<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/NCT03018899</url>
  </required_header>
  <id_info>
    <org_study_id>PVB-TJ</org_study_id>
    <nct_id>NCT03018899</nct_id>
  </id_info>
  <brief_title>Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy</brief_title>
  <acronym>PVB</acronym>
  <official_title>Comparison of Paravertebral Block Versus Epidural Anesthesia for Surgical Anesthesia of Percutaneous Nephrolithotomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, randomized study is aimed to assess the efficacy and safety of&#xD;
      paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The&#xD;
      investigators suppose that paravertebral block is not inferior in controlling the&#xD;
      perioperative pain for percutaneous nephrolithotomy compared to epidural block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Percutaneous nephrolithotomy (PCNL) is generally performed under general or&#xD;
      neuraxial anesthesia. The investigators have reported three patients who were at high risk of&#xD;
      both general anesthesia and neuraxial anesthesia received percutaneous nephrolithotomy with&#xD;
      ultrasound guided paravertebral block. Then，The investigators performed ultrasound guided&#xD;
      paravertebral block for 45 patients who received percutaneous nephrolithotomy successfully.&#xD;
      The investigators' impression is that paravertebral block is as effective as epidural&#xD;
      anesthesia for surgical anesthesia of percutaneous nephrolithotomy.&#xD;
&#xD;
      Objectives:To assess the efficacy and safety of paravertebral block compared to epidural&#xD;
      anesthesia for surgical anesthesia of percutaneous nephrolithotomy.&#xD;
&#xD;
      Methods: Fifty adult patients undergoing elective percutaneous nephrolithotomy will be&#xD;
      randomized to receive ultrasound guided paravertebral block or epidural anesthesia. The&#xD;
      primary outcome will be the pain score 12h postoperation. The secondary outcomes will&#xD;
      include: time spent to perform block, dose of intraoperative opioids, rate of hypotension&#xD;
      need for vasoconstrictors, muscle Power Grading of the lower legs at the end of the&#xD;
      operation, anus exhaust time, opioid consumption postoperation, postoperative PONV score and&#xD;
      the frequency of vomiting , hospitalization duration and patient satisfaction.&#xD;
&#xD;
      Clinical Implications: Ultrasound guided paravertebral block could be an equally effective&#xD;
      and safe alternative to epidural block for surgical anesthesia of percutaneous&#xD;
      nephrolithotomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain score 12h post operation</measure>
    <time_frame>12 hours postoperation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>time spent to perform block</measure>
    <time_frame>during block</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dose of intraoperative opioids</measure>
    <time_frame>during operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of hypotension</measure>
    <time_frame>during operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Power Grading of the lower legs at the end of the operation</measure>
    <time_frame>12 hours postoperation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>opioid consumption postoperation</measure>
    <time_frame>12 hours postoperation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative PONV score and the frequency of vomiting</measure>
    <time_frame>24 hours postoperation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization duration</measure>
    <time_frame>10 days postoperation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>one day before discharge</time_frame>
    <description>Patient satisfaction will be evaluated by 5-point Likert scal</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Kidney Calculi</condition>
  <arm_group>
    <arm_group_label>paravertebral block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients received ultrasound guided two-segment paravertebral block for percutaneous nephrolithotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epidural</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients received thoracic epidural anesthesia for percutaneous nephrolithotomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>paravertebral block</intervention_name>
    <description>Ultrasound guided two-segment paravertebral block</description>
    <arm_group_label>paravertebral block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>epidural anesthesia</intervention_name>
    <description>thoracic epidural anesthesia</description>
    <arm_group_label>Epidural</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical statusⅠ-Ⅲ&#xD;
&#xD;
          -  Undergo first stage percutaneous nephrolithotomy&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI&gt;35&#xD;
&#xD;
          -  Coagulopathy, on anticoagulants&#xD;
&#xD;
          -  History of surgery on spine&#xD;
&#xD;
          -  Spine deformity&#xD;
&#xD;
          -  A known allergy to the drugs being used&#xD;
&#xD;
          -  Tumor or infection at the site of puncture&#xD;
&#xD;
          -  inability to provide adequate informed consent&#xD;
&#xD;
          -  refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Mei, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>October 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>October 28, 2019</last_update_submitted>
  <last_update_submitted_qc>October 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Wei Mei</investigator_full_name>
    <investigator_title>Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College</investigator_title>
  </responsible_party>
  <keyword>paravertebral block</keyword>
  <keyword>ultrasound</keyword>
  <keyword>percutaneous nephrolithotomy</keyword>
  <keyword>postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>For patient's privacy</ipd_description>
  </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/NCT03018899
org study id: PVB-TJ
nct id: NCT03018899
lead sponsor: 
has dmc: No
This prospective, randomized study is aimed to assess the efficacy and safety of
      paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The
      investigators suppose that paravertebral block is not inferior in controlling the
      perioperative pain for percutaneous nephrolithotomy compared to epidural block.
Background: Percutaneous nephrolithotomy (PCNL) is generally performed under general or
      neuraxial anesthesia. The investigators have reported three patients who were at high risk of
      both general anesthesia and neuraxial anesthesia received percutaneous nephrolithotomy with
      ultrasound guided paravertebral block. Then，The investigators performed ultrasound guided
      paravertebral block for 45 patients who received percutaneous nephrolithotomy successfully.
      The investigators' impression is that paravertebral block is as effective as epidural
      anesthesia for surgical anesthesia of percutaneous nephrolithotomy.

      Objectives:To assess the efficacy and safety of paravertebral block compared to epidural
      anesthesia for surgical anesthesia of percutaneous nephrolithotomy.

      Methods: Fifty adult patients undergoing elective percutaneous nephrolithotomy will be
      randomized to receive ultrasound guided paravertebral block or epidural anesthesia. The
      primary outcome will be the pain score 12h postoperation. The secondary outcomes will
      include: time spent to perform block, dose of intraoperative opioids, rate of hypotension
      need for vasoconstrictors, muscle Power Grading of the lower legs at the end of the
      operation, anus exhaust time, opioid consumption postoperation, postoperative PONV score and
      the frequency of vomiting , hospitalization duration and patient satisfaction.

      Clinical Implications: Ultrasound guided paravertebral block could be an equally effective
      and safe alternative to epidural block for surgical anesthesia of percutaneous
      nephrolithotomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pain score 12h post operation
time frame: 12 hours postoperation
measure: time spent to perform block
time frame: during block
measure: dose of intraoperative opioids
time frame: during operation
measure: rate of hypotension
time frame: during operation
measure: Muscle Power Grading of the lower legs at the end of the operation
time frame: 12 hours postoperation
measure: opioid consumption postoperation
time frame: 12 hours postoperation
measure: postoperative PONV score and the frequency of vomiting
time frame: 24 hours postoperation
measure: Hospitalization duration
time frame: 10 days postoperation
measure: Patient satisfaction
time frame: one day before discharge
description: Patient satisfaction will be evaluated by 5-point Likert scal
arm group label: paravertebral block
arm group type: Experimental
description: patients received ultrasound guided two-segment paravertebral block for percutaneous nephrolithotomy
arm group label: Epidural
arm group type: Active Comparator
description: patients received thoracic epidural anesthesia for percutaneous nephrolithotomy
intervention type: Procedure
intervention name: paravertebral block
description: Ultrasound guided two-segment paravertebral block
arm group label: paravertebral block
intervention type: Procedure
intervention name: epidural anesthesia
description: thoracic epidural anesthesia
arm group label: Epidural
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Wei Mei, Doctor
role: Study Director
affiliation: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Wei Mei
investigator title: Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Calculi
mesh term: Anesthetics
sharing ipd: No
ipd description: For patient's privacy