<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/NCT01662401</url>
  </required_header>
  <id_info>
    <org_study_id>CMH IRB 2008-13399</org_study_id>
    <nct_id>NCT01662401</nct_id>
  </id_info>
  <brief_title>Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Peripheral Nerve Block Versus Local Anesthetic</brief_title>
  <official_title>Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Comparison of Peripheral Nerve Blocks to Local Anesthetic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ann &amp; Robert H Lurie Children's Hospital of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in&#xD;
      the postoperative period. As a routine part of the procedure, surgeons inject local&#xD;
      anesthetic where the laparoscopic ports are placed. This provides some pain relief, but most&#xD;
      children will still require additional pain medications after surgery. The purpose of the&#xD;
      study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal&#xD;
      nerve) will give better pain relief, decreasing pain medication requirements and increasing&#xD;
      comfort during the postoperative period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A study investigator who is not involved in the immediate care of the patient will use a&#xD;
      computer generated randomized table as to whether a child undergoing laparoscopic&#xD;
      appendectomy will receive local anesthetic infiltration to the laparoscopic port placement&#xD;
      sites by the surgeon, or peripheral nerve blocks by the anesthesiologist. All subjects will&#xD;
      receive a dose of fentanyl at 2 mcg/kg with a maximum dose of 100 mcg. If the subject is to&#xD;
      get peripheral nerve blocks, the anesthesiologist will administer bilateral rectus sheath and&#xD;
      ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia.&#xD;
      The local anesthetic used will be 0.25% bupivacaine without epinephrine for both local&#xD;
      infiltration and peripheral nerve blocks. It has been shown that a dose of 0.075 ml/kg is the&#xD;
      minimum amount of local anesthetic needed for a successful block. This will be the dose for&#xD;
      each block with a maximum of 3 ml for rectus sheath blocks, and 4 ml for ilioinguinal blocks&#xD;
      adding up to a total maximum dose of 14 ml of 0.25% bupivacaine. The infiltration of port&#xD;
      sites by surgeons will also be limited to a total of 14 ml. If a subject does not have&#xD;
      adequate analgesia in the post anesthesia care unit (PACU), they may receive morphine 0.05&#xD;
      mg/kg (max 2 mg) per dose; some may receive a dose of ketorolac 0.5 mg/kg (max 30 mg) per&#xD;
      surgeon preference. A blinded observer will observe the subject for pain in the PACU using a&#xD;
      validated pain scale, Faces Pain Scale - Revised (FPS-R). The need for additional pain&#xD;
      medications will be noted by an observer in the PACU and followed for the first 24 hours&#xD;
      postoperatively. All data will be entered in an Excel spreadsheet and the number of doses of&#xD;
      rescue analgesics used will be used as the parameter to judge the efficacy of the peripheral&#xD;
      nerve blocks versus local anesthetic infiltration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2008</start_date>
  <primary_completion_date type="Actual">January 2010</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Laparoscopic appendectomy infiltration that reduces postoperative pain</measure>
    <time_frame>Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours</time_frame>
    <description>Compare postoperative analgesic requirements during the first 48 hours in children undergoing ultrasound-guided (US) rectus sheath and ilioinguinal/iliohypogastric nerve blocks compared with those receiving traditional infiltration of local anesthetic at port sites by the surgeons for laparoscopic appendectomies.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Peripheral Nerve Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia administered to subject</description>
  </arm_group>
  <arm_group>
    <arm_group_label>local anesthetic infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>local anesthetic infiltration will be administered after induction of general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 3 ml for rectus sheath blocks and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml.</description>
    <arm_group_label>Peripheral Nerve Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 14 ml.</description>
    <arm_group_label>local anesthetic infiltration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children scheduled for laparoscopic appendectomy between the ages of 6 and 18&#xD;
&#xD;
          -  Written informed consent from parent of guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sensitivities to local anesthetics&#xD;
&#xD;
          -  Significant renal, liver, or cardiac disease&#xD;
&#xD;
          -  Appendectomy requiring an open procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ann &amp; Robert H Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ferguson S, Thomas V, Lewis I. The rectus sheath block in paediatric anaesthesia: new indications for an old technique? Paediatr Anaesth. 1996;6(6):463-6. doi: 10.1046/j.1460-9592.1996.d01-24.x.</citation>
    <PMID>8936544</PMID>
  </reference>
  <reference>
    <citation>Willschke H, Bosenberg A, Marhofer P, Johnston S, Kettner S, Eichenberger U, Wanzel O, Kapral S. Ultrasonographic-guided ilioinguinal/iliohypogastric nerve block in pediatric anesthesia: what is the optimal volume? Anesth Analg. 2006 Jun;102(6):1680-4. doi: 10.1213/01.ane.0000217196.34354.5a.</citation>
    <PMID>16717308</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>June 28, 2013</last_update_submitted>
  <last_update_submitted_qc>June 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 2, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>children</keyword>
  <keyword>laparoscopic appendectomy</keyword>
  <keyword>iliohypogastric nerve block</keyword>
  <keyword>rectus sheath nerve block</keyword>
  <keyword>ilioinguinal nerve block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <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/NCT01662401
org study id: CMH IRB 2008-13399
nct id: NCT01662401
lead sponsor: 
has dmc: Yes
After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in
      the postoperative period. As a routine part of the procedure, surgeons inject local
      anesthetic where the laparoscopic ports are placed. This provides some pain relief, but most
      children will still require additional pain medications after surgery. The purpose of the
      study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal
      nerve) will give better pain relief, decreasing pain medication requirements and increasing
      comfort during the postoperative period.
A study investigator who is not involved in the immediate care of the patient will use a
      computer generated randomized table as to whether a child undergoing laparoscopic
      appendectomy will receive local anesthetic infiltration to the laparoscopic port placement
      sites by the surgeon, or peripheral nerve blocks by the anesthesiologist. All subjects will
      receive a dose of fentanyl at 2 mcg/kg with a maximum dose of 100 mcg. If the subject is to
      get peripheral nerve blocks, the anesthesiologist will administer bilateral rectus sheath and
      ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia.
      The local anesthetic used will be 0.25% bupivacaine without epinephrine for both local
      infiltration and peripheral nerve blocks. It has been shown that a dose of 0.075 ml/kg is the
      minimum amount of local anesthetic needed for a successful block. This will be the dose for
      each block with a maximum of 3 ml for rectus sheath blocks, and 4 ml for ilioinguinal blocks
      adding up to a total maximum dose of 14 ml of 0.25% bupivacaine. The infiltration of port
      sites by surgeons will also be limited to a total of 14 ml. If a subject does not have
      adequate analgesia in the post anesthesia care unit (PACU), they may receive morphine 0.05
      mg/kg (max 2 mg) per dose; some may receive a dose of ketorolac 0.5 mg/kg (max 30 mg) per
      surgeon preference. A blinded observer will observe the subject for pain in the PACU using a
      validated pain scale, Faces Pain Scale - Revised (FPS-R). The need for additional pain
      medications will be noted by an observer in the PACU and followed for the first 24 hours
      postoperatively. All data will be entered in an Excel spreadsheet and the number of doses of
      rescue analgesics used will be used as the parameter to judge the efficacy of the peripheral
      nerve blocks versus local anesthetic infiltration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Laparoscopic appendectomy infiltration that reduces postoperative pain
time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
description: Compare postoperative analgesic requirements during the first 48 hours in children undergoing ultrasound-guided (US) rectus sheath and ilioinguinal/iliohypogastric nerve blocks compared with those receiving traditional infiltration of local anesthetic at port sites by the surgeons for laparoscopic appendectomies.
arm group label: Peripheral Nerve Block
arm group type: Experimental
description: bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia administered to subject
arm group label: local anesthetic infiltration
arm group type: Experimental
description: local anesthetic infiltration will be administered after induction of general anesthesia
intervention type: Drug
intervention name: Bupivacaine
description: The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 3 ml for rectus sheath blocks and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml.
arm group label: Peripheral Nerve Block
intervention type: Drug
intervention name: Bupivacaine
description: The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 14 ml.
arm group label: local anesthetic infiltration
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: United States
citation: Ferguson S, Thomas V, Lewis I. The rectus sheath block in paediatric anaesthesia: new indications for an old technique? Paediatr Anaesth. 1996;6(6):463-6. doi: 10.1046/j.1460-9592.1996.d01-24.x.
PMID: 8936544
citation: Willschke H, Bosenberg A, Marhofer P, Johnston S, Kettner S, Eichenberger U, Wanzel O, Kapral S. Ultrasonographic-guided ilioinguinal/iliohypogastric nerve block in pediatric anesthesia: what is the optimal volume? Anesth Analg. 2006 Jun;102(6):1680-4. doi: 10.1213/01.ane.0000217196.34354.5a.
PMID: 16717308
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Bupivacaine