<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/NCT01711450</url>
  </required_header>
  <id_info>
    <org_study_id>12-263-SDR</org_study_id>
    <nct_id>NCT01711450</nct_id>
  </id_info>
  <brief_title>Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures</brief_title>
  <official_title>Randomised Double Blind Controlled Study of the Effectiveness of Paravertebral Nerve Block in Decreasing Analgesia Requirements and Improving Patient Experience During Interventional Hepatic Procedures.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Richard Lindsay</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is aimed at assessing whether performing a paravertebral block (a type of regional&#xD;
      pain relief) can reduce the pain and anxiety patients experience during radiological&#xD;
      procedures on the liver.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Percutaneous procedures of the liver can be very painful and range from bliliary drain&#xD;
      insertions to tumor ablation procedures. The study will randomize patients in two groups, one&#xD;
      receiving a paravertebral nerve block prior to the procedure and one receiving a sham&#xD;
      procedure in which saline will be injected in the paravertebral space. Pain scores and use of&#xD;
      IV sedation will be monitored post procedure and both groups will be compared to assess&#xD;
      whether paravetebral nerve blocks are effective at reducing pain in patients receiving such&#xD;
      procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Institutional Ethics Board concern regarding sham procedure, requiring modifications that are&#xD;
    not feasible within the man-power limitations of our institution.&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose of intravenous sedation required during and after the procedure</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in analogue pain scoring after the procedure</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure duration</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate of liver procedure</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate of paravertebral block</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Liver Neoplasms</condition>
  <arm_group>
    <arm_group_label>Paravertebral block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paravertebral space will be needled and an anesthetic agent will be injected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control sham procedure</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Paravertebral space will be needled, but only normal saline injected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Paravertebral block</intervention_name>
    <description>Injection of local anaesthesia into paravertebral space to provide analgesia</description>
    <arm_group_label>Paravertebral block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control sham procedure</intervention_name>
    <description>Injection of Normal saline into the paravertebral space</description>
    <arm_group_label>Control sham procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of&#xD;
             enrollment.&#xD;
&#xD;
        Subjects referred for liver/biliary interventions to the angiography department.&#xD;
&#xD;
        Written informed consent to participate in the study. Ability to comply with the&#xD;
        requirements of the study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who participated in an active stage of any drug, intervention or treatment&#xD;
             trial within 30 days of enrollment.&#xD;
&#xD;
        Subjects with preexisting conditions, which, in the opinion of the investigator, interfere&#xD;
        with the conduct of the study. Patients will only be excluded on this basis following&#xD;
        discussion with another interventional radiologist.&#xD;
&#xD;
        Subjects who are uncooperative or cannot follow instructions. Mental state that may&#xD;
        preclude completion of the study procedure or ability to obtain informed consent.&#xD;
&#xD;
        Pregnant or nursing female subjects. Patient who are to undergo liver biopsy or routine&#xD;
        biliary tube exchange. Patients with neurological/spinal conditions, or a BMI over 40, that&#xD;
        would prevent safe/effective or well-targeted paravertebral blockade.&#xD;
&#xD;
        Patient unable to tolerate the paravertebral block procedure, for example due to inability&#xD;
        to lie prone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Lindsay, MB Bch</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Louis Boucher, MD</last_name>
    <role>Study Director</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Victoria Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 1A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>March 22, 2016</last_update_submitted>
  <last_update_submitted_qc>March 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Richard Lindsay</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</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/NCT01711450
org study id: 12-263-SDR
nct id: NCT01711450
lead sponsor: 
has dmc: No
This study is aimed at assessing whether performing a paravertebral block (a type of regional
      pain relief) can reduce the pain and anxiety patients experience during radiological
      procedures on the liver.
Percutaneous procedures of the liver can be very painful and range from bliliary drain
      insertions to tumor ablation procedures. The study will randomize patients in two groups, one
      receiving a paravertebral nerve block prior to the procedure and one receiving a sham
      procedure in which saline will be injected in the paravertebral space. Pain scores and use of
      IV sedation will be monitored post procedure and both groups will be compared to assess
      whether paravetebral nerve blocks are effective at reducing pain in patients receiving such
      procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Dose of intravenous sedation required during and after the procedure
time frame: 1 hour
measure: Improvement in analogue pain scoring after the procedure
time frame: 1 hour
measure: Procedure duration
time frame: 1 hour
measure: Complication rate of liver procedure
time frame: 24 hours
measure: Complication rate of paravertebral block
time frame: 1 hour
arm group label: Paravertebral block
arm group type: Experimental
description: Paravertebral space will be needled and an anesthetic agent will be injected.
arm group label: Control sham procedure
arm group type: Placebo Comparator
description: Paravertebral space will be needled, but only normal saline injected.
intervention type: Procedure
intervention name: Paravertebral block
description: Injection of local anaesthesia into paravertebral space to provide analgesia
arm group label: Paravertebral block
intervention type: Procedure
intervention name: Control sham procedure
description: Injection of Normal saline into the paravertebral space
arm group label: Control sham procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Richard Lindsay, MB Bch
role: Principal Investigator
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
last name: Louis Boucher, MD
role: Study Director
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
facility: 
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Richard Lindsay
investigator title: MD
mesh term: Liver Neoplasms
sharing ipd: No