<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/NCT04410588</url>
  </required_header>
  <id_info>
    <org_study_id>marwawael</org_study_id>
    <nct_id>NCT04410588</nct_id>
  </id_info>
  <brief_title>Effect of Fentanyl With Topical Levobupivacaine With Nasal Packing in Endoscopic Nasal Surgery</brief_title>
  <acronym>fentanyl</acronym>
  <official_title>Effect of Fentanyl With Topical Levobupivacaine With Nasal Packing in Endoscopic Nasal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</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 Investigators aim to study the effect of fentanyl with topical levobupivacaine with nasal&#xD;
      packing in endoscopic nasal surgery&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 20, 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pain by visual analoge score</measure>
    <time_frame>24 houres postoperative pain assessment</time_frame>
    <description>assessment of pain on removal of nasal packing after endoscopic nasal surgery by VAS score. The Visual Analogue Scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Analgesia During Removal of Nasal Pack After Nasal Surgery</condition>
  <arm_group>
    <arm_group_label>saline</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>saline for pain for nasal packing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>levobupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>levobupivacaine for pain of nasal packing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fentanyl +levobupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>fentanyle with levobupivacaine for pain of nasal packing</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl + Topical Levobupivacaine</intervention_name>
    <description>in nasal packing</description>
    <arm_group_label>fentanyl +levobupivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>levobupivacaine</intervention_name>
    <description>in nasal packing</description>
    <arm_group_label>levobupivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:1. All patients in the age of 18-60 year 2. ASA I-II 3. Undergoing&#xD;
        elective nasal endoscopic surgery&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients will also be excluded if any perioperative cardiovascular or respiratory&#xD;
             event occurred which the anaesthetist with clinical responsibility for the patient&#xD;
             thought would make the study intervention clinically unacceptable.&#xD;
&#xD;
          2. unsatisfactory preoperative peripheral arterial oxygen saturation.&#xD;
&#xD;
          3. Unsatisfactory preoperative hemoglobin level.&#xD;
&#xD;
          4. Neurological or psychiatric disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marwa M Abdelrady</last_name>
    <phone>01006805857</phone>
    <email>marwarady-2012@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>wesam A Nashat</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wael</name>
      <address>
        <city>Assiut</city>
        <state>Asyut</state>
        <zip>11711</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wael m abdelrady</last_name>
      <phone>01006805857</phone>
      <email>marwarady-2012@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Marwa mahmoud Abd El Rady</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Levobupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04410588
org study id: marwawael
nct id: NCT04410588
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the Investigators aim to study the effect of fentanyl with topical levobupivacaine with nasal
      packing in endoscopic nasal surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: postoperative pain by visual analoge score
time frame: 24 houres postoperative pain assessment
description: assessment of pain on removal of nasal packing after endoscopic nasal surgery by VAS score. The Visual Analogue Scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain)
arm group label: saline
arm group type: No Intervention
description: saline for pain for nasal packing
arm group label: levobupivacaine
arm group type: Active Comparator
description: levobupivacaine for pain of nasal packing
arm group label: fentanyl +levobupivacaine
arm group type: Active Comparator
description: fentanyle with levobupivacaine for pain of nasal packing
intervention type: Drug
intervention name: Fentanyl + Topical Levobupivacaine
description: in nasal packing
arm group label: fentanyl +levobupivacaine
intervention type: Drug
intervention name: levobupivacaine
description: in nasal packing
arm group label: levobupivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Marwa M Abdelrady
phone: 01006805857
email: marwarady-2012@hotmail.com
last name: wesam A Nashat
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Marwa mahmoud Abd El Rady
investigator title: Principal Investigator
mesh term: Fentanyl
mesh term: Levobupivacaine
sharing ipd: Yes