<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/NCT03298646</url>
  </required_header>
  <id_info>
    <org_study_id>Hysteroscopy</org_study_id>
    <nct_id>NCT03298646</nct_id>
  </id_info>
  <brief_title>Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy</brief_title>
  <official_title>Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy: A Randomized Controlled 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During&#xD;
      Outpatient Hysteroscopy. A Randomized Controlled Trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      10 ml of 2% lidocaine hydrochloride added on saline infusion media versus 100 mg diclofenac&#xD;
      tablet 1 hour before office hysteroscopy , to test their efficacy in reducing pain .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain reduction using Visual Analogue Scale</measure>
    <time_frame>30 minutes</time_frame>
    <description>Efficacy of lidocaine on saline media and oral diclofenac in reducing pain during office hysteroscopy from start of the procedure till 30 minutes after, using visual analogue scale to assess the severity of pain</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Nulliparity</condition>
  <arm_group>
    <arm_group_label>Lidacaine hydrochloride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adding 10 ml of 2% Lidocaine hydrochloride on hysteroscopic saline media during office hysteroscopy to test its efficacy in reducing pain.&#xD;
22 women.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 mg Diclofenac oral tablet is administered 1 hour before the procedure to test its efficacy in reducing pain.&#xD;
22 women.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Hydrochloride</intervention_name>
    <description>10 ml of 2% lidocaine on hysteroscopic infusion media during office hysteroscopy.</description>
    <arm_group_label>Lidacaine hydrochloride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac</intervention_name>
    <description>100 mg Diclofenac oral tablet one hour before the procedure.</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.&#xD;
&#xD;
          -  Nulliparous women assigned for diagnostic hysteroscopy.&#xD;
&#xD;
          -  Informed written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous cervical surgery.&#xD;
&#xD;
          -  Cervical stenosis.&#xD;
&#xD;
          -  Known gastritis.&#xD;
&#xD;
          -  Recent or active PID.&#xD;
&#xD;
          -  Cardiac patients.&#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 maternity hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ain shams university</last_name>
      <phone>01005646995</phone>
      <email>elbohoty79@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>ahmed elbohoty</last_name>
      <phone>01005646995</phone>
    </contact_backup>
    <investigator>
      <last_name>Ahmed E Elbohoty, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ahmed Elsayed Hassan Elbohoty</investigator_full_name>
    <investigator_title>Assistant professor</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/NCT03298646
org study id: Hysteroscopy
nct id: NCT03298646
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During
      Outpatient Hysteroscopy. A Randomized Controlled Trial.
10 ml of 2% lidocaine hydrochloride added on saline infusion media versus 100 mg diclofenac
      tablet 1 hour before office hysteroscopy , to test their efficacy in reducing pain .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Care Provider)
measure: Pain reduction using Visual Analogue Scale
time frame: 30 minutes
description: Efficacy of lidocaine on saline media and oral diclofenac in reducing pain during office hysteroscopy from start of the procedure till 30 minutes after, using visual analogue scale to assess the severity of pain
arm group label: Lidacaine hydrochloride
arm group type: Experimental
description: Adding 10 ml of 2% Lidocaine hydrochloride on hysteroscopic saline media during office hysteroscopy to test its efficacy in reducing pain.
22 women.
arm group label: Diclofenac
arm group type: Active Comparator
description: 100 mg Diclofenac oral tablet is administered 1 hour before the procedure to test its efficacy in reducing pain.
22 women.
intervention type: Drug
intervention name: Lidocaine Hydrochloride
description: 10 ml of 2% lidocaine on hysteroscopic infusion media during office hysteroscopy.
arm group label: Lidacaine hydrochloride
intervention type: Drug
intervention name: Diclofenac
description: 100 mg Diclofenac oral tablet one hour before the procedure.
arm group label: Diclofenac
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ahmed Elsayed Hassan Elbohoty
investigator title: Assistant professor
mesh term: Diclofenac
mesh term: Lidocaine