<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/NCT03016650</url>
  </required_header>
  <id_info>
    <org_study_id>muharrem-1</org_study_id>
    <nct_id>NCT03016650</nct_id>
  </id_info>
  <brief_title>Opioid-sparing Effect of Intravenous Ibuprofen</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Muharrem Ucar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in&#xD;
      patients undergoing percutaneous nephrolithotomy (PCNL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eighty patients who will undergoing PCNL are randomized to intravenous paracetamol (n=40) and&#xD;
      intravenous ibuprofen (n=40) groups. Patients will receive 100 mL of physiologic saline with&#xD;
      1 g IV paracetamol or 800 mg IV ibuprofen 30 minutes before the end of the operation and&#xD;
      postoperatively 6, 12 and 18 hours after PCNL in the paracetamol and ibuprofen groups,&#xD;
      respectively. Patients in both groups will receive intravenous tramadol with patient&#xD;
      controlled analgesia device (PCA).&#xD;
&#xD;
      The visual analog scale (VAS) will used to evaluate pain intensity scores in the&#xD;
      postoperative period.&#xD;
&#xD;
      Total tramadol consumption, mean VAS score in the 1, 8 and 24 hours, demographic variables,&#xD;
      operative variables, and side effects will record.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine Consumption</measure>
    <time_frame>postoperatively 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>postoperatively 30 minute, 2, 4, 6,12 and 24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Analgesia</condition>
  <condition>Percutaneous Nephrolithotomy</condition>
  <arm_group>
    <arm_group_label>Paracetamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 100 mL of physiologic saline with 1 g IV acetaminophen (paracetamol) 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Patients receive 100 mL of physiologic saline with 1 g IV paracetamol 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL</description>
    <arm_group_label>Paracetamol</arm_group_label>
    <other_name>Perfalgan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>Patients receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL</description>
    <arm_group_label>ibuprofen</arm_group_label>
    <other_name>Intrafen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study include 80 patients of American Society of Anesthesiologists (ASA) physical&#xD;
             status I-II aged between 18-70 years who scheduled for percutaneous nephrolithotomy&#xD;
             operation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic pain,&#xD;
&#xD;
          -  psychiatric disease,&#xD;
&#xD;
          -  renal dysfunction,&#xD;
&#xD;
          -  allergy to nonsteroidal anti-inflammatory drugs,&#xD;
&#xD;
          -  history of drug addiction,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  inability to use a patient controlled analgesia (PCA) device.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muharrem Ucar</last_name>
    <role>Principal Investigator</role>
    <affiliation>İnonu University Faculty of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Muharrem Ucar, Asst.Prof.</last_name>
    <phone>+90 422 341 06 60</phone>
    <phone_ext>3136</phone_ext>
    <email>umuharrem@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mehmet ALi ERDOGAN, Ass.Prof.</last_name>
    <phone>+90 422 341 06 60</phone>
    <phone_ext>6419</phone_ext>
    <email>drmalierdogan@gmail.com</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Maghsoudi R, Tabatabai M, Radfar MH, Movasagi G, Etemadian M, Shati M, Amjadi M. Opioid-sparing effect of intravenous paracetamol after percutaneous nephrolithotomy: a double-blind randomized controlled trial. J Endourol. 2014 Jan;28(1):23-7. doi: 10.1089/end.2013.0267. Epub 2013 Oct 17.</citation>
    <PMID>23952097</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Muharrem Ucar</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Acetaminophen</keyword>
  <keyword>Ibuprofen</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</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/NCT03016650
org study id: muharrem-1
nct id: NCT03016650
lead sponsor: 
has dmc: No
The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in
      patients undergoing percutaneous nephrolithotomy (PCNL).
Eighty patients who will undergoing PCNL are randomized to intravenous paracetamol (n=40) and
      intravenous ibuprofen (n=40) groups. Patients will receive 100 mL of physiologic saline with
      1 g IV paracetamol or 800 mg IV ibuprofen 30 minutes before the end of the operation and
      postoperatively 6, 12 and 18 hours after PCNL in the paracetamol and ibuprofen groups,
      respectively. Patients in both groups will receive intravenous tramadol with patient
      controlled analgesia device (PCA).

      The visual analog scale (VAS) will used to evaluate pain intensity scores in the
      postoperative period.

      Total tramadol consumption, mean VAS score in the 1, 8 and 24 hours, demographic variables,
      operative variables, and side effects will record.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Morphine Consumption
time frame: postoperatively 24 hours
measure: Visual Analog Scale
time frame: postoperatively 30 minute, 2, 4, 6,12 and 24 hours
arm group label: Paracetamol
arm group type: Active Comparator
description: Patients will receive 100 mL of physiologic saline with 1 g IV acetaminophen (paracetamol) 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.
arm group label: ibuprofen
arm group type: Active Comparator
description: Patients will receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.
intervention type: Drug
intervention name: Acetaminophen
description: Patients receive 100 mL of physiologic saline with 1 g IV paracetamol 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL
arm group label: Paracetamol
other name: Perfalgan
intervention type: Drug
intervention name: Ibuprofen
description: Patients receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL
arm group label: ibuprofen
other name: Intrafen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Muharrem Ucar
role: Principal Investigator
affiliation: İnonu University Faculty of Medicine
last name: Muharrem Ucar, Asst.Prof.
phone: +90 422 341 06 60
phone ext: 3136
email: umuharrem@hotmail.com
last name: Mehmet ALi ERDOGAN, Ass.Prof.
phone: +90 422 341 06 60
phone ext: 6419
email: drmalierdogan@gmail.com
citation: Maghsoudi R, Tabatabai M, Radfar MH, Movasagi G, Etemadian M, Shati M, Amjadi M. Opioid-sparing effect of intravenous paracetamol after percutaneous nephrolithotomy: a double-blind randomized controlled trial. J Endourol. 2014 Jan;28(1):23-7. doi: 10.1089/end.2013.0267. Epub 2013 Oct 17.
PMID: 23952097
responsible party type: Sponsor-Investigator
investigator affiliation: Inonu University
investigator full name: Muharrem Ucar
investigator title: Principal Investigator
mesh term: Acetaminophen
mesh term: Ibuprofen
sharing ipd: No