<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/NCT03260439</url>
  </required_header>
  <id_info>
    <org_study_id>OMB NO: 0925-0586</org_study_id>
    <nct_id>NCT03260439</nct_id>
  </id_info>
  <brief_title>Tramadol in Penial Block Does it Improve Efficiency of Postoperative Analgesia in Circumcision</brief_title>
  <official_title>Doses Tramadol With Bupivacaine in Penial Block Improve Efficiency of Postoperative Analgésia in Children in Circumcision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leila mansali stambouli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Monastir</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After the consent of the local ethics committee and informed consent of the parents, we&#xD;
      conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December&#xD;
      2014, including one to eight year olds, ASA I or II and Programmed for circumcision.We&#xD;
      collected 53 children in each group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After the consent of the local ethics committee and informed consent of the parents, we&#xD;
      conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December&#xD;
      2014, including one to eight year olds, ASA I or II and Programmed for circumcision.&#xD;
      Anesthesia was induced with sevoflurane at 8% and maintained by the same agent at 2%. The&#xD;
      children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV&#xD;
      non-adrenalinated 0.5% / kg on each side with either tramadol 2mg / Kg (G1: GroupBT ) Or&#xD;
      saline serum at the same volume (G2: Group B or control). Postoperative analgesia was&#xD;
      assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO&#xD;
      hour at home, by the number of analgesic inThe hospital and at home, and by the time of the&#xD;
      first demand analgesic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>
    <intervention_model_description>Randomized, controlled and double blind assignment</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative analgesia</measure>
    <time_frame>from awake until 60 min after emergence</time_frame>
    <description>Postoperative analgesia was assessed by modified OPS scale, by the number of the&#xD;
number of analgesic in The hospital and home, and by the time of the first demand analgesic.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Tramadol - Anesthetics- Child - Circumcision</condition>
  <arm_group>
    <arm_group_label>G1 (group BT)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with tramadol 2mg / Kg (G1: GroupBT ). Tramadol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G2 (group B or control)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with saline serum at the same volume (G2: Group B or control). Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tramadol</intervention_name>
    <description>Children receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with tramadol 2mg / Kg (G1: GroupBT ). Postoperativ analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic The hospital and home, and by the time of the first demand analgesic.</description>
    <arm_group_label>G1 (group BT)</arm_group_label>
    <other_name>group BT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Children receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with saline serum at the same volume (G2: Group B or control). Postoperativ analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic The hospital and home, and by the time of the first demand analgesic.</description>
    <arm_group_label>G2 (group B or control)</arm_group_label>
    <other_name>group B or control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status I or II&#xD;
&#xD;
          -  Were scheudled to circumcision surgery&#xD;
&#xD;
          -  Performed by experenced surgeon under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with full stomach&#xD;
&#xD;
          -  A history of gastric reflux&#xD;
&#xD;
          -  A history of cardiovascular or neuromuscular disease&#xD;
&#xD;
          -  Allergies to the study drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>leila Mansali Stambouli, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Fattouma Bourguiba Monastir TUNISIA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Fattouma Bourguiba</name>
      <address>
        <city>Monastir</city>
        <state>Monastir- Tunisia</state>
        <zip>5000</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <reference>
    <citation>Kargi E, Isikdemir A, Tokgoz H, Erol B, Isikdemir F, Hanci V, Payasli C. Comparison of local anesthetic effects of tramadol with prilocaine during circumcision procedure. Urology. 2010 Mar;75(3):672-5. doi: 10.1016/j.urology.2009.06.108. Epub 2009 Oct 24.</citation>
    <PMID>19854483</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Monastir</investigator_affiliation>
    <investigator_full_name>Leila mansali stambouli</investigator_full_name>
    <investigator_title>Principal Investgator and ClinicalProfessor</investigator_title>
  </responsible_party>
  <keyword>tramadol-penile block -circumcision surgery-anesthesia-child</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tramadol</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/NCT03260439
org study id: OMB NO: 0925-0586
nct id: NCT03260439
lead sponsor: 
has dmc: Yes
After the consent of the local ethics committee and informed consent of the parents, we
      conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December
      2014, including one to eight year olds, ASA I or II and Programmed for circumcision.We
      collected 53 children in each group.
After the consent of the local ethics committee and informed consent of the parents, we
      conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December
      2014, including one to eight year olds, ASA I or II and Programmed for circumcision.
      Anesthesia was induced with sevoflurane at 8% and maintained by the same agent at 2%. The
      children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV
      non-adrenalinated 0.5% / kg on each side with either tramadol 2mg / Kg (G1: GroupBT ) Or
      saline serum at the same volume (G2: Group B or control). Postoperative analgesia was
      assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO
      hour at home, by the number of analgesic inThe hospital and at home, and by the time of the
      first demand analgesic.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, controlled and double blind assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Postoperative analgesia
time frame: from awake until 60 min after emergence
description: Postoperative analgesia was assessed by modified OPS scale, by the number of the
number of analgesic in The hospital and home, and by the time of the first demand analgesic.
arm group label: G1 (group BT)
arm group type: Other
description: The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with tramadol 2mg / Kg (G1: GroupBT ). Tramadol
arm group label: G2 (group B or control)
arm group type: Other
description: The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with saline serum at the same volume (G2: Group B or control). Placebo
intervention type: Drug
intervention name: Tramadol
description: Children receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with tramadol 2mg / Kg (G1: GroupBT ). Postoperativ analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic The hospital and home, and by the time of the first demand analgesic.
arm group label: G1 (group BT)
other name: group BT
intervention type: Drug
intervention name: Placebo
description: Children receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with saline serum at the same volume (G2: Group B or control). Postoperativ analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic The hospital and home, and by the time of the first demand analgesic.
arm group label: G2 (group B or control)
other name: group B or control
criteria: 
gender: All
minimum age: 1 Year
maximum age: 8 Years
healthy volunteers: No
last name: leila Mansali Stambouli, MD PhD
role: Principal Investigator
affiliation: University Hospital of Fattouma Bourguiba Monastir TUNISIA
facility: 
country: Tunisia
citation: Kargi E, Isikdemir A, Tokgoz H, Erol B, Isikdemir F, Hanci V, Payasli C. Comparison of local anesthetic effects of tramadol with prilocaine during circumcision procedure. Urology. 2010 Mar;75(3):672-5. doi: 10.1016/j.urology.2009.06.108. Epub 2009 Oct 24.
PMID: 19854483
responsible party type: Sponsor-Investigator
investigator affiliation: University of Monastir
investigator full name: Leila mansali stambouli
investigator title: Principal Investgator and ClinicalProfessor
mesh term: Tramadol
sharing ipd: No