<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/NCT04505657</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/351/5/19</org_study_id>
    <nct_id>NCT04505657</nct_id>
  </id_info>
  <brief_title>Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography</brief_title>
  <official_title>Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aswan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      our aims to investigate the effectiveness of10% Lidocaine Spray plus oral celecoxib for Pain&#xD;
      Control During Hysterosalpingography&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to&#xD;
      grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions&#xD;
      including measuring uterine depth, inserting the cannula; and injection of the dye&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">September 27, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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 trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>randomized controlled trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean pain score during the procedure</measure>
    <time_frame>10 minuets</time_frame>
    <description>Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>IUCD Complication</condition>
  <arm_group>
    <arm_group_label>Celecoxib plus lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Celecoxib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>celecoxib plus lidocaine</intervention_name>
    <description>Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure</description>
    <arm_group_label>Celecoxib plus lidocaine</arm_group_label>
    <other_name>experimental</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Celecoxib</intervention_name>
    <description>Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure</description>
    <arm_group_label>Celecoxib</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lidocaine</intervention_name>
    <description>placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure</description>
    <arm_group_label>lidocaine</arm_group_label>
    <other_name>Active Comparato</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any patient came for Hysterosalpingography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any patient has contraindication to Hysterosalpingography&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female request hystrosalpingogram</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>nahla w Shady, md</last_name>
    <role>Study Chair</role>
    <affiliation>Aswan universirty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aswan University Hospital</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aswan University Hospital</investigator_affiliation>
    <investigator_full_name>hany farouk</investigator_full_name>
    <investigator_title>A Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celecoxib</mesh_term>
    <mesh_term>Lidocaine</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/NCT04505657
org study id: aswu/351/5/19
nct id: NCT04505657
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
our aims to investigate the effectiveness of10% Lidocaine Spray plus oral celecoxib for Pain
      Control During Hysterosalpingography
hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to
      grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions
      including measuring uterine depth, inserting the cannula; and injection of the dye
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled trial
primary purpose: Prevention
masking: Single (Participant)
masking description: randomized controlled trial
measure: Mean pain score during the procedure
time frame: 10 minuets
description: Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores
arm group label: Celecoxib plus lidocaine
arm group type: Experimental
description: Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure
arm group label: Celecoxib
arm group type: Active Comparator
description: Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure
arm group label: lidocaine
arm group type: Active Comparator
description: placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure
intervention type: Drug
intervention name: celecoxib plus lidocaine
description: Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure
arm group label: Celecoxib plus lidocaine
other name: experimental
intervention type: Drug
intervention name: Celecoxib
description: Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure
arm group label: Celecoxib
other name: Active Comparator
intervention type: Drug
intervention name: lidocaine
description: placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure
arm group label: lidocaine
other name: Active Comparato
criteria: 
gender: Female
gender based: Yes
gender description: female request hystrosalpingogram
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: nahla w Shady, md
role: Study Chair
affiliation: Aswan universirty
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: A Professor
mesh term: Celecoxib
mesh term: Lidocaine
sharing ipd: No