<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/NCT04452656</url>
  </required_header>
  <id_info>
    <org_study_id>N159-2020</org_study_id>
    <nct_id>NCT04452656</nct_id>
  </id_info>
  <brief_title>Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block in Pediatric.</brief_title>
  <official_title>Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Cardiac Surgeries. a Randomized Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This randomized, double-blinded, study aims to compare the efficacy of analgesia and any side&#xD;
      effects of U/S guided bilateral Erector SpinaePlane block versus non-block t paediatric&#xD;
      patients undergoing corrective cardiac surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our study will be designed to estimate and compare the analgesic effect of single&#xD;
      shotbilatral erector spinae plane block in pediatric patients undergoing corrective cardiac&#xD;
      surgeries versus non-block as the control group. Our primary outcome will be the total dose&#xD;
      of intraoperative fentanyl boluses.&#xD;
&#xD;
      Randomization will be achieved by using an online random number generator. Patient codes will&#xD;
      be placed into sequentially numbered sealed opaque envelopes by a research assistant who is&#xD;
      not involved in the study. A medical personnel not involved in patient management will be&#xD;
      responsible for opening the envelope and give the instructions contained within each envelope&#xD;
      to the anesthesiologist who is expert in doing the ESP block in patients included within the&#xD;
      block group. The anesthesia team who managed the patients intraoperatively did not share in&#xD;
      recording data for the research. However, another physcian will be responsible for recording&#xD;
      the intraoperative data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">August 15, 2021</completion_date>
  <primary_completion_date type="Actual">August 5, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the Erector spinae plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The total dose of intraoperative fentanyl boluses in microgram.</measure>
    <time_frame>3 months</time_frame>
    <description>The total dose of intraoperative fentanyl boluses in microgram</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain assessment at postoperatively by FLACC score</measure>
    <time_frame>3 months</time_frame>
    <description>Pain assessment postoperatively by FLACC score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total consumption of morphine during the first 24 hours postoperatively.</measure>
    <time_frame>3 monts</time_frame>
    <description>Total consumption of morphine during the first 24 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>extubation time</measure>
    <time_frame>3 months</time_frame>
    <description>time from finishing skin incision suturing and cessation of anesthesia to successful removal of endotracheal tube.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Anesthesia, Local</condition>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>bilateral erector spinae plane block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient WILL receive bilateral erector spinae plane block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NO BLOCK</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patient will not receive Erector spinae plane block</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>bilateral erector spinae block</intervention_name>
    <description>An ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process.&#xD;
Three muscles; trapezius , rhomboids major , and erector spinae will be identified superior to the hyperechoic transverse process.&#xD;
Using in-plane approach a 25 G needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle.&#xD;
Correct needle tip location will be confirmed by injecting 3 mL of saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..&#xD;
0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread in the fascial plane between the erector spinae muscle andthe transverse process12.</description>
    <arm_group_label>bilateral erector spinae plane block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age:6 months-7 years.&#xD;
&#xD;
          -  ASA, American Society of Anesthesiology, II and III .&#xD;
&#xD;
          -  Patients undergoing cardiac surgeries with midline sternotomy incision.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whose parents or legal guardians refusing to participate.&#xD;
&#xD;
          -  Preoperative mechanical ventilation.&#xD;
&#xD;
          -  Preoperative inotropic drug infusion.&#xD;
&#xD;
          -  Known or suspected coagulopathy.&#xD;
&#xD;
          -  Any congenital anomalies of the sacrum/the vertebral column or any infection at the&#xD;
             site of injection.&#xD;
&#xD;
          -  Known or suspected allergy to any of the studied drugs.&#xD;
&#xD;
          -  Elevated liver enzymes more than the normal values.&#xD;
&#xD;
          -  Renal function impairment (Creatinine value more than 1.2 mg/dl or BUN more than&#xD;
             20mg/dl).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University Hospitals</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835.</citation>
    <PMID>22013248</PMID>
  </reference>
  <reference>
    <citation>Anand KJ, Hickey PR. Halothane-morphine compared with high-dose sufentanil for anesthesia and postoperative analgesia in neonatal cardiac surgery. N Engl J Med. 1992 Jan 2;326(1):1-9. doi: 10.1056/NEJM199201023260101.</citation>
    <PMID>1530752</PMID>
  </reference>
  <reference>
    <citation>El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677.</citation>
    <PMID>24843324</PMID>
  </reference>
  <reference>
    <citation>Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.</citation>
    <PMID>27501016</PMID>
  </reference>
  <reference>
    <citation>Kaushal B, Chauhan S, Magoon R, Krishna NS, Saini K, Bhoi D, Bisoi AK. Efficacy of Bilateral Erector Spinae Plane Block in Management of Acute Postoperative Surgical Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy. J Cardiothorac Vasc Anesth. 2020 Apr;34(4):981-986. doi: 10.1053/j.jvca.2019.08.009. Epub 2019 Aug 12.</citation>
    <PMID>31515190</PMID>
  </reference>
  <reference>
    <citation>Munoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26. No abstract available.</citation>
    <PMID>28447318</PMID>
  </reference>
  <reference>
    <citation>De la Cuadra-Fontaine JC, Concha M, Vuletin F, Arancibia H. Continuous Erector Spinae Plane block for thoracic surgery in a pediatric patient. Paediatr Anaesth. 2018 Jan;28(1):74-75. doi: 10.1111/pan.13277. No abstract available.</citation>
    <PMID>29226529</PMID>
  </reference>
  <reference>
    <citation>Hernandez MA, Palazzi L, Lapalma J, Forero M, Chin KJ. Erector Spinae Plane Block for Surgery of the Posterior Thoracic Wall in a Pediatric Patient. Reg Anesth Pain Med. 2018 Feb;43(2):217-219. doi: 10.1097/AAP.0000000000000716.</citation>
    <PMID>29278605</PMID>
  </reference>
  <reference>
    <citation>Ueshima H, Otake H. RETRACTED: Clinical experiences of erector spinae plane block for children. J Clin Anesth. 2018 Feb;44:41. doi: 10.1016/j.jclinane.2017.10.021. No abstract available.</citation>
    <PMID>29100022</PMID>
  </reference>
  <reference>
    <citation>Kaplan I, Jiao Y, AuBuchon JD, Moore RP. Continuous Erector Spinae Plane Catheter for Analgesia After Infant Thoracotomy: A Case Report. A A Pract. 2018 Nov 1;11(9):250-252. doi: 10.1213/XAA.0000000000000799.</citation>
    <PMID>29794802</PMID>
  </reference>
  <reference>
    <citation>Hernandez MA, Palazzi L, Lapalma J, Cravero J. Erector spinae plane block for inguinal hernia repair in preterm infants. Paediatr Anaesth. 2018 Mar;28(3):298-299. doi: 10.1111/pan.13325. Epub 2018 Jan 17.</citation>
    <PMID>29341379</PMID>
  </reference>
  <reference>
    <citation>Merkel S, Voepel-Lewis T, Malviya S. Pain assessment in infants and young children: the FLACC scale. Am J Nurs. 2002 Oct;102(10):55-8. doi: 10.1097/00000446-200210000-00024. No abstract available.</citation>
    <PMID>12394307</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>December 4, 2021</last_update_submitted>
  <last_update_submitted_qc>December 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>AHMED ALI GADO</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Erector spinae plane block</keyword>
  <keyword>Pediatric</keyword>
  <keyword>sternotomy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The patients data are confidential</ipd_description>
  </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/NCT04452656
org study id: N159-2020
nct id: NCT04452656
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized, double-blinded, study aims to compare the efficacy of analgesia and any side
      effects of U/S guided bilateral Erector SpinaePlane block versus non-block t paediatric
      patients undergoing corrective cardiac surgeries.
Our study will be designed to estimate and compare the analgesic effect of single
      shotbilatral erector spinae plane block in pediatric patients undergoing corrective cardiac
      surgeries versus non-block as the control group. Our primary outcome will be the total dose
      of intraoperative fentanyl boluses.

      Randomization will be achieved by using an online random number generator. Patient codes will
      be placed into sequentially numbered sealed opaque envelopes by a research assistant who is
      not involved in the study. A medical personnel not involved in patient management will be
      responsible for opening the envelope and give the instructions contained within each envelope
      to the anesthesiologist who is expert in doing the ESP block in patients included within the
      block group. The anesthesia team who managed the patients intraoperatively did not share in
      recording data for the research. However, another physcian will be responsible for recording
      the intraoperative data.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the Erector spinae plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.
measure: The total dose of intraoperative fentanyl boluses in microgram.
time frame: 3 months
description: The total dose of intraoperative fentanyl boluses in microgram
measure: Pain assessment at postoperatively by FLACC score
time frame: 3 months
description: Pain assessment postoperatively by FLACC score
measure: Total consumption of morphine during the first 24 hours postoperatively.
time frame: 3 monts
description: Total consumption of morphine during the first 24 hours postoperatively
measure: extubation time
time frame: 3 months
description: time from finishing skin incision suturing and cessation of anesthesia to successful removal of endotracheal tube.
arm group label: bilateral erector spinae plane block
arm group type: Active Comparator
description: The patient WILL receive bilateral erector spinae plane block.
arm group label: NO BLOCK
arm group type: No Intervention
description: The patient will not receive Erector spinae plane block
intervention type: Procedure
intervention name: bilateral erector spinae block
description: An ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process.
Three muscles; trapezius , rhomboids major , and erector spinae will be identified superior to the hyperechoic transverse process.
Using in-plane approach a 25 G needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle.
Correct needle tip location will be confirmed by injecting 3 mL of saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..
0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread in the fascial plane between the erector spinae muscle andthe transverse process12.
arm group label: bilateral erector spinae plane block
criteria: 
gender: All
minimum age: 6 Months
maximum age: 7 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835.
PMID: 22013248
citation: Anand KJ, Hickey PR. Halothane-morphine compared with high-dose sufentanil for anesthesia and postoperative analgesia in neonatal cardiac surgery. N Engl J Med. 1992 Jan 2;326(1):1-9. doi: 10.1056/NEJM199201023260101.
PMID: 1530752
citation: El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677.
PMID: 24843324
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PMID: 27501016
citation: Kaushal B, Chauhan S, Magoon R, Krishna NS, Saini K, Bhoi D, Bisoi AK. Efficacy of Bilateral Erector Spinae Plane Block in Management of Acute Postoperative Surgical Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy. J Cardiothorac Vasc Anesth. 2020 Apr;34(4):981-986. doi: 10.1053/j.jvca.2019.08.009. Epub 2019 Aug 12.
PMID: 31515190
citation: Munoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26. No abstract available.
PMID: 28447318
citation: De la Cuadra-Fontaine JC, Concha M, Vuletin F, Arancibia H. Continuous Erector Spinae Plane block for thoracic surgery in a pediatric patient. Paediatr Anaesth. 2018 Jan;28(1):74-75. doi: 10.1111/pan.13277. No abstract available.
PMID: 29226529
citation: Hernandez MA, Palazzi L, Lapalma J, Forero M, Chin KJ. Erector Spinae Plane Block for Surgery of the Posterior Thoracic Wall in a Pediatric Patient. Reg Anesth Pain Med. 2018 Feb;43(2):217-219. doi: 10.1097/AAP.0000000000000716.
PMID: 29278605
citation: Ueshima H, Otake H. RETRACTED: Clinical experiences of erector spinae plane block for children. J Clin Anesth. 2018 Feb;44:41. doi: 10.1016/j.jclinane.2017.10.021. No abstract available.
PMID: 29100022
citation: Kaplan I, Jiao Y, AuBuchon JD, Moore RP. Continuous Erector Spinae Plane Catheter for Analgesia After Infant Thoracotomy: A Case Report. A A Pract. 2018 Nov 1;11(9):250-252. doi: 10.1213/XAA.0000000000000799.
PMID: 29794802
citation: Hernandez MA, Palazzi L, Lapalma J, Cravero J. Erector spinae plane block for inguinal hernia repair in preterm infants. Paediatr Anaesth. 2018 Mar;28(3):298-299. doi: 10.1111/pan.13325. Epub 2018 Jan 17.
PMID: 29341379
citation: Merkel S, Voepel-Lewis T, Malviya S. Pain assessment in infants and young children: the FLACC scale. Am J Nurs. 2002 Oct;102(10):55-8. doi: 10.1097/00000446-200210000-00024. No abstract available.
PMID: 12394307
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: AHMED ALI GADO
investigator title: Director
sharing ipd: No
ipd description: The patients data are confidential