<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/NCT02228330</url>
  </required_header>
  <id_info>
    <org_study_id>0063-14-RMC</org_study_id>
    <nct_id>NCT02228330</nct_id>
  </id_info>
  <brief_title>Prospective Clinical Trial - Obturator Reflex Predictors and Blockage</brief_title>
  <official_title>Prospective Clinical Trial - Obturator Reflex Predictors and Blockage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to estimate the incidence rate of obturator nerve reflex and leg&#xD;
      jerking during Transurethral Resections of Bladder Tumors (TURBTs), evaluate the efficacy of&#xD;
      obturator nerve block in the prevention of inadvertent muscle spasm, and to identify&#xD;
      predictors for both the jerking reflex and successful nerve block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: A single center single arm prospective study aiming to estimate the incidence&#xD;
      rate of obturator nerve reflex and leg jerking during TURBTs, evaluate the efficacy of&#xD;
      obturator nerve block (ONB) in the prevention of inadvertent muscle spasm, and identify&#xD;
      predictors for both the jerking reflex and successful nerve block.&#xD;
&#xD;
      Study population: patients who are scheduled for TUR for bladder tumor, as standard care, who&#xD;
      are willing and able to participate in the study&#xD;
&#xD;
      Intervention: a uni-lateral ONB (using Lidocaine 2%)&#xD;
&#xD;
      Study outline: Once in the operating room patients will be monitored by continuous&#xD;
      electrocardiography, non-invasive arterial blood pressure measurement, and pulse oximetry in&#xD;
      the usual manner. They will then undergo general or spinal anesthesia according to their&#xD;
      preference and at the discretion of the treating anesthesiologist, without the use of muscle&#xD;
      relaxants. As part of the study, a uni-lateral ONB will be performed under ultrasound&#xD;
      guidance- using 2% lidocaine for obtaining a short term block, for the duration of the&#xD;
      procedure itself. The non-blocked nerve will be used as control. The surgeon will be blinded&#xD;
      as to the side in which the ONB has been performed. A catheter will be used to fill the&#xD;
      bladder with saline to its full capacity. The inner wall of the bladder will then be&#xD;
      stimulated to test for an obturator nerve reflex and leg jerking. Stimulation will be done&#xD;
      using a trans-resectoscope and a single-twitch electrical current generated by a&#xD;
      neuromuscular monitoring device, as previously described by Mihara et al. Four different&#xD;
      bladder volumes will be tested. For each bladder volume, a reflex response on both sides will&#xD;
      be documented and graded. The investigators will then proceed with a TUR in the usual manner.&#xD;
&#xD;
      Primary endpoints: frequency of obturator jerk reflex and efficacy of obturator nerve block&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>efficacy of obturator nerve block in preventing inadvertent obturator jerk</measure>
    <time_frame>intraoperative</time_frame>
    <description>percentage of subjects for which the obtorator nerve block prevnted inadvertent obturator jerk</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence rate of obturator nerve jerk reflex</measure>
    <time_frame>end of study (one year)</time_frame>
    <description>frequency of obturator nerve jerk reflex</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Malignant Neoplasm of Urinary Bladder</condition>
  <arm_group>
    <arm_group_label>uni-lateral obturator nerve block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients scheduled for TUR for bladder tumor Intervention: uni-lateral obturator nerve block.&#xD;
non-blocked obtorator side of each patient will be used as control</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>obturator nerve block</intervention_name>
    <description>a uni-lateral obturator nerve block will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block.</description>
    <arm_group_label>uni-lateral obturator nerve block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient, older than 18 yo, scheduled for TUR for bladder tumor.&#xD;
&#xD;
          -  The subject is willing and able to read, understand and sign the study specific&#xD;
             informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known coagulopathy, including patients receiving antithrombotic or&#xD;
             thrombolytic therapy not in compliance with standard precautions.&#xD;
&#xD;
          -  Patients with a known allergy to anesthetics.&#xD;
&#xD;
          -  Patients who underwent partial cystectomy.&#xD;
&#xD;
          -  Patients with tumors involving bladder diverticula.&#xD;
&#xD;
          -  Patients with pre-existing obturator nerve injury or pre-existing neurologic deficits.&#xD;
&#xD;
          -  Patients with neuromuscular disease.&#xD;
&#xD;
          -  Patients with local infection above planned ONB site.&#xD;
&#xD;
          -  Patients in whom the use of muscle relaxants is deemed necessary by the&#xD;
             anesthesiologist.&#xD;
&#xD;
          -  Patients with inguinal lymphadenopathy.&#xD;
&#xD;
          -  Patients unable to sign an informed consent form.&#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>David Margel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rabin Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petach-Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>October 15, 2017</last_update_submitted>
  <last_update_submitted_qc>October 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transurethral resection of bladder tumors</keyword>
  <keyword>Obturator nerve reflex</keyword>
  <keyword>Obturator nerve block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02228330
org study id: 0063-14-RMC
nct id: NCT02228330
lead sponsor: 
has dmc: Yes
The aim of this study is to estimate the incidence rate of obturator nerve reflex and leg
      jerking during Transurethral Resections of Bladder Tumors (TURBTs), evaluate the efficacy of
      obturator nerve block in the prevention of inadvertent muscle spasm, and to identify
      predictors for both the jerking reflex and successful nerve block.
Study design: A single center single arm prospective study aiming to estimate the incidence
      rate of obturator nerve reflex and leg jerking during TURBTs, evaluate the efficacy of
      obturator nerve block (ONB) in the prevention of inadvertent muscle spasm, and identify
      predictors for both the jerking reflex and successful nerve block.

      Study population: patients who are scheduled for TUR for bladder tumor, as standard care, who
      are willing and able to participate in the study

      Intervention: a uni-lateral ONB (using Lidocaine 2%)

      Study outline: Once in the operating room patients will be monitored by continuous
      electrocardiography, non-invasive arterial blood pressure measurement, and pulse oximetry in
      the usual manner. They will then undergo general or spinal anesthesia according to their
      preference and at the discretion of the treating anesthesiologist, without the use of muscle
      relaxants. As part of the study, a uni-lateral ONB will be performed under ultrasound
      guidance- using 2% lidocaine for obtaining a short term block, for the duration of the
      procedure itself. The non-blocked nerve will be used as control. The surgeon will be blinded
      as to the side in which the ONB has been performed. A catheter will be used to fill the
      bladder with saline to its full capacity. The inner wall of the bladder will then be
      stimulated to test for an obturator nerve reflex and leg jerking. Stimulation will be done
      using a trans-resectoscope and a single-twitch electrical current generated by a
      neuromuscular monitoring device, as previously described by Mihara et al. Four different
      bladder volumes will be tested. For each bladder volume, a reflex response on both sides will
      be documented and graded. The investigators will then proceed with a TUR in the usual manner.

      Primary endpoints: frequency of obturator jerk reflex and efficacy of obturator nerve block
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: efficacy of obturator nerve block in preventing inadvertent obturator jerk
time frame: intraoperative
description: percentage of subjects for which the obtorator nerve block prevnted inadvertent obturator jerk
measure: incidence rate of obturator nerve jerk reflex
time frame: end of study (one year)
description: frequency of obturator nerve jerk reflex
arm group label: uni-lateral obturator nerve block
arm group type: Experimental
description: Patients scheduled for TUR for bladder tumor Intervention: uni-lateral obturator nerve block.
non-blocked obtorator side of each patient will be used as control
intervention type: Procedure
intervention name: obturator nerve block
description: a uni-lateral obturator nerve block will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block.
arm group label: uni-lateral obturator nerve block
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Margel, MD, PhD
role: Principal Investigator
affiliation: Rabin Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Urinary Bladder Neoplasms
sharing ipd: Undecided