<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/NCT03825016</url>
  </required_header>
  <id_info>
    <org_study_id>AS1855</org_study_id>
    <nct_id>NCT03825016</nct_id>
  </id_info>
  <brief_title>Lidocaine Infusion in Hystroscopy</brief_title>
  <official_title>Lidocaine Infusion Versus Oral Diclofenac During Outpatient Hystroscopy: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      Lidocaine infusion in hystroscopic media versus oral diclofenac&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">January 10, 2020</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Degree of pain &quot;measured by visual analogue scale&quot;</measure>
    <time_frame>1 hour</time_frame>
    <description>measured by visual analogue scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lidocaine Hydrochloride</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Diclofenac</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Hydrochloride</intervention_name>
    <description>Lidocaine infusion on hystroscopic media during office hystroscopy</description>
    <arm_group_label>Lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac Sodium</intervention_name>
    <description>Oral Diclofenac Sodium</description>
    <arm_group_label>Diclofenac</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-35 years&#xD;
&#xD;
          -  BMI 18.5-30 kg/m2&#xD;
&#xD;
          -  Diagnostic hystroscope&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous cervical surgery&#xD;
&#xD;
          -  Cervical stenosis&#xD;
&#xD;
          -  PID&#xD;
&#xD;
          -  allergy to NSAID&#xD;
&#xD;
          -  Gastritis or peptic ulcer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 26, 2020</last_update_submitted>
  <last_update_submitted_qc>January 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Mohamed S Sweed, MD</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>Diclofenac</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03825016
org study id: AS1855
nct id: NCT03825016
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Lidocaine infusion in hystroscopic media versus oral diclofenac
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Degree of pain "measured by visual analogue scale"
time frame: 1 hour
description: measured by visual analogue scale
arm group label: Lidocaine
arm group type: Experimental
description: Lidocaine Hydrochloride
arm group label: Diclofenac
arm group type: Experimental
description: Oral Diclofenac
intervention type: Drug
intervention name: Lidocaine Hydrochloride
description: Lidocaine infusion on hystroscopic media during office hystroscopy
arm group label: Lidocaine
intervention type: Drug
intervention name: Diclofenac Sodium
description: Oral Diclofenac Sodium
arm group label: Diclofenac
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Mohamed S Sweed, MD
investigator title: Principal Investigator
mesh term: Diclofenac
mesh term: Lidocaine