<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/NCT01679106</url>
  </required_header>
  <id_info>
    <org_study_id>12-559</org_study_id>
    <nct_id>NCT01679106</nct_id>
  </id_info>
  <brief_title>The Effects of Continuous Transversus Abdominis Plane (TAP) Catheters on Postoperative Pain After Renal Transplantation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up to 174 patients undergoing renal transplantation will be randomized to one of two groups.&#xD;
      Randomization will be based on computer-generated codes using random block sizes ranging from&#xD;
      4 to 8.&#xD;
&#xD;
      Group 1: TAP catheter with continuous infusion of Ropivicaine Group 2: Fentanyl IV PCA&#xD;
&#xD;
      The TAP catheter will be removed 48 hours postoperatively. Following removal, the pain scores&#xD;
      will be assessed at 60 and 72 hours postoperatively to determine any prolonged analgesic&#xD;
      benefit. In addition, the presence of any pain at the incision site will be noted at the 1&#xD;
      month surgical follow-up to determine any evidence of chronic pain.&#xD;
&#xD;
      The investigators hypothesis is that unilateral kidney transplant patients with a continuous&#xD;
      TAP catheter will have decreased pain scores and opioid usage compared to those receiving&#xD;
      standard analgesic therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study closed because of low enrolment&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of continuous TAP analgesia and pain scores</measure>
    <time_frame>day 1</time_frame>
    <description>The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of TAP analgesia and opioid requirements</measure>
    <time_frame>Day 1</time_frame>
    <description>The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of continuous TAP analgesia on pain scores</measure>
    <time_frame>Day 2</time_frame>
    <description>The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of continuous TAP analgesia on pain scores</measure>
    <time_frame>Day 3</time_frame>
    <description>The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of continuous TAP analgesia on pain scores</measure>
    <time_frame>30 days</time_frame>
    <description>The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of TAP analgesia on opioid requirements</measure>
    <time_frame>Day 2</time_frame>
    <description>The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of TAP analgesia on opioid requirements</measure>
    <time_frame>Day 3</time_frame>
    <description>The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of TAP analgesia on opioid requirements</measure>
    <time_frame>Day 30</time_frame>
    <description>The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Fentanyl IV PCA and placebo TAP catheter</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive Fentanyl IV PCA and placebo TAP catheter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAP catheter with continuous infusion of Ropivicaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive TAP catheter with continuous infusion of Ropivicaine for up to 48 hours after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TAP catheter with Ropivicaine</intervention_name>
    <description>Patients will receive TAP catheter with continuous infusion of Ropivicaine.</description>
    <arm_group_label>TAP catheter with continuous infusion of Ropivicaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fentanyl IV PCA and placebo TAP catheter</intervention_name>
    <description>Patients will receive placebo TAP catheter with Fentanyl IV PCA.</description>
    <arm_group_label>Fentanyl IV PCA and placebo TAP catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient is &gt;18 years of age&#xD;
&#xD;
          -  The patient has provided written informed consent and understands the explanation of&#xD;
             the protocol.&#xD;
&#xD;
          -  The patient is scheduled to have a unilateral renal transplant with a flank incision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged &lt;18.&#xD;
&#xD;
          -  Patients with a known allergy to amide local anesthetics or para-aminobenzoic acid.&#xD;
&#xD;
          -  Patients who are unable to understand the verbal analog pain scale.&#xD;
&#xD;
          -  Patients who decline participation.&#xD;
&#xD;
          -  Patients with a midline abdominal incision.&#xD;
&#xD;
          -  Combined transplants, ie. Kidney-pancreas&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ehab Farag, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>May 20, 2016</last_update_submitted>
  <last_update_submitted_qc>May 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>renal transplant</keyword>
  <keyword>flank incision</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</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/NCT01679106
org study id: 12-559
nct id: NCT01679106
lead sponsor: 
has dmc: No
Up to 174 patients undergoing renal transplantation will be randomized to one of two groups.
      Randomization will be based on computer-generated codes using random block sizes ranging from
      4 to 8.

      Group 1: TAP catheter with continuous infusion of Ropivicaine Group 2: Fentanyl IV PCA

      The TAP catheter will be removed 48 hours postoperatively. Following removal, the pain scores
      will be assessed at 60 and 72 hours postoperatively to determine any prolonged analgesic
      benefit. In addition, the presence of any pain at the incision site will be noted at the 1
      month surgical follow-up to determine any evidence of chronic pain.

      The investigators hypothesis is that unilateral kidney transplant patients with a continuous
      TAP catheter will have decreased pain scores and opioid usage compared to those receiving
      standard analgesic therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Effect of continuous TAP analgesia and pain scores
time frame: day 1
description: The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
measure: Effect of TAP analgesia and opioid requirements
time frame: Day 1
description: The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
measure: Effect of continuous TAP analgesia on pain scores
time frame: Day 2
description: The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
measure: effect of continuous TAP analgesia on pain scores
time frame: Day 3
description: The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
measure: Effect of continuous TAP analgesia on pain scores
time frame: 30 days
description: The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
measure: Effect of TAP analgesia on opioid requirements
time frame: Day 2
description: The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
measure: Effect of TAP analgesia on opioid requirements
time frame: Day 3
description: The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
measure: Effect of TAP analgesia on opioid requirements
time frame: Day 30
description: The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
arm group label: Fentanyl IV PCA and placebo TAP catheter
arm group type: Placebo Comparator
description: Patients will receive Fentanyl IV PCA and placebo TAP catheter.
arm group label: TAP catheter with continuous infusion of Ropivicaine
arm group type: Active Comparator
description: Patients will receive TAP catheter with continuous infusion of Ropivicaine for up to 48 hours after surgery.
intervention type: Other
intervention name: TAP catheter with Ropivicaine
description: Patients will receive TAP catheter with continuous infusion of Ropivicaine.
arm group label: TAP catheter with continuous infusion of Ropivicaine
intervention type: Other
intervention name: Fentanyl IV PCA and placebo TAP catheter
description: Patients will receive placebo TAP catheter with Fentanyl IV PCA.
arm group label: Fentanyl IV PCA and placebo TAP catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ehab Farag, M.D.
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fentanyl