<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/NCT01698268</url>
  </required_header>
  <id_info>
    <org_study_id>2011-213</org_study_id>
    <nct_id>NCT01698268</nct_id>
  </id_info>
  <brief_title>Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery</brief_title>
  <acronym>TAP</acronym>
  <official_title>The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaveh Aslani, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study measures the difference in pain after hernia &amp;/or hydrocele repair based on site of&#xD;
      local anesthesia injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single-center, prospective, single blind, randomized study will enroll up to 50 subjects&#xD;
      who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health&#xD;
      System, post-operative pain management in children is managed either via oral/parenteral&#xD;
      opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local&#xD;
      anesthetics in the general area of incision), or via regional techniques (spinal, epidural,&#xD;
      or peripheral nerve blocks). We have designed this study to determine if there is improved&#xD;
      qualitative and quantitative post-operative pain control in patients receiving TAP block&#xD;
      versus intraoperative peri-incisional, surgeon administered field block. Once informed&#xD;
      consent has been given, each patient will be randomized (like flip of the coin) to either&#xD;
      Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)</measure>
    <time_frame>Admission into PACU</time_frame>
    <description>FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Hydrocele</condition>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>TAP Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local Infiltration Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAP block</intervention_name>
    <description>TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.</description>
    <arm_group_label>TAP Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Local Infiltration</intervention_name>
    <description>Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.</description>
    <arm_group_label>Local Infiltration Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children 2-8 years of age&#xD;
&#xD;
          -  Elective inguinal hernia repair, inguinal hernia repair with peritoneoscopy and/or&#xD;
             hydrocelectomy to be performed in the Center for Children's Surgery, Beaumont&#xD;
             Hospital, Royal Oak&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status classification 1 and 2 (patients&#xD;
             that have either no systemic illness, or mild systemic disease that is well&#xD;
             controlled, eg. mild asthma)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergy to study medications&#xD;
&#xD;
          -  Enrollment in concurrent research study&#xD;
&#xD;
          -  Pregnant patients*&#xD;
&#xD;
          -  Students/trainees/staff*&#xD;
&#xD;
          -  Mentally disabled/cognitively impaired*&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaveh Aslani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beaumont Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaumont Health System</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>January 18, 2017</results_first_submitted>
  <results_first_submitted_qc>March 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2017</results_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Kaveh Aslani, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This single-center, prospective, single blind, randomized study enrolled subjects who were scheduled for elective hydrocelectomy and/or hernia repair at Beaumont Hospital-Royal Oak. The first procedure was on 3/16/2012 and the last one was on 11/12/2014.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>TAP Group</title>
          <description>Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.&#xD;
TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.</description>
        </group>
        <group group_id="P2">
          <title>Local Infiltration Group</title>
          <description>Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.&#xD;
Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data not included for patients removed from study by physician</population>
      <group_list>
        <group group_id="B1">
          <title>TAP Group</title>
          <description>Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.&#xD;
TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.</description>
        </group>
        <group group_id="B2">
          <title>Local Infiltration Group</title>
          <description>Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.&#xD;
Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="47"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)</title>
        <description>FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.</description>
        <time_frame>Admission into PACU</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TAP Group</title>
            <description>Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.&#xD;
TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.</description>
          </group>
          <group group_id="O2">
            <title>Local Infiltration Group</title>
            <description>Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.&#xD;
Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.</description>
          </group>
        </group_list>
        <measure>
          <title>FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)</title>
          <description>FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>TAP Group</title>
          <description>Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.&#xD;
TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.</description>
        </group>
        <group group_id="E2">
          <title>Local Infiltration Group</title>
          <description>Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.&#xD;
Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary urgency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>skin inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Incisional pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Of the 47 treated patients, the local infiltration was administered by 8 different surgeons while the TAP block was administered by 2 different anesthesiologists.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kaveh Aslani, MD</name_or_title>
      <organization>Beaumont Health</organization>
      <phone>248-898-81905</phone>
      <email>kaslani@beaumont.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01698268
org study id: 2011-213
nct id: NCT01698268
lead sponsor: 
has dmc: Yes
Study measures the difference in pain after hernia &/or hydrocele repair based on site of
      local anesthesia injection.
This single-center, prospective, single blind, randomized study will enroll up to 50 subjects
      who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health
      System, post-operative pain management in children is managed either via oral/parenteral
      opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local
      anesthetics in the general area of incision), or via regional techniques (spinal, epidural,
      or peripheral nerve blocks). We have designed this study to determine if there is improved
      qualitative and quantitative post-operative pain control in patients receiving TAP block
      versus intraoperative peri-incisional, surgeon administered field block. Once informed
      consent has been given, each patient will be randomized (like flip of the coin) to either
      Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)
time frame: Admission into PACU
description: FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.
arm group label: TAP Group
arm group type: Experimental
description: Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.
arm group label: Local Infiltration Group
arm group type: Active Comparator
description: Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.
intervention type: Procedure
intervention name: TAP block
description: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.
arm group label: TAP Group
intervention type: Procedure
intervention name: Local Infiltration
description: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.
arm group label: Local Infiltration Group
criteria: 
gender: All
minimum age: 2 Years
maximum age: 8 Years
healthy volunteers: No
last name: Kaveh Aslani, MD
role: Principal Investigator
affiliation: Beaumont Health System
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Kaveh Aslani, MD
investigator title: Principal Investigator
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Of the 47 treated patients, the local infiltration was administered by 8 different surgeons while the TAP block was administered by 2 different anesthesiologists.
point of contact: 