<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/NCT03258255</url>
  </required_header>
  <id_info>
    <org_study_id>242893</org_study_id>
    <nct_id>NCT03258255</nct_id>
  </id_info>
  <brief_title>Analgesic Efficiency of Pudendal Nerve Block Versus Penil Block for Circumsion in Children</brief_title>
  <official_title>Comparison of Analgesic Efficiency of Pudendal Nerve Block and Penil Block for Circumsion in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</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>
      The aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal&#xD;
      block compared with penil block for pediatric patients undergoing circumsion concerning&#xD;
      postoperative analgesic consumption within 24 hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective study, patients will be randomized into 2 groups, either receiving penil&#xD;
      Block( PNL) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will&#xD;
      be assessed during the first 24 hours postoperatively. The &quot;CHEOPS pain scale&quot; will use to&#xD;
      assess postoperative pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain evaluatiom</measure>
    <time_frame>24 hour</time_frame>
    <description>CHEOPS pain scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Postoperative Analgesia</condition>
  <arm_group>
    <arm_group_label>Pudendal block group in circumcision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nerve stimulated pudendal nerve block performed under general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Penil block group in circumcision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Penil block performed by surgeon under general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>penil or pudendal nerve block in circumcision</intervention_name>
    <description>regional analgesia methods during the circumsion nerve stimulator guided pudendal block performed by anesthesiologist/ penil block performed by surgeon before circumcision</description>
    <arm_group_label>Penil block group in circumcision</arm_group_label>
    <arm_group_label>Pudendal block group in circumcision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ASA I-II patients, aged 1-12 years old patient undergoing circumcision,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        history of local anesthetics's allergy, infection at the injection side, anatomical&#xD;
        abnormalities, coagulopaty, bleeding disease, liver disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>November 15, 2017</last_update_submitted>
  <last_update_submitted_qc>November 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Ayse Cigdem Tutuncu</investigator_full_name>
    <investigator_title>assoc prof</investigator_title>
  </responsible_party>
  <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/NCT03258255
org study id: 242893
nct id: NCT03258255
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal
      block compared with penil block for pediatric patients undergoing circumsion concerning
      postoperative analgesic consumption within 24 hours.
In this prospective study, patients will be randomized into 2 groups, either receiving penil
      Block( PNL) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will
      be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to
      assess postoperative pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Postoperative pain evaluatiom
time frame: 24 hour
description: CHEOPS pain scale
arm group label: Pudendal block group in circumcision
arm group type: Active Comparator
description: Nerve stimulated pudendal nerve block performed under general anesthesia
arm group label: Penil block group in circumcision
arm group type: Active Comparator
description: Penil block performed by surgeon under general anesthesia
intervention type: Procedure
intervention name: penil or pudendal nerve block in circumcision
description: regional analgesia methods during the circumsion nerve stimulator guided pudendal block performed by anesthesiologist/ penil block performed by surgeon before circumcision
arm group label: Penil block group in circumcision
arm group label: Pudendal block group in circumcision
criteria: 
gender: Male
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
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
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Ayse Cigdem Tutuncu
investigator title: assoc prof
sharing ipd: No