<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/NCT03005808</url>
  </required_header>
  <id_info>
    <org_study_id>HOSPITALIAS1</org_study_id>
    <nct_id>NCT03005808</nct_id>
  </id_info>
  <brief_title>Choose the Best Concentration of Ropivacaine on TAP Block for Open Appendectomy in Children</brief_title>
  <official_title>Choose Between Two Different Concentration of Ropivacaine on TAP Block for Children Submitted of Open Appendectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Infantil Albert Sabin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fortaleza University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Infantil Albert Sabin</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall&#xD;
      and the parietal peritoneum. The TAP block could advange the postoperative pain of&#xD;
      Appendectomy in children. The world literature doesn´t focus the best Ropivacaine´s&#xD;
      concentration to improve postoperative pain in Appendectomy in children. We propose a&#xD;
      randomized trial that compares 3 groups children submitted Appendectomy in children between 6&#xD;
      and 16 years. The control group has received no blockade, the other two groups have received&#xD;
      TAP blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall&#xD;
      and the parietal peritoneum. The meta-analyzes in adults demonstrate improved of&#xD;
      postoperative pain and analgesic´s consumption. There are few studies on TAP block in open&#xD;
      appendectomies and laparoscopic in pediatrics, they show good results. There is a consensus&#xD;
      of the best anesthetic volume for good infiltration of the TAP block, but there are still&#xD;
      doubts in the literature about the best concentration of local anesthetics of long duration.&#xD;
      The main objective of this prospective, randomly distributed and double-blind clinical trial&#xD;
      is to evaluate two concentrations of 0.25% and 0.5% ropivacaine with a volume of 0.4 ml / kg&#xD;
      in pain control and the analgesic consumption through 24 hours observation in open&#xD;
      Appendectomy in children between 6 and 16 years. 3 groups were being compared: the control&#xD;
      group has received no blockade, the other two groups have received TAP blocks if ropivacaine&#xD;
      0,25% and 0,5% 0.4ml/kg. All pacients patients received the same protocols (anesthesia and&#xD;
      analgesia). The provided analgesia was dipyrone every 6 hours and ketoprofen every 8 hours,&#xD;
      and rescue analgesia was tramadol every 4hours if it were required. The FACE pain scale was&#xD;
      used to evaluate the postoperative pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 4</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduce the pain intensity using the Face Pain Scale</measure>
    <time_frame>24 hour after surgery</time_frame>
    <description>Subjected to the same general anesthesia protocol and postoperative analgesia. The TAP0.25 and TAP0.5 groups received TAP block with ropivacaine 0.25% or 0.5% 0.4ml/kg, the control group didn´t receive block. The evaluation times were: 1 hour, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours after surgery. The time elapsed was recorded, from the end of the surgery to the first use of tramadol. The parents and the patients themselves were instructed to request analgesic at any time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduce the opioid consumption through 24 hours postoperative observation</measure>
    <time_frame>24 hour after surgery</time_frame>
    <description>Subjected to the same general anesthesia protocol and analgesia. The TAP0.25 and TAP0.5 groups received TAP block with ropivacaine 0.25% or 0.5% 0.4ml/kg, the control group didn´t receive block. All patients received dipyrone and ketoprofen, the rescue analgesic used was tramadol 1.5mg / kg (maximum dose of 100mg) up to 4 / 4h when Face´s Scales reached 5 points.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Appendicitis</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All patients had the same protocol of anesthesia and analgesia. The control group didn´t received block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAP 0.25 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The TAP 0.25 group received TAP block with ropivacaine 0.25% 0.4ml/kg. All patients had the same protocol of anesthesia and analgesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAP 0.5 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The TAP 0.5 group received TAP block with ropivacaine 0.5% 0.4ml/kg. All patients had the same protocol of anesthesia and analgesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Surgery for appendicitis</description>
    <arm_group_label>TAP 0.25 group</arm_group_label>
    <arm_group_label>TAP 0.5 group</arm_group_label>
    <other_name>Appendectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children between 6 and 16 years who were previously healthy submitted to appendectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal&#xD;
             of parents, caregivers and patients to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Infantil Albert Sabin</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceara</state>
        <zip>60410794</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Abu Elyazed MM, Mostafa SF, Abdullah MA, Eid GM. The effect of ultrasound-guided transversus abdominis plane (TAP) block on postoperative analgesia and neuroendocrine stress response in pediatric patients undergoing elective open inguinal hernia repair. Paediatr Anaesth. 2016 Dec;26(12):1165-1171. doi: 10.1111/pan.12999. Epub 2016 Oct 12.</citation>
    <PMID>27731956</PMID>
  </reference>
  <reference>
    <citation>Carney J, Finnerty O, Rauf J, Curley G, McDonnell JG, Laffey JG. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial. Anesth Analg. 2010 Oct;111(4):998-1003. doi: 10.1213/ANE.0b013e3181ee7bba. Epub 2010 Aug 27.</citation>
    <PMID>20802056</PMID>
  </reference>
  <reference>
    <citation>Lapmahapaisan S, Tantemsapya N, Aroonpruksakul N, Maisat W, Suraseranivongse S. Efficacy of surgical transversus abdominis plane block for postoperative pain relief following abdominal surgery in pediatric patients. Paediatr Anaesth. 2015 Jun;25(6):614-20. doi: 10.1111/pan.12607. Epub 2015 Jan 9.</citation>
    <PMID>25571981</PMID>
  </reference>
  <reference>
    <citation>Reinoso-Barbero F, Poblacion G, Builes LM, Castro LE, Lahoz AI. Successful ultrasound guidance for transversus abdominis plane blocks improves postoperative analgesia after open appendicectomy in children. Eur J Anaesthesiol. 2012 Aug;29(8):402-4. doi: 10.1097/EJA.0b013e328353570e. No abstract available.</citation>
    <PMID>22488336</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Infantil Albert Sabin</investigator_affiliation>
    <investigator_full_name>washington aspilicueta pinto filho</investigator_full_name>
    <investigator_title>medical Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>appendectomy, pediatrics, nerve block, abdominal wall</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</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/NCT03005808
org study id: HOSPITALIAS1
nct id: NCT03005808
lead sponsor: 
collaborator: 
has dmc: Yes
Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall
      and the parietal peritoneum. The TAP block could advange the postoperative pain of
      Appendectomy in children. The world literature doesn´t focus the best Ropivacaine´s
      concentration to improve postoperative pain in Appendectomy in children. We propose a
      randomized trial that compares 3 groups children submitted Appendectomy in children between 6
      and 16 years. The control group has received no blockade, the other two groups have received
      TAP blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg.
Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall
      and the parietal peritoneum. The meta-analyzes in adults demonstrate improved of
      postoperative pain and analgesic´s consumption. There are few studies on TAP block in open
      appendectomies and laparoscopic in pediatrics, they show good results. There is a consensus
      of the best anesthetic volume for good infiltration of the TAP block, but there are still
      doubts in the literature about the best concentration of local anesthetics of long duration.
      The main objective of this prospective, randomly distributed and double-blind clinical trial
      is to evaluate two concentrations of 0.25% and 0.5% ropivacaine with a volume of 0.4 ml / kg
      in pain control and the analgesic consumption through 24 hours observation in open
      Appendectomy in children between 6 and 16 years. 3 groups were being compared: the control
      group has received no blockade, the other two groups have received TAP blocks if ropivacaine
      0,25% and 0,5% 0.4ml/kg. All pacients patients received the same protocols (anesthesia and
      analgesia). The provided analgesia was dipyrone every 6 hours and ketoprofen every 8 hours,
      and rescue analgesia was tramadol every 4hours if it were required. The FACE pain scale was
      used to evaluate the postoperative pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Reduce the pain intensity using the Face Pain Scale
time frame: 24 hour after surgery
description: Subjected to the same general anesthesia protocol and postoperative analgesia. The TAP0.25 and TAP0.5 groups received TAP block with ropivacaine 0.25% or 0.5% 0.4ml/kg, the control group didn´t receive block. The evaluation times were: 1 hour, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours after surgery. The time elapsed was recorded, from the end of the surgery to the first use of tramadol. The parents and the patients themselves were instructed to request analgesic at any time.
measure: Reduce the opioid consumption through 24 hours postoperative observation
time frame: 24 hour after surgery
description: Subjected to the same general anesthesia protocol and analgesia. The TAP0.25 and TAP0.5 groups received TAP block with ropivacaine 0.25% or 0.5% 0.4ml/kg, the control group didn´t receive block. All patients received dipyrone and ketoprofen, the rescue analgesic used was tramadol 1.5mg / kg (maximum dose of 100mg) up to 4 / 4h when Face´s Scales reached 5 points.
arm group label: control group
arm group type: No Intervention
description: All patients had the same protocol of anesthesia and analgesia. The control group didn´t received block.
arm group label: TAP 0.25 group
arm group type: Experimental
description: The TAP 0.25 group received TAP block with ropivacaine 0.25% 0.4ml/kg. All patients had the same protocol of anesthesia and analgesia.
arm group label: TAP 0.5 group
arm group type: Experimental
description: The TAP 0.5 group received TAP block with ropivacaine 0.5% 0.4ml/kg. All patients had the same protocol of anesthesia and analgesia.
intervention type: Drug
intervention name: Ropivacaine
description: Surgery for appendicitis
arm group label: TAP 0.25 group
arm group label: TAP 0.5 group
other name: Appendectomy
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
citation: Abu Elyazed MM, Mostafa SF, Abdullah MA, Eid GM. The effect of ultrasound-guided transversus abdominis plane (TAP) block on postoperative analgesia and neuroendocrine stress response in pediatric patients undergoing elective open inguinal hernia repair. Paediatr Anaesth. 2016 Dec;26(12):1165-1171. doi: 10.1111/pan.12999. Epub 2016 Oct 12.
PMID: 27731956
citation: Carney J, Finnerty O, Rauf J, Curley G, McDonnell JG, Laffey JG. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial. Anesth Analg. 2010 Oct;111(4):998-1003. doi: 10.1213/ANE.0b013e3181ee7bba. Epub 2010 Aug 27.
PMID: 20802056
citation: Lapmahapaisan S, Tantemsapya N, Aroonpruksakul N, Maisat W, Suraseranivongse S. Efficacy of surgical transversus abdominis plane block for postoperative pain relief following abdominal surgery in pediatric patients. Paediatr Anaesth. 2015 Jun;25(6):614-20. doi: 10.1111/pan.12607. Epub 2015 Jan 9.
PMID: 25571981
citation: Reinoso-Barbero F, Poblacion G, Builes LM, Castro LE, Lahoz AI. Successful ultrasound guidance for transversus abdominis plane blocks improves postoperative analgesia after open appendicectomy in children. Eur J Anaesthesiol. 2012 Aug;29(8):402-4. doi: 10.1097/EJA.0b013e328353570e. No abstract available.
PMID: 22488336
responsible party type: Principal Investigator
investigator affiliation: Hospital Infantil Albert Sabin
investigator full name: washington aspilicueta pinto filho
investigator title: medical Anesthesiologist
mesh term: Appendicitis
mesh term: Pain, Postoperative
mesh term: Ropivacaine
sharing ipd: No