<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/NCT02991053</url>
  </required_header>
  <id_info>
    <org_study_id>ERZINCAN UNIVERSITY 8</org_study_id>
    <nct_id>NCT02991053</nct_id>
  </id_info>
  <brief_title>Comparison of Transversus Abdominis Plane Block and Ilioinguinal / Iliohypogastric Nerve Block</brief_title>
  <official_title>Ultrasonography Guided Ilioinguinal /Iliohypogastric Block Versus Transversus Abdominis Plane Block in Intraoperative Anesthesia in Children - Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erzincan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erzincan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      the aim of this study is to compare the effects of Transversus abdominis plane block and&#xD;
      ilioinguinal / iliohypogastric block combined with sedation in pediatric surgeon on the&#xD;
      anesthesia and analgesia contributions during surgery without general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of anesthetic drug which was used</measure>
    <time_frame>2 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative visual analogue scale</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Intra-operative Anesthesia</condition>
  <arm_group>
    <arm_group_label>block and ketamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transversus Abdominis Plane block after ketamine atropine induction and continued with ketamine only in anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>block; ketamine with laryngeal mask; inhalation anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane minimum alveolar concentration and oxygen / air mixture and applied Transversus Abdominis Plane block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>block and ketamine ıh/ıl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ilioinguinal / iliohypogastric block after ketamine atropine induction and continued with ketamine only in anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ıh/ıl block; ketamine; inhalation anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane minimum alveolar concentration and oxygen / air mixture and applied Ilioinguinal / iliohypogastric block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane minimum alveolar concentration and oxygen / air mixture and Non-block, postoperative analgesia with paracetamol IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ketamine</intervention_name>
    <arm_group_label>block and ketamine</arm_group_label>
    <arm_group_label>block and ketamine ıh/ıl</arm_group_label>
    <arm_group_label>block; ketamine with laryngeal mask; inhalation anesthesia</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>ıh/ıl block; ketamine; inhalation anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American society of anesthesia score I-II&#xD;
&#xD;
          -  To undergo elective lower abdominal surgery&#xD;
&#xD;
          -  between 2-6 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with psychiatric disease&#xD;
&#xD;
          -  Patients whose weight is more than 40 kg&#xD;
&#xD;
          -  Patients with cardiac-pulmonary-neurological disease&#xD;
&#xD;
          -  Patients with bleeding disorder&#xD;
&#xD;
          -  Patients with infection or scar on the injection area&#xD;
&#xD;
          -  Patients with known allergies to local anesthetics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ilke kupeli</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erzincan University</affiliation>
  </overall_official>
  <reference>
    <citation>Newman K, Ponsky T, Kittle K, Dyk L, Throop C, Gieseker K, Sills M, Gilbert J. Appendicitis 2000: variability in practice, outcomes, and resource utilization at thirty pediatric hospitals. J Pediatr Surg. 2003 Mar;38(3):372-9; discussion 372-9. doi: 10.1053/jpsu.2003.50111.</citation>
    <PMID>12632352</PMID>
  </reference>
  <reference>
    <citation>Scott AD, Phillips A, White JB, Stow PJ. Analgesia following inguinal herniotomy or orchidopexy in children: a comparison of caudal and regional blockade. J R Coll Surg Edinb. 1989 Jun;34(3):143-5.</citation>
    <PMID>2810163</PMID>
  </reference>
  <reference>
    <citation>Markham SJ, Tomlinson J, Hain WR. Ilioinguinal nerve block in children. A comparison with caudal block for intra and postoperative analgesia. Anaesthesia. 1986 Nov;41(11):1098-103. doi: 10.1111/j.1365-2044.1986.tb12956.x.</citation>
    <PMID>3789367</PMID>
  </reference>
  <reference>
    <citation>Tanaka M, Mori N, Murakami W, Tanaka N, Oku K, Hiramatsu R, Nakagawa M, Yasumoto K. [The effect of transversus abdominis plane block for pediatric patients receiving bone graft to the alveolar cleft]. Masui. 2010 Sep;59(9):1185-9. Japanese.</citation>
    <PMID>20857679</PMID>
  </reference>
  <reference>
    <citation>Stuart-Smith K. Hemiarthroplasty performed under transversus abdominis plane block in a patient with severe cardiorespiratory disease. Anaesthesia. 2013 Apr;68(4):417-20. doi: 10.1111/anae.12108. Epub 2012 Dec 17.</citation>
    <PMID>23252578</PMID>
  </reference>
  <reference>
    <citation>Tekelioglu UY, Demirhan A, Sit M, Kurt AD, Bilgi M, Kocoglu H. Colostomy with Transversus Abdominis Plane Block. Turk J Anaesthesiol Reanim. 2015 Dec;43(6):424-6. doi: 10.5152/TJAR.2015.89410. Epub 2015 Dec 1.</citation>
    <PMID>27366540</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>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erzincan University</investigator_affiliation>
    <investigator_full_name>ILKE KUPELI</investigator_full_name>
    <investigator_title>assist. prof.</investigator_title>
  </responsible_party>
  <keyword>Intra-operative anesthesia</keyword>
  <keyword>Pediatric patient</keyword>
  <keyword>Transversus Abdominis Plane Block</keyword>
  <keyword>ilioinguinal / iliohypogastric nerve block</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02991053
org study id: ERZINCAN UNIVERSITY 8
nct id: NCT02991053
lead sponsor: 
has dmc: No
the aim of this study is to compare the effects of Transversus abdominis plane block and
      ilioinguinal / iliohypogastric block combined with sedation in pediatric surgeon on the
      anesthesia and analgesia contributions during surgery without general anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Amount of anesthetic drug which was used
time frame: 2 hour
measure: Postoperative visual analogue scale
time frame: one day
arm group label: block and ketamine
arm group type: Active Comparator
description: Transversus Abdominis Plane block after ketamine atropine induction and continued with ketamine only in anesthesia
arm group label: block; ketamine with laryngeal mask; inhalation anesthesia
arm group type: Active Comparator
description: After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane minimum alveolar concentration and oxygen / air mixture and applied Transversus Abdominis Plane block.
arm group label: block and ketamine ıh/ıl
arm group type: Active Comparator
description: Ilioinguinal / iliohypogastric block after ketamine atropine induction and continued with ketamine only in anesthesia
arm group label: ıh/ıl block; ketamine; inhalation anesthesia
arm group type: Active Comparator
description: After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane minimum alveolar concentration and oxygen / air mixture and applied Ilioinguinal / iliohypogastric block.
arm group label: control group
arm group type: Active Comparator
description: After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane minimum alveolar concentration and oxygen / air mixture and Non-block, postoperative analgesia with paracetamol IV
intervention type: Drug
intervention name: ketamine
arm group label: block and ketamine
arm group label: block and ketamine ıh/ıl
arm group label: block; ketamine with laryngeal mask; inhalation anesthesia
arm group label: control group
arm group label: ıh/ıl block; ketamine; inhalation anesthesia
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: No
last name: ilke kupeli
role: Principal Investigator
affiliation: Erzincan University
citation: Newman K, Ponsky T, Kittle K, Dyk L, Throop C, Gieseker K, Sills M, Gilbert J. Appendicitis 2000: variability in practice, outcomes, and resource utilization at thirty pediatric hospitals. J Pediatr Surg. 2003 Mar;38(3):372-9; discussion 372-9. doi: 10.1053/jpsu.2003.50111.
PMID: 12632352
citation: Scott AD, Phillips A, White JB, Stow PJ. Analgesia following inguinal herniotomy or orchidopexy in children: a comparison of caudal and regional blockade. J R Coll Surg Edinb. 1989 Jun;34(3):143-5.
PMID: 2810163
citation: Markham SJ, Tomlinson J, Hain WR. Ilioinguinal nerve block in children. A comparison with caudal block for intra and postoperative analgesia. Anaesthesia. 1986 Nov;41(11):1098-103. doi: 10.1111/j.1365-2044.1986.tb12956.x.
PMID: 3789367
citation: Tanaka M, Mori N, Murakami W, Tanaka N, Oku K, Hiramatsu R, Nakagawa M, Yasumoto K. [The effect of transversus abdominis plane block for pediatric patients receiving bone graft to the alveolar cleft]. Masui. 2010 Sep;59(9):1185-9. Japanese.
PMID: 20857679
citation: Stuart-Smith K. Hemiarthroplasty performed under transversus abdominis plane block in a patient with severe cardiorespiratory disease. Anaesthesia. 2013 Apr;68(4):417-20. doi: 10.1111/anae.12108. Epub 2012 Dec 17.
PMID: 23252578
citation: Tekelioglu UY, Demirhan A, Sit M, Kurt AD, Bilgi M, Kocoglu H. Colostomy with Transversus Abdominis Plane Block. Turk J Anaesthesiol Reanim. 2015 Dec;43(6):424-6. doi: 10.5152/TJAR.2015.89410. Epub 2015 Dec 1.
PMID: 27366540
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.
PMID: 22696610
responsible party type: Principal Investigator
investigator affiliation: Erzincan University
investigator full name: ILKE KUPELI
investigator title: assist. prof.
mesh term: Ketamine
sharing ipd: No