<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/NCT04475458</url>
  </required_header>
  <id_info>
    <org_study_id>Ultrasound guided DPNB</org_study_id>
    <nct_id>NCT04475458</nct_id>
  </id_info>
  <brief_title>Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing</brief_title>
  <official_title>Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing: An Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Sanitaria-Universitaria Integrata di Udine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Sanitaria-Universitaria Integrata di Udine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of the most frequent surgical procedures in the pediatric population is circumcision,&#xD;
      following which postoperative pain could be stressful. Usually, the most common approach is&#xD;
      combining regional anesthesia techniques such as landmark dorsal penile nerve block (DPNB)&#xD;
      with general anesthesia (GA). The hypothesis of this study investigates ultrasound-guided&#xD;
      DPNB plus sedation in spontaneous breathing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">October 1, 2021</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to discharge</measure>
    <time_frame>1 hour after end of surgery</time_frame>
    <description>The time to discharge from the operating room to the post-anesthesia care unit is measured and compared between the two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients needed ventilation</measure>
    <time_frame>1 hour after beginning of surgery</time_frame>
    <description>Patients who received general anesthesia where all ventilated mechanically. In the ultrasound group, patients maintained spontaneous breathing and were noted the ones who needed ventilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid sparing</measure>
    <time_frame>1 hour after beginning of surgery</time_frame>
    <description>The dosage of opioids were measured and compared between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Immediately after surgery, 4 and 72 hours after surgery</time_frame>
    <description>Pain levels were compared between the two groups with the Faces, Legs, Activity, Cry and Consolability (FLACC) scale for children &lt; 3 years (a score between 0 and 3 corresponds to a slight pain, in the range 4-7 to moderate pain and score&gt; 7 to a severe pain), faces pain scale for children between 3 e 8 years (the scale shows a series of faces ranging from a happy face or no hurt at score 0, to a crying face at score 10, which represents &quot;hurts like the worst pain imaginable&quot;, the patient chooses the face that best describes their level of pain) and the numerical rate scale (NRS) for children &gt; 8 years-old (patients are asked to circle the number between 0 and 10 that fits best to their pain intensity, zero represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'). Analgesics and nonsteroidal anti-inflammatory drugs were registered in the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Immediately after surgery, 4 and 72 hours after surgery</time_frame>
    <description>Postoperative complications were analyzed and compared between the two groups.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Child, Only</condition>
  <arm_group>
    <arm_group_label>LANDMARK</arm_group_label>
    <description>The children who underwent circumcision received general anesthesia plus dorsal penis nerve block performed by the surgeon with a landmark technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ULTRASOUND</arm_group_label>
    <description>The children who underwent circumcision received sedation (in spontaneous breathing) plus ultrasound-guided dorsal penis nerve block.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-guided dorsal penile nerve block</intervention_name>
    <description>This block is performed by the anesthesiologist, after sedation. With an in-plane approach, the tissues around the dorsal penis nerves are visualized. The needle has to pass through Buck's fascia and there the local anesthetic is released.</description>
    <arm_group_label>ULTRASOUND</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients' anthropometric data were collected. Data related to the anesthetic technique,&#xD;
        pharmacological therapy, vital parameters were registered as well as the time to discharge&#xD;
        from the operatory room to the post-anesthesia care unit.&#xD;
&#xD;
        Opioid consumption and nonsteroidal anti-inflammatory drugs during and after surgery were&#xD;
        noted. Pain and complications immediately after surgery, at 4 and 72 hours after surgery&#xD;
        were registered.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  candidates to circumcision&#xD;
&#xD;
          -  age between 6 months and 17 years&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status &lt; 3&#xD;
&#xD;
          -  written consent of the parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergies to local anesthetics&#xD;
&#xD;
          -  younger than 6 months and older than 17 years&#xD;
&#xD;
          -  ASA physical status =/&gt; 3&#xD;
&#xD;
          -  no written consent of the parents&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.</citation>
    <PMID>18843636</PMID>
  </reference>
  <reference>
    <citation>Suleman MI, Akbar Ali AN, Kanarek V, Li M, Patel A. Ultrasound Guided In-Plane Penile Nerve Block for Circumcision: A New, Modified Technique Suggests Lower Anesthetic Volume and Narcotic Use. Middle East J Anaesthesiol. 2016 Oct;23(6):647-53.</citation>
    <PMID>29939703</PMID>
  </reference>
  <reference>
    <citation>Sandeman DJ, Dilley AV. Ultrasound guided dorsal penile nerve block in children. Anaesth Intensive Care. 2007 Apr;35(2):266-9. doi: 10.1177/0310057X0703500217.</citation>
    <PMID>17444318</PMID>
  </reference>
  <reference>
    <citation>O'Sullivan MJ, Mislovic B, Alexander E. Dorsal penile nerve block for male pediatric circumcision--randomized comparison of ultrasound-guided vs anatomical landmark technique. Paediatr Anaesth. 2011 Dec;21(12):1214-8. doi: 10.1111/j.1460-9592.2011.03722.x.</citation>
    <PMID>22023417</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>November 5, 2022</last_update_submitted>
  <last_update_submitted_qc>November 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Sanitaria-Universitaria Integrata di Udine</investigator_affiliation>
    <investigator_full_name>Luigi Vetrugno</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>dorsal nerve penis block</keyword>
  <keyword>sedation</keyword>
  <keyword>spontaneous breathing</keyword>
  <keyword>circumcision</keyword>
  <keyword>pediatric surgery</keyword>
  <keyword>ultrasound guided</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <!-- 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/NCT04475458
org study id: Ultrasound guided DPNB
nct id: NCT04475458
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
One of the most frequent surgical procedures in the pediatric population is circumcision,
      following which postoperative pain could be stressful. Usually, the most common approach is
      combining regional anesthesia techniques such as landmark dorsal penile nerve block (DPNB)
      with general anesthesia (GA). The hypothesis of this study investigates ultrasound-guided
      DPNB plus sedation in spontaneous breathing.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Time to discharge
time frame: 1 hour after end of surgery
description: The time to discharge from the operating room to the post-anesthesia care unit is measured and compared between the two groups.
measure: Number of patients needed ventilation
time frame: 1 hour after beginning of surgery
description: Patients who received general anesthesia where all ventilated mechanically. In the ultrasound group, patients maintained spontaneous breathing and were noted the ones who needed ventilation.
measure: Opioid sparing
time frame: 1 hour after beginning of surgery
description: The dosage of opioids were measured and compared between the two groups.
measure: Postoperative pain
time frame: Immediately after surgery, 4 and 72 hours after surgery
description: Pain levels were compared between the two groups with the Faces, Legs, Activity, Cry and Consolability (FLACC) scale for children < 3 years (a score between 0 and 3 corresponds to a slight pain, in the range 4-7 to moderate pain and score> 7 to a severe pain), faces pain scale for children between 3 e 8 years (the scale shows a series of faces ranging from a happy face or no hurt at score 0, to a crying face at score 10, which represents "hurts like the worst pain imaginable", the patient chooses the face that best describes their level of pain) and the numerical rate scale (NRS) for children > 8 years-old (patients are asked to circle the number between 0 and 10 that fits best to their pain intensity, zero represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'). Analgesics and nonsteroidal anti-inflammatory drugs were registered in the two groups.
measure: Complications
time frame: Immediately after surgery, 4 and 72 hours after surgery
description: Postoperative complications were analyzed and compared between the two groups.
arm group label: LANDMARK
description: The children who underwent circumcision received general anesthesia plus dorsal penis nerve block performed by the surgeon with a landmark technique.
arm group label: ULTRASOUND
description: The children who underwent circumcision received sedation (in spontaneous breathing) plus ultrasound-guided dorsal penis nerve block.
intervention type: Procedure
intervention name: Ultrasound-guided dorsal penile nerve block
description: This block is performed by the anesthesiologist, after sedation. With an in-plane approach, the tissues around the dorsal penis nerves are visualized. The needle has to pass through Buck's fascia and there the local anesthetic is released.
arm group label: ULTRASOUND
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 6 Months
maximum age: 17 Years
healthy volunteers: No
facility: 
country: Italy
citation: Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.
PMID: 18843636
citation: Suleman MI, Akbar Ali AN, Kanarek V, Li M, Patel A. Ultrasound Guided In-Plane Penile Nerve Block for Circumcision: A New, Modified Technique Suggests Lower Anesthetic Volume and Narcotic Use. Middle East J Anaesthesiol. 2016 Oct;23(6):647-53.
PMID: 29939703
citation: Sandeman DJ, Dilley AV. Ultrasound guided dorsal penile nerve block in children. Anaesth Intensive Care. 2007 Apr;35(2):266-9. doi: 10.1177/0310057X0703500217.
PMID: 17444318
citation: O'Sullivan MJ, Mislovic B, Alexander E. Dorsal penile nerve block for male pediatric circumcision--randomized comparison of ultrasound-guided vs anatomical landmark technique. Paediatr Anaesth. 2011 Dec;21(12):1214-8. doi: 10.1111/j.1460-9592.2011.03722.x.
PMID: 22023417
responsible party type: Principal Investigator
investigator affiliation: Azienda Sanitaria-Universitaria Integrata di Udine
investigator full name: Luigi Vetrugno
investigator title: Prof.
mesh term: Respiratory Aspiration