<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/NCT02198027</url>
  </required_header>
  <id_info>
    <org_study_id>TIH-Urology-001</org_study_id>
    <secondary_id>IRD_IRB_2014_01_002</secondary_id>
    <nct_id>NCT02198027</nct_id>
  </id_info>
  <brief_title>Peritubal Infiltration of Bupivacaine in PCNL</brief_title>
  <official_title>Role of Peritubal Infiltration of 0.25% Bupivacaine in Percutaneous Nephrolithotomy (PCNL) in Postoperative Pain Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indus Hospital and Health Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indus Hospital and Health Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients may feel significant pain at the surgery site after they wake up from the surgery.&#xD;
      Usually pain is managed in the ward by giving strong pain medication that may slow down your&#xD;
      mobilization and recovery process. Some recent work in other countries has shown that if&#xD;
      investigator give patients an injection at the end of the operation, patients have less need&#xD;
      for pain medication when they wake up. If investigator find that is also true in our&#xD;
      population, then we can use this method as routine step after this operation to improve pain&#xD;
      management and early mobilization of our patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean time for first demand of rescue analgesic</measure>
    <time_frame>Release of the patient from the hospital or 24 hours (whichever comes first)</time_frame>
    <description>Mean time for first demand defined as the difference in time between the first time rescue medications is given to patient in post-operatively and the time the infiltration took place intra-operatively</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Bupivacaine infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 ml of 0.25 % Bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline infiltration</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>10 ml of normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of 0.25 % Bupivacaine into renal capsule to skin.</description>
    <arm_group_label>Bupivacaine infiltration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal saline infiltration</intervention_name>
    <description>23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of normal saline into renal capsule to skin</description>
    <arm_group_label>Normal saline infiltration</arm_group_label>
    <other_name>normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-60 years of age&#xD;
&#xD;
          -  Single PCNL track&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Spinal Disc Prolapse&#xD;
&#xD;
          -  Any previous renal surgery&#xD;
&#xD;
          -  Complication secondary to PCNL&#xD;
&#xD;
               -  Hydrothorax that requires intervention&#xD;
&#xD;
               -  Pneumothorax&#xD;
&#xD;
               -  Massive hemorrhage that requires more than 1 U transfusion&#xD;
&#xD;
               -  Conversion to open procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zeeshan Arshad, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Indus Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zafar Zaidi, MBBS</last_name>
    <role>Study Director</role>
    <affiliation>The Indus Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zeeshan Arshad, MBBS</last_name>
    <email>zeeshandaa@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Naila Baig-Ansari, PhD</last_name>
    <email>naila.baig.ansari@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Indus Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sind</state>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Naila Baig-Ansari, PhD</last_name>
      <email>naila.baig.ansari@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Zeeshan Arshad, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zafar Zaidi, MBBS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>September 20, 2014</last_update_submitted>
  <last_update_submitted_qc>September 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indus Hospital and Health Network</investigator_affiliation>
    <investigator_full_name>Zeeshan Arshad</investigator_full_name>
    <investigator_title>Resident, Urology</investigator_title>
  </responsible_party>
  <keyword>Percutaneous nephrolithotomy</keyword>
  <keyword>postoperative analgesia</keyword>
  <keyword>peritubal block</keyword>
  <keyword>pain</keyword>
  <keyword>Visual Analog Pain Scale</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02198027
org study id: TIH-Urology-001
secondary id: IRD_IRB_2014_01_002
nct id: NCT02198027
lead sponsor: 
has dmc: Yes
Patients may feel significant pain at the surgery site after they wake up from the surgery.
      Usually pain is managed in the ward by giving strong pain medication that may slow down your
      mobilization and recovery process. Some recent work in other countries has shown that if
      investigator give patients an injection at the end of the operation, patients have less need
      for pain medication when they wake up. If investigator find that is also true in our
      population, then we can use this method as routine step after this operation to improve pain
      management and early mobilization of our patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Mean time for first demand of rescue analgesic
time frame: Release of the patient from the hospital or 24 hours (whichever comes first)
description: Mean time for first demand defined as the difference in time between the first time rescue medications is given to patient in post-operatively and the time the infiltration took place intra-operatively
arm group label: Bupivacaine infiltration
arm group type: Experimental
description: 10 ml of 0.25 % Bupivacaine
arm group label: Normal saline infiltration
arm group type: Placebo Comparator
description: 10 ml of normal saline
intervention type: Drug
intervention name: Bupivacaine
description: 23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of 0.25 % Bupivacaine into renal capsule to skin.
arm group label: Bupivacaine infiltration
intervention type: Other
intervention name: Normal saline infiltration
description: 23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of normal saline into renal capsule to skin
arm group label: Normal saline infiltration
other name: normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Zeeshan Arshad, MBBS
role: Principal Investigator
affiliation: The Indus Hospital
last name: Zafar Zaidi, MBBS
role: Study Director
affiliation: The Indus Hospital
last name: Zeeshan Arshad, MBBS
email: zeeshandaa@hotmail.com
last name: Naila Baig-Ansari, PhD
email: naila.baig.ansari@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Indus Hospital and Health Network
investigator full name: Zeeshan Arshad
investigator title: Resident, Urology
mesh term: Bupivacaine