xml: <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/NCT06011421</url>
    </required_header>
    <id_info>
      <org_study_id>GS21/138922</org_study_id>
      <nct_id>NCT06011421</nct_id>
    </id_info>
    <brief_title>Wound Catheter Vs LA Bolus in Renal Transplant: RCT</brief_title>
    <official_title>Wound Catheter Vs LA Bolus in Renal Transplant: RCT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Leeds Teaching Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Leeds Teaching Hospitals NHS Trust</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Pain control is an important part of patients' care after a kidney transplant. Currently&#xD;
        patients receive a one off injection of Local Anaesthetic (LA) in the wound at the end of the&#xD;
        operation followed by Intravenous morphine through a Patient Controlled Analgesia System&#xD;
        (PCAS), a button pressed to provide a calculated dose with lock out times for safety.&#xD;
  &#xD;
        Through this study the aim to test the efficiency of Continuous Local Anaesthetic&#xD;
        Infiltration via Wound Catheter (LAWC) which is a method to deliver Local Anaesthetic over a&#xD;
        longer period of time after the operation. LAWC are currently in use in a variety of surgical&#xD;
        specialities including Liver surgery. Patients participating in this study will be allocated&#xD;
        randomly to one of 2 groups; one will receive LA at the end of the operation as per current&#xD;
        practice and one will receive LAWC. It then compare outcomes such as the the dose of morphine&#xD;
        required in the PCAS, quality of pain control and improvement in recovery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 31, 2022</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Total Dose of IV Morphine in the first 24 hours post op</measure>
      <time_frame>24 hours</time_frame>
      <description>Measurment of the dose delivered in 24 hours</description>
    </primary_outcome>
    <enrollment type="Anticipated">88</enrollment>
    <condition>Wound</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Local Anaesthetic Wound Catheter Insertion</intervention_name>
      <description>Use of the Local Anaesthetic Wound Catheter Insertion during kidney transplant</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing kidney transplant&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Primary kidney transplantation&#xD;
  &#xD;
            -  Single kidney transplantation&#xD;
  &#xD;
            -  Signed informed Consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Midline laparotomy&#xD;
  &#xD;
            -  Dual kidney transplantation&#xD;
  &#xD;
            -  Kidney re-transplantation&#xD;
  &#xD;
            -  Multi-organ transplantation&#xD;
  &#xD;
            -  Patients on Long term opiates&#xD;
  &#xD;
            -  Patients with psychiatric illness&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Sonsoles Martinez-Lopez</last_name>
      <phone>0113 243 3144</phone>
      <email>sonsoles.martinez-lopez@nhs.net</email>
    </overall_contact>
    <location>
      <facility>
        <name>Leeds Teaching Hospital NHS Trust</name>
        <address>
          <city>Leeds</city>
          <zip>LS7 4SA</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sonsoles Martinez-Lopez, MD FEBS</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Leeds Teaching Hospitals NHS Trust</name>
        <address>
          <city>Leeds</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</mesh_term>
      <mesh_term>Anesthetics, Local</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011421
  org study id: GS21/138922
  nct id: NCT06011421
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Pain control is an important part of patients' care after a kidney transplant. Currently
        patients receive a one off injection of Local Anaesthetic (LA) in the wound at the end of the
        operation followed by Intravenous morphine through a Patient Controlled Analgesia System
        (PCAS), a button pressed to provide a calculated dose with lock out times for safety.
  
        Through this study the aim to test the efficiency of Continuous Local Anaesthetic
        Infiltration via Wound Catheter (LAWC) which is a method to deliver Local Anaesthetic over a
        longer period of time after the operation. LAWC are currently in use in a variety of surgical
        specialities including Liver surgery. Patients participating in this study will be allocated
        randomly to one of 2 groups; one will receive LA at the end of the operation as per current
        practice and one will receive LAWC. It then compare outcomes such as the the dose of morphine
        required in the PCAS, quality of pain control and improvement in recovery.
  observational model: Case-Control
  time perspective: Prospective
  measure: Total Dose of IV Morphine in the first 24 hours post op
  time frame: 24 hours
  description: Measurment of the dose delivered in 24 hours
  intervention type: Device
  intervention name: Local Anaesthetic Wound Catheter Insertion
  description: Use of the Local Anaesthetic Wound Catheter Insertion during kidney transplant
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  last name: Sonsoles Martinez-Lopez
  phone: 0113 243 3144
  email: sonsoles.martinez-lopez@nhs.net
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Completed
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Wounds and Injuries
  mesh term: Anesthetics
  mesh term: Anesthetics, Local