can be performed independently for
      the PNL includes spinal, epidural or combined spinal-epidural blocks. A segmental epidural
      block is better than spinal anesthesia in terms of hemodynamic stability, postoperative
      analgesia, patient's satisfaction and reduced incidence of postoperative nausea and vomiting.
      For epidural anesthesia it takes longer to act than for spinal one but it allows avoiding the
      motor block so the patient can change the position from lithotomy into prone himself with a
      little assistance. The position of a patient should not be changed rapidly right after the
      spinal anesthesia has been performed, due to the risk of too high anesthesia level and
      hemodynamic complications.

      The aim of the study was to evaluate the epidural anesthesia performed for PNL over the last
      decade in the Medical University of Warsaw Urology Department.
observational model: Other
time perspective: Retrospective
measure: effectiveness of epidural anesthesia for PNL evaluated by a number of participants having this procedure completed
time frame: 5 months
description: The investigator evaluates whether the procedure could be completely performed under epidural anesthesia
measure: Epidural anesthesia complication rate evaluated by a number of vessel or spinal puncture
time frame: 5 months
description: The investigator counts all the vessel and spinal punctures done with the Tuohy needle
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karolina Dobronska, MD
role: Principal Investigator
affiliation: I Department of Anaesthesiology and Intensive Care
last name: Karolina Dobronska, MD
phone: 48 501323534
email: karolinapladzyk@gmail.com
last name: Lidia I Jureczko, PhD MD
phone: 48 50054419
email: jureczko@gmail.com
facility: 
status: Recruiting
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Karolina Dobrońska
investigator title: MD
mesh term: Nephrolithiasis
mesh term: Kidney Calculi
sharing ipd: No