<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/NCT03041948</url>
  </required_header>
  <id_info>
    <org_study_id>REB15-0434</org_study_id>
    <nct_id>NCT03041948</nct_id>
  </id_info>
  <brief_title>Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair</brief_title>
  <official_title>Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alberta Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Alberta Children's Hospital</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>
      Surgical intervention to treat a inguinal hernia is a very common pediatric surgical&#xD;
      procedure, often performed using an inguinal incision. Children who undergo hernia repair can&#xD;
      suffer from a significant degree of discomfort postoperatively. The investigators are&#xD;
      evaluating the effectiveness of an ultrasound guided caudal-epidural (CE) block to an US&#xD;
      guided ilioinguinal/iliohypogastric (IIG/IHG) nerve block in achieving post operative&#xD;
      analgesia following a hernia repair. It is hypothesized that US guided IIG/IHG nerve block&#xD;
      leads to more effective pain control post-operatively while in hospital relative to an US&#xD;
      guided CE block for inguinal hernia surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical intervention to treat a inguinal hernia is a very common pediatric surgical&#xD;
      procedure, often performed using an inguinal incision. Children who undergo hernia repair can&#xD;
      suffer from a significant degree of discomfort postoperatively. A multimodal pain management&#xD;
      approach including medications such as acetaminophen, non-steroidal anti-inflammatory drugs&#xD;
      and opioids have traditionally been used in combination with a regional anesthetic technique.&#xD;
      Regional anesthetic techniques include surgical infiltration of local anesthetic,&#xD;
      caudal-epidural (CE) block or an ilioinguinal/iliohypogastric (IIG/IHG) nerve block.&#xD;
&#xD;
      Regional anesthetic techniques such as CE and ultrasound (US) guided IIG/IHG are&#xD;
      well-established methods shown to reduce the use of intraoperative anesthetics and the need&#xD;
      post operative rescue analgesia. Traditionally, IIG/IHG nerve blocks were completed using a&#xD;
      landmark-based approach but due to unpredictable block results with failure rates over 30%&#xD;
      and potentially serious complications such as unintentional intraperitoneal injection, many&#xD;
      anesthesiologists preferred the more reliable CE technique. However, while the CE provides&#xD;
      excellent intraoperative anesthesia it provides short duration of post-operative analgesia&#xD;
      (4-6 hours) and can be associated with lower limb motor block and urinary retention. Recent&#xD;
      literature has demonstrated that an US guided IIG/IHG can be completed with smaller volume of&#xD;
      local anesthetic with a success rate of up to 100% with low risk of complications.&#xD;
      Furthermore there is evidence to suggest that it provides an increased duration of&#xD;
      postoperative analgesia for pediatric patients undergoing groin surgery. Finally, two&#xD;
      publications retrospectively reviewing complications in over 45000 regional anesthetic blocks&#xD;
      suggest that US guided peripheral nerve blocks (e.g., IIG/IHG) should be favoured over&#xD;
      neuraxial techniques such as epidural and caudal anesthetics due to the risk-benefit profile.&#xD;
      A recent meta-analysis comparing IIG/IIH block to the CE block in children notes that&#xD;
      additional comparative studies are required as previous studies comparing these two&#xD;
      techniques have many methodological limitations including small sample sizes, using blind&#xD;
      (non-US guided) regional anesthetic techniques and grouping patients undergoing various&#xD;
      surgical procedures (e.g., orchiopexy and hernia repair) despite significant differences in&#xD;
      recovery pain profiles.&#xD;
&#xD;
      The investigators are proposing to complete a prospective randomized single-blinded&#xD;
      non-inferiority study to evaluate and compare the effectiveness of an US guided CE block to&#xD;
      an US guided IIG/IHG nerve block in achieving post operative analgesia following a hernia&#xD;
      repair. Currently, a number of Pediatric Anesthesiologists at the Alberta Children's Hospital&#xD;
      do not routinely complete IIG/IIH or CE blocks under ultrasound guidance. As part of this&#xD;
      study investigators hope to provide necessary knowledge (sonoanatomy, technique) and offer&#xD;
      supervised clinical training to anesthesiologists who are interested in participating in the&#xD;
      study. While a hernia repair remains a common procedure, no studies have compared the use of&#xD;
      US guided CE to US guided IIG/IHG. The aim of this study is to establish non-inferiority in&#xD;
      post-operative pain while in hospital as assessed through the Face, Leg, Activity, Cry,&#xD;
      Consolability (FLACC) scale for the US guided IIG/IHG as compared to US guided CE following&#xD;
      hernia repair surgery. Secondary objectives will assess for group differences in need for&#xD;
      rescue analgesia in hospital, analgesia administered at home, and postoperative pain measures&#xD;
      within 24 hours post hospital discharge.&#xD;
&#xD;
      Investigators hypothesize that a US guided IIG/IHG nerve block leads to non-inferior&#xD;
      objectively measured FLACC pain scores (≤ 1 point on FLACC scale) post-operatively while in&#xD;
      hospital relative to an US guided CE block for inguinal hernia surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Anticipated">September 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</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>Post-operative pain</measure>
    <time_frame>Immediately following the procedure</time_frame>
    <description>Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>15 minutes post-operatively</time_frame>
    <description>Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>30 minutes post-operatively</time_frame>
    <description>Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>60 minutes post-operatively</time_frame>
    <description>Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>120 minutes post-operatively</time_frame>
    <description>Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>24 hours post-operatively</time_frame>
    <description>Patients will be contacted 24 hours following their surgery to complete the parents' postoperative pain measure (PPPM). The PPPM is a well-established post-operative pain assessment tool with high inter-rater reliability and construct validity that has been designed specifically for use by parents in the post-operative care of their children. The measure includes 15 items scored between 0 and 1. The questionnaire will be completed over the telephone within 24 hours of the patient's surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total ibuprofen consumption</measure>
    <time_frame>Up to 24 hours post-operatively</time_frame>
    <description>Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total acetaminophen consumption</measure>
    <time_frame>Up to 24 hours post-operatively</time_frame>
    <description>Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Hernia, Inguinal</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Caudal-epidural nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients will receive acetaminophen (15mg/kg) within one hour of induction of anesthesia. Inhalation induction of anesthesia will be performed with sevoflurane in 100% O2. A single dose of up to 2-4 mg/kg of propofol and Remifentanil 0.5-1mcg/kg will be given prior insertion of a laryngeal mask airway or endotracheal tube. Anesthesia will be maintained with Propofol and Remifentanil (2.5mcg/ml) which will be started at 300 mcg/kg/min and titrated to effect. If necessary additional boluses of Propofol (1mg/kg) and/or Remifentanil (0.5-1mcg/kg) and/or Morphine 0.05mg/kg boluses IV will be administered. Ondansetron (0.1mg/kg) and Dexamethasone (0.15mg/kg) will be given as antiemetic prophylaxis for all patients. Ketorolac 0.3mg/kg will be given to each patient. The CE group will receive an US-confirmed CE nerve block with 0.8 mL/kg of 0.2% ropivacaine (maximum 15 mL).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ilioinguinal/iliohypogastric nerve block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will receive acetaminophen (15mg/kg) within one hour of induction of anesthesia. Inhalation induction of anesthesia will be performed with sevoflurane in 100% O2. A single dose of up to 2-4 mg/kg of propofol and Remifentanil 0.5-1mcg/kg will be given prior insertion of a laryngeal mask airway or endotracheal tube. Anesthesia will be maintained with Propofol and Remifentanil (2.5mcg/ml) which will be started at 300 mcg/kg/min and titrated to effect. If necessary additional boluses of Propofol (1mg/kg) and/or Remifentanil (0.5-1mcg/kg) and/or Morphine 0.05mg/kg boluses IV will be administered. Ondansetron (0.1mg/kg) and Dexamethasone (0.15mg/kg) will be given as antiemetic prophylaxis for all patients. Ketorolac 0.3mg/kg will be given to each patient. The IIG/IHG group will receive a unilateral US guided IIG/IHG with 0.4mL/kg of ropivacaine 0.2% (max 12 mL).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ilioinguinal/iliohypogastric nerve block</intervention_name>
    <description>See arm description</description>
    <arm_group_label>ilioinguinal/iliohypogastric nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Caudal-epidural nerve block</intervention_name>
    <description>See arm description</description>
    <arm_group_label>Caudal-epidural nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>See arm description</description>
    <arm_group_label>Caudal-epidural nerve block</arm_group_label>
    <arm_group_label>ilioinguinal/iliohypogastric nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>See arm description</description>
    <arm_group_label>Caudal-epidural nerve block</arm_group_label>
    <arm_group_label>ilioinguinal/iliohypogastric nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>See arm description</description>
    <arm_group_label>Caudal-epidural nerve block</arm_group_label>
    <arm_group_label>ilioinguinal/iliohypogastric nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>See arm description</description>
    <arm_group_label>Caudal-epidural nerve block</arm_group_label>
    <arm_group_label>ilioinguinal/iliohypogastric nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>See arm description</description>
    <arm_group_label>Caudal-epidural nerve block</arm_group_label>
    <arm_group_label>ilioinguinal/iliohypogastric nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>See arm description</description>
    <arm_group_label>Caudal-epidural nerve block</arm_group_label>
    <arm_group_label>ilioinguinal/iliohypogastric nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>See arm description</description>
    <arm_group_label>Caudal-epidural nerve block</arm_group_label>
    <arm_group_label>ilioinguinal/iliohypogastric nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>See arm description</description>
    <arm_group_label>Caudal-epidural nerve block</arm_group_label>
    <arm_group_label>ilioinguinal/iliohypogastric nerve block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy children (ASA I and II) between the ages of 6 months and 4 years presenting&#xD;
             for elective hernia repair who are scheduled for day stay only.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of clinically important renal, hepatic, cardiac, or&#xD;
             neurological conditions and those with a history of allergic reactions to local&#xD;
             anesthetics, bleeding diatheses, coagulopathy, and spinal abnormality such as a sacral&#xD;
             dimple will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Alberta Children's Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B 6A8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bryce Weber, MD FRCSC</last_name>
      <phone>587-227-6652</phone>
      <email>bryce.weber@albertahealthservices.ca</email>
    </contact>
    <investigator>
      <last_name>Bryce Weber, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal University Hospital/University of Saskatchewan</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer O'Brien, PhD</last_name>
      <phone>(306) 655-6497</phone>
      <email>Jennifer.O'Brien@saskatoonhealthregion.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Verghese ST, Hannallah RS. Acute pain management in children. J Pain Res. 2010 Jul 15;3:105-23. doi: 10.2147/jpr.s4554.</citation>
    <PMID>21197314</PMID>
  </reference>
  <reference>
    <citation>Koo BN, Hong JY, Song HT, Kim JM, Kil HK. Ultrasonography reveals a high prevalence of lower spinal dysraphism in children with urogenital anomalies. Acta Anaesthesiol Scand. 2012 May;56(5):624-8. doi: 10.1111/j.1399-6576.2011.02612.x. Epub 2012 Feb 16.</citation>
    <PMID>22338610</PMID>
  </reference>
  <reference>
    <citation>Weintraud M, Marhofer P, Bosenberg A, Kapral S, Willschke H, Felfernig M, Kettner S. Ilioinguinal/iliohypogastric blocks in children: where do we administer the local anesthetic without direct visualization? Anesth Analg. 2008 Jan;106(1):89-93, table of contents. doi: 10.1213/01.ane.0000287679.48530.5f.</citation>
    <PMID>18165559</PMID>
  </reference>
  <reference>
    <citation>Jagannathan N, Sohn L, Sawardekar A, Ambrosy A, Hagerty J, Chin A, Barsness K, Suresh S. Unilateral groin surgery in children: will the addition of an ultrasound-guided ilioinguinal nerve block enhance the duration of analgesia of a single-shot caudal block? Paediatr Anaesth. 2009 Sep;19(9):892-8. doi: 10.1111/j.1460-9592.2009.03092.x. Epub 2009 Jul 13.</citation>
    <PMID>19627532</PMID>
  </reference>
  <reference>
    <citation>Abdellatif AA. Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks versus caudal block for postoperative analgesia in children undergoing unilateral groin surgery. Saudi J Anaesth. 2012 Oct-Dec;6(4):367-72. doi: 10.4103/1658-354X.105868.</citation>
    <PMID>23493806</PMID>
  </reference>
  <reference>
    <citation>Ecoffey C, Lacroix F, Giaufre E, Orliaguet G, Courreges P; Association des Anesthesistes Reanimateurs Pediatriques d'Expression Francaise (ADARPEF). Epidemiology and morbidity of regional anesthesia in children: a follow-up one-year prospective survey of the French-Language Society of Paediatric Anaesthesiologists (ADARPEF). Paediatr Anaesth. 2010 Dec;20(12):1061-9. doi: 10.1111/j.1460-9592.2010.03448.x.</citation>
    <PMID>21199114</PMID>
  </reference>
  <reference>
    <citation>Polaner DM, Taenzer AH, Walker BJ, Bosenberg A, Krane EJ, Suresh S, Wolf C, Martin LD. Pediatric Regional Anesthesia Network (PRAN): a multi-institutional study of the use and incidence of complications of pediatric regional anesthesia. Anesth Analg. 2012 Dec;115(6):1353-64. doi: 10.1213/ANE.0b013e31825d9f4b. Epub 2012 Jun 13.</citation>
    <PMID>22696610</PMID>
  </reference>
  <reference>
    <citation>Shanthanna H, Singh B, Guyatt G. A systematic review and meta-analysis of caudal block as compared to noncaudal regional techniques for inguinal surgeries in children. Biomed Res Int. 2014;2014:890626. doi: 10.1155/2014/890626. Epub 2014 Aug 5.</citation>
    <PMID>25162033</PMID>
  </reference>
  <reference>
    <citation>von Baeyer CL, Spagrud LJ. Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years. Pain. 2007 Jan;127(1-2):140-50. doi: 10.1016/j.pain.2006.08.014. Epub 2006 Sep 25.</citation>
    <PMID>16996689</PMID>
  </reference>
  <reference>
    <citation>Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.</citation>
    <PMID>9220806</PMID>
  </reference>
  <reference>
    <citation>Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2.</citation>
    <PMID>14527704</PMID>
  </reference>
  <reference>
    <citation>Cole J, Shepherd M, Young P. Intranasal fentanyl in 1-3-year-olds: a prospective study of the effectiveness of intranasal fentanyl as acute analgesia. Emerg Med Australas. 2009 Oct;21(5):395-400. doi: 10.1111/j.1742-6723.2009.01216.x.</citation>
    <PMID>19840089</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>November 9, 2017</last_update_submitted>
  <last_update_submitted_qc>November 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alberta Children's Hospital</investigator_affiliation>
    <investigator_full_name>Bryce Weber</investigator_full_name>
    <investigator_title>Pediatric Urologist</investigator_title>
  </responsible_party>
  <keyword>Inguinal hernia</keyword>
  <keyword>Caudal nerve block</keyword>
  <keyword>Ilioinguinal nerve block</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Ondansetron</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03041948
org study id: REB15-0434
nct id: NCT03041948
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgical intervention to treat a inguinal hernia is a very common pediatric surgical
      procedure, often performed using an inguinal incision. Children who undergo hernia repair can
      suffer from a significant degree of discomfort postoperatively. The investigators are
      evaluating the effectiveness of an ultrasound guided caudal-epidural (CE) block to an US
      guided ilioinguinal/iliohypogastric (IIG/IHG) nerve block in achieving post operative
      analgesia following a hernia repair. It is hypothesized that US guided IIG/IHG nerve block
      leads to more effective pain control post-operatively while in hospital relative to an US
      guided CE block for inguinal hernia surgery.
Surgical intervention to treat a inguinal hernia is a very common pediatric surgical
      procedure, often performed using an inguinal incision. Children who undergo hernia repair can
      suffer from a significant degree of discomfort postoperatively. A multimodal pain management
      approach including medications such as acetaminophen, non-steroidal anti-inflammatory drugs
      and opioids have traditionally been used in combination with a regional anesthetic technique.
      Regional anesthetic techniques include surgical infiltration of local anesthetic,
      caudal-epidural (CE) block or an ilioinguinal/iliohypogastric (IIG/IHG) nerve block.

      Regional anesthetic techniques such as CE and ultrasound (US) guided IIG/IHG are
      well-established methods shown to reduce the use of intraoperative anesthetics and the need
      post operative rescue analgesia. Traditionally, IIG/IHG nerve blocks were completed using a
      landmark-based approach but due to unpredictable block results with failure rates over 30%
      and potentially serious complications such as unintentional intraperitoneal injection, many
      anesthesiologists preferred the more reliable CE technique. However, while the CE provides
      excellent intraoperative anesthesia it provides short duration of post-operative analgesia
      (4-6 hours) and can be associated with lower limb motor block and urinary retention. Recent
      literature has demonstrated that an US guided IIG/IHG can be completed with smaller volume of
      local anesthetic with a success rate of up to 100% with low risk of complications.
      Furthermore there is evidence to suggest that it provides an increased duration of
      postoperative analgesia for pediatric patients undergoing groin surgery. Finally, two
      publications retrospectively reviewing complications in over 45000 regional anesthetic blocks
      suggest that US guided peripheral nerve blocks (e.g., IIG/IHG) should be favoured over
      neuraxial techniques such as epidural and caudal anesthetics due to the risk-benefit profile.
      A recent meta-analysis comparing IIG/IIH block to the CE block in children notes that
      additional comparative studies are required as previous studies comparing these two
      techniques have many methodological limitations including small sample sizes, using blind
      (non-US guided) regional anesthetic techniques and grouping patients undergoing various
      surgical procedures (e.g., orchiopexy and hernia repair) despite significant differences in
      recovery pain profiles.

      The investigators are proposing to complete a prospective randomized single-blinded
      non-inferiority study to evaluate and compare the effectiveness of an US guided CE block to
      an US guided IIG/IHG nerve block in achieving post operative analgesia following a hernia
      repair. Currently, a number of Pediatric Anesthesiologists at the Alberta Children's Hospital
      do not routinely complete IIG/IIH or CE blocks under ultrasound guidance. As part of this
      study investigators hope to provide necessary knowledge (sonoanatomy, technique) and offer
      supervised clinical training to anesthesiologists who are interested in participating in the
      study. While a hernia repair remains a common procedure, no studies have compared the use of
      US guided CE to US guided IIG/IHG. The aim of this study is to establish non-inferiority in
      post-operative pain while in hospital as assessed through the Face, Leg, Activity, Cry,
      Consolability (FLACC) scale for the US guided IIG/IHG as compared to US guided CE following
      hernia repair surgery. Secondary objectives will assess for group differences in need for
      rescue analgesia in hospital, analgesia administered at home, and postoperative pain measures
      within 24 hours post hospital discharge.

      Investigators hypothesize that a US guided IIG/IHG nerve block leads to non-inferior
      objectively measured FLACC pain scores (≤ 1 point on FLACC scale) post-operatively while in
      hospital relative to an US guided CE block for inguinal hernia surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Post-operative pain
time frame: Immediately following the procedure
description: Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).
measure: Post-operative pain
time frame: 15 minutes post-operatively
description: Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).
measure: Post-operative pain
time frame: 30 minutes post-operatively
description: Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).
measure: Post-operative pain
time frame: 60 minutes post-operatively
description: Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).
measure: Post-operative pain
time frame: 120 minutes post-operatively
description: Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).
measure: Post-operative pain
time frame: 24 hours post-operatively
description: Patients will be contacted 24 hours following their surgery to complete the parents' postoperative pain measure (PPPM). The PPPM is a well-established post-operative pain assessment tool with high inter-rater reliability and construct validity that has been designed specifically for use by parents in the post-operative care of their children. The measure includes 15 items scored between 0 and 1. The questionnaire will be completed over the telephone within 24 hours of the patient's surgery.
measure: Total ibuprofen consumption
time frame: Up to 24 hours post-operatively
description: Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up
measure: Total acetaminophen consumption
time frame: Up to 24 hours post-operatively
description: Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up
arm group label: Caudal-epidural nerve block
arm group type: Active Comparator
description: All patients will receive acetaminophen (15mg/kg) within one hour of induction of anesthesia. Inhalation induction of anesthesia will be performed with sevoflurane in 100% O2. A single dose of up to 2-4 mg/kg of propofol and Remifentanil 0.5-1mcg/kg will be given prior insertion of a laryngeal mask airway or endotracheal tube. Anesthesia will be maintained with Propofol and Remifentanil (2.5mcg/ml) which will be started at 300 mcg/kg/min and titrated to effect. If necessary additional boluses of Propofol (1mg/kg) and/or Remifentanil (0.5-1mcg/kg) and/or Morphine 0.05mg/kg boluses IV will be administered. Ondansetron (0.1mg/kg) and Dexamethasone (0.15mg/kg) will be given as antiemetic prophylaxis for all patients. Ketorolac 0.3mg/kg will be given to each patient. The CE group will receive an US-confirmed CE nerve block with 0.8 mL/kg of 0.2% ropivacaine (maximum 15 mL).
arm group label: ilioinguinal/iliohypogastric nerve block
arm group type: Experimental
description: All patients will receive acetaminophen (15mg/kg) within one hour of induction of anesthesia. Inhalation induction of anesthesia will be performed with sevoflurane in 100% O2. A single dose of up to 2-4 mg/kg of propofol and Remifentanil 0.5-1mcg/kg will be given prior insertion of a laryngeal mask airway or endotracheal tube. Anesthesia will be maintained with Propofol and Remifentanil (2.5mcg/ml) which will be started at 300 mcg/kg/min and titrated to effect. If necessary additional boluses of Propofol (1mg/kg) and/or Remifentanil (0.5-1mcg/kg) and/or Morphine 0.05mg/kg boluses IV will be administered. Ondansetron (0.1mg/kg) and Dexamethasone (0.15mg/kg) will be given as antiemetic prophylaxis for all patients. Ketorolac 0.3mg/kg will be given to each patient. The IIG/IHG group will receive a unilateral US guided IIG/IHG with 0.4mL/kg of ropivacaine 0.2% (max 12 mL).
intervention type: Procedure
intervention name: Ilioinguinal/iliohypogastric nerve block
description: See arm description
arm group label: ilioinguinal/iliohypogastric nerve block
intervention type: Procedure
intervention name: Caudal-epidural nerve block
description: See arm description
arm group label: Caudal-epidural nerve block
intervention type: Drug
intervention name: Acetaminophen
description: See arm description
arm group label: Caudal-epidural nerve block
arm group label: ilioinguinal/iliohypogastric nerve block
intervention type: Drug
intervention name: Sevoflurane
description: See arm description
arm group label: Caudal-epidural nerve block
arm group label: ilioinguinal/iliohypogastric nerve block
intervention type: Drug
intervention name: Remifentanil
description: See arm description
arm group label: Caudal-epidural nerve block
arm group label: ilioinguinal/iliohypogastric nerve block
intervention type: Drug
intervention name: Propofol
description: See arm description
arm group label: Caudal-epidural nerve block
arm group label: ilioinguinal/iliohypogastric nerve block
intervention type: Drug
intervention name: Morphine
description: See arm description
arm group label: Caudal-epidural nerve block
arm group label: ilioinguinal/iliohypogastric nerve block
intervention type: Drug
intervention name: Ondansetron
description: See arm description
arm group label: Caudal-epidural nerve block
arm group label: ilioinguinal/iliohypogastric nerve block
intervention type: Drug
intervention name: Dexamethasone
description: See arm description
arm group label: Caudal-epidural nerve block
arm group label: ilioinguinal/iliohypogastric nerve block
intervention type: Drug
intervention name: Ketorolac
description: See arm description
arm group label: Caudal-epidural nerve block
arm group label: ilioinguinal/iliohypogastric nerve block
criteria: 
gender: All
minimum age: 6 Months
maximum age: 4 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Canada
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PMID: 22338610
citation: Weintraud M, Marhofer P, Bosenberg A, Kapral S, Willschke H, Felfernig M, Kettner S. Ilioinguinal/iliohypogastric blocks in children: where do we administer the local anesthetic without direct visualization? Anesth Analg. 2008 Jan;106(1):89-93, table of contents. doi: 10.1213/01.ane.0000287679.48530.5f.
PMID: 18165559
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PMID: 19627532
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PMID: 23493806
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PMID: 21199114
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PMID: 22696610
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PMID: 25162033
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PMID: 19840089
responsible party type: Principal Investigator
investigator affiliation: Alberta Children's Hospital
investigator full name: Bryce Weber
investigator title: Pediatric Urologist
mesh term: Hernia
mesh term: Pain, Postoperative
mesh term: Hernia, Inguinal
mesh term: Acetaminophen
mesh term: Dexamethasone
mesh term: Ketorolac
mesh term: Morphine
mesh term: Remifentanil
mesh term: Ondansetron
mesh term: Propofol
mesh term: Sevoflurane
sharing ipd: Undecided