<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/NCT04444635</url>
  </required_header>
  <id_info>
    <org_study_id>N110-2020</org_study_id>
    <nct_id>NCT04444635</nct_id>
  </id_info>
  <brief_title>Serratus Anterior Plane Block in Pediatric Patients</brief_title>
  <official_title>Serratus Anterior Plane Block in Pediatric Patients Undergoing Thoracic Surgeries: A Randomized Controlled Trial</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>
      The aim of this work is to study the efficacy of ultrasound guided serratus anterior plane&#xD;
      block in pediatric patients undergoing thoracic surgeries.&#xD;
&#xD;
      It is a randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a prospective randomized controlled study. It is designed to estimate and compare the&#xD;
      analgesic effect of single shot serratus anterior plane block in pediatric patients&#xD;
      undergoing thoracic surgeries with fentanyl infusion versus fentanyl infusion alone as the&#xD;
      control group. Our primary outcome will be the total dose of intra-operative fentanyl&#xD;
      boluses.&#xD;
&#xD;
      Randomization will be achieved by using an online random number generator. Blindness will be&#xD;
      achieved by patient codes which will be placed into sequentially numbered sealed opaque&#xD;
      envelopes by a research assistant who is not involved in the study. A physician not involved&#xD;
      in patient management will be responsible for opening the envelope and give the instructions&#xD;
      contained within each envelope to the anaesthesiologist who is expert in doing the serratus&#xD;
      anterior plane block in patients included within the block group. This expert&#xD;
      anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will&#xD;
      be responsible for patient management and collecting the intraoperative and postoperative&#xD;
      data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2020</start_date>
  <completion_date type="Actual">June 20, 2021</completion_date>
  <primary_completion_date type="Actual">June 10, 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 serratus anterior 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 postoperative operative fentanyl consumption in the first 24 hours.</measure>
    <time_frame>12 months</time_frame>
    <description>The total dose of postoperative operative fentanyl consumption in micrograms in the first 24 hours will be calculated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total dosage of additional fentanyl boluses usage in micrograms intraoperatively</measure>
    <time_frame>12 months</time_frame>
    <description>Total dosage of additional fentanyl boluses usage in micrograms intraoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First rescue analgesia</measure>
    <time_frame>12 months</time_frame>
    <description>Time (in minutes) to 1st rescue analgesia (morphine) post operatively which will be defined to be the elapsed time between stoppage of fentanyl infusion and a patient FLACC score equal or more than 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment postoperatively by Face, Leg, Activity, Cry, Consolability (FLACC) score, minimum is zero, and maximum is 6.</measure>
    <time_frame>12 months</time_frame>
    <description>Pain assessment at 30 min, 60 min, 2 hours, 4hours, 8hours postoperatively by FLACC score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra and postoperative heart rate.</measure>
    <time_frame>12 months</time_frame>
    <description>Intra and postoperative heart rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative and postoperative systolic blood pressure.</measure>
    <time_frame>12 months</time_frame>
    <description>Intraoperative and postoperative systolic blood pressure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Serratus Anterior Plan block plus fentanyl infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl infusion only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient will receive fentanyl infusion only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Serratus Anterior Plan Block+ Fentanyl infusion</intervention_name>
    <description>After induction of anesthesia, the patients will be put on the lateral position with the diseased side up. A linear ultrasound transducer will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage.&#xD;
Then counting down ribs till the fifth rib will be identified in the mid-axillary line. The following muscles will be identified overlying the fifth rib: the latissimus dorsi (superficial and posterior),teres major (superior) and serratus muscles (deep and inferior). Under complete sterile conditions, the needle (25 G needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus anterior muscle. Then, 2 mg/kg of 0.25% bupivacaine will be injected with continuous ultrasound guidance. In addition to continuous fentanyl infusion</description>
    <arm_group_label>Serratus Anterior Plan block plus fentanyl infusion</arm_group_label>
    <other_name>Serratus Anterior Plan Block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Continuous fentanyl infusion throughout the surgical procedure.</description>
    <arm_group_label>Fentanyl infusion only</arm_group_label>
    <arm_group_label>Serratus Anterior Plan block plus fentanyl infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 6 months-3 years.&#xD;
&#xD;
          -  American Society of anesthesiology (ASA) I and II.&#xD;
&#xD;
          -  Pediatric patients undergoing thoracic surgeries (with anterior thoracotomy incision).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whose parents or legal guardians refusing to participate.&#xD;
&#xD;
          -  Preoperative mechanical ventilation.&#xD;
&#xD;
          -  Known or suspected coagulopathy.&#xD;
&#xD;
          -  Infection at the 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;
          -  Procedures with anticipated significant hemodynamic stability.&#xD;
&#xD;
          -  Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen&#xD;
             (BUN) more than 20mg/dl).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AHMED ISMAIL, Lecturer</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University Hospitals</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Lonnqvist PA, Morton NS. Postoperative analgesia in infants and children. Br J Anaesth. 2005 Jul;95(1):59-68. doi: 10.1093/bja/aei065. Epub 2005 Jan 21. No abstract available. Erratum In: Br J Anaesth. 2005 Nov;95(5):725.</citation>
    <PMID>15668207</PMID>
  </reference>
  <reference>
    <citation>Senturk M, Ozcan PE, Talu GK, Kiyan E, Camci E, Ozyalcin S, Dilege S, Pembeci K. The effects of three different analgesia techniques on long-term postthoracotomy pain. Anesth Analg. 2002 Jan;94(1):11-5, table of contents. doi: 10.1213/00000539-200201000-00003.</citation>
    <PMID>11772793</PMID>
  </reference>
  <reference>
    <citation>Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.</citation>
    <PMID>11020770</PMID>
  </reference>
  <reference>
    <citation>Rogers ML, Henderson L, Mahajan RP, Duffy JP. Preliminary findings in the neurophysiological assessment of intercostal nerve injury during thoracotomy. Eur J Cardiothorac Surg. 2002 Feb;21(2):298-301. doi: 10.1016/s1010-7940(01)01104-6.</citation>
    <PMID>11825739</PMID>
  </reference>
  <results_reference>
    <citation>Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.</citation>
    <PMID>23923989</PMID>
  </results_reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 23, 2021</last_update_submitted>
  <last_update_submitted_qc>June 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Abdelaziz Ismail</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>Serratus anterior plane block</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Thoracotomy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
  </intervention_browse>
  <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/NCT04444635
org study id: N110-2020
nct id: NCT04444635
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this work is to study the efficacy of ultrasound guided serratus anterior plane
      block in pediatric patients undergoing thoracic surgeries.

      It is a randomized controlled trial.
It is a prospective randomized controlled study. It is designed to estimate and compare the
      analgesic effect of single shot serratus anterior plane block in pediatric patients
      undergoing thoracic surgeries with fentanyl infusion versus fentanyl infusion alone as the
      control group. Our primary outcome will be the total dose of intra-operative fentanyl
      boluses.

      Randomization will be achieved by using an online random number generator. 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 serratus
      anterior 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.
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 serratus anterior 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 postoperative operative fentanyl consumption in the first 24 hours.
time frame: 12 months
description: The total dose of postoperative operative fentanyl consumption in micrograms in the first 24 hours will be calculated
measure: Total dosage of additional fentanyl boluses usage in micrograms intraoperatively
time frame: 12 months
description: Total dosage of additional fentanyl boluses usage in micrograms intraoperatively
measure: First rescue analgesia
time frame: 12 months
description: Time (in minutes) to 1st rescue analgesia (morphine) post operatively which will be defined to be the elapsed time between stoppage of fentanyl infusion and a patient FLACC score equal or more than 4.
measure: Pain assessment postoperatively by Face, Leg, Activity, Cry, Consolability (FLACC) score, minimum is zero, and maximum is 6.
time frame: 12 months
description: Pain assessment at 30 min, 60 min, 2 hours, 4hours, 8hours postoperatively by FLACC score.
measure: Intra and postoperative heart rate.
time frame: 12 months
description: Intra and postoperative heart rate.
measure: Intraoperative and postoperative systolic blood pressure.
time frame: 12 months
description: Intraoperative and postoperative systolic blood pressure.
arm group label: Serratus Anterior Plan block plus fentanyl infusion
arm group type: Active Comparator
description: The patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion.
arm group label: Fentanyl infusion only
arm group type: Active Comparator
description: The patient will receive fentanyl infusion only.
intervention type: Procedure
intervention name: Serratus Anterior Plan Block+ Fentanyl infusion
description: After induction of anesthesia, the patients will be put on the lateral position with the diseased side up. A linear ultrasound transducer will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage.
Then counting down ribs till the fifth rib will be identified in the mid-axillary line. The following muscles will be identified overlying the fifth rib: the latissimus dorsi (superficial and posterior),teres major (superior) and serratus muscles (deep and inferior). Under complete sterile conditions, the needle (25 G needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus anterior muscle. Then, 2 mg/kg of 0.25% bupivacaine will be injected with continuous ultrasound guidance. In addition to continuous fentanyl infusion
arm group label: Serratus Anterior Plan block plus fentanyl infusion
other name: Serratus Anterior Plan Block
intervention type: Drug
intervention name: Fentanyl
description: Continuous fentanyl infusion throughout the surgical procedure.
arm group label: Fentanyl infusion only
arm group label: Serratus Anterior Plan block plus fentanyl infusion
criteria: 
gender: All
minimum age: 6 Months
maximum age: 3 Years
healthy volunteers: No
last name: AHMED ISMAIL, Lecturer
role: Study Director
affiliation: Cairo University Hospitals
facility: 
country: Egypt
citation: Lonnqvist PA, Morton NS. Postoperative analgesia in infants and children. Br J Anaesth. 2005 Jul;95(1):59-68. doi: 10.1093/bja/aei065. Epub 2005 Jan 21. No abstract available. Erratum In: Br J Anaesth. 2005 Nov;95(5):725.
PMID: 15668207
citation: Senturk M, Ozcan PE, Talu GK, Kiyan E, Camci E, Ozyalcin S, Dilege S, Pembeci K. The effects of three different analgesia techniques on long-term postthoracotomy pain. Anesth Analg. 2002 Jan;94(1):11-5, table of contents. doi: 10.1213/00000539-200201000-00003.
PMID: 11772793
citation: Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
PMID: 11020770
citation: Rogers ML, Henderson L, Mahajan RP, Duffy JP. Preliminary findings in the neurophysiological assessment of intercostal nerve injury during thoracotomy. Eur J Cardiothorac Surg. 2002 Feb;21(2):298-301. doi: 10.1016/s1010-7940(01)01104-6.
PMID: 11825739
citation: Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
PMID: 23923989
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Abdelaziz Ismail
investigator title: Principle investigator
mesh term: Fentanyl
sharing ipd: No
ipd description: The patients data are confidential