<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/NCT03802032</url>
  </required_header>
  <id_info>
    <org_study_id>Ahmadu Bello University</org_study_id>
    <nct_id>NCT03802032</nct_id>
  </id_info>
  <brief_title>Topical Analgesia for Pain Relief in Hysterosalpingography</brief_title>
  <acronym>HSG</acronym>
  <official_title>Effect of Topical Xylocaine for Pain Relief During Hysterosalpingography Among Infertile Women in Zaria, Nigeria: A Randomised Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahmadu Bello University Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ahmadu Bello University Teaching Hospital</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 study will involve giving topical analgesia or placebo and then assessing pain and&#xD;
      satisfaction during and after the procedure in order to see wed to the placebo.hether the&#xD;
      topical analgesia has helped in decreasing pain associated with the procedure and also&#xD;
      whether it has increasedd satisfaction with the procedure compar&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY DESIGN:&#xD;
&#xD;
      The study will be a double blind randomized controlled trial. Group A:The study group will be&#xD;
      given topical Xylocaine (2% Lidocaine) before the procedure.&#xD;
&#xD;
      Group B:The control group will be given topical K-Y jelly (water based lubricant) before the&#xD;
      procedure.&#xD;
&#xD;
      The participants and the radiologist will be blinded at the point of drug administration.&#xD;
&#xD;
      SAMPLE SIZE DETERMINATION:&#xD;
&#xD;
      The formula below was used to calculate the sample size n= (Zα + Zβ)2S2 d2&#xD;
&#xD;
      Assuming a difference in mean pain score among groups of 1.5 and using a standard deviation&#xD;
      of of 3.15.&#xD;
&#xD;
      Zα = standard normal deviate. Zβ = power = 95% = 1.64. S = standard deviation = 3.1. D = mean&#xD;
      difference in pain score = 1.5 n = (1.96 + 1.64)2 x 3.12 1.52&#xD;
&#xD;
      n = 55 Sample size per group will be rounded up to 60&#xD;
&#xD;
      SAMPLING APPROACH:&#xD;
&#xD;
      A probability sampling method will be used. Simple random sampling using a computer generated&#xD;
      table of random numbers will be used. The WINPEPI version 11.65 software will generate the&#xD;
      table of random numbers. The numbers 001-140 will be randomly allocated to two groups A and&#xD;
      B. Group A will be the study group and group B will be the control group (see appendix). Each&#xD;
      number from the table of random numbers will be copied on separate paper and then sealed in a&#xD;
      brown envelope. The envelopes will then be kept inside a box after shuffling.&#xD;
&#xD;
      Each patient will be allocated to the group that the number she picks corresponds to on the&#xD;
      computer printout. The numbers were made up to 140 to make up for patients that may&#xD;
      eventually drop out from the study.&#xD;
&#xD;
      .&#xD;
&#xD;
      SAMPLING RECRUITEMENT:&#xD;
&#xD;
      Women that fulfil the inclusion criteria will be recruited from radiology department as they&#xD;
      present for Hysterosalpingogram. After obtaining a written consent, participants will be&#xD;
      requested to pick one of the brown envelopes which will contain the randomization group.&#xD;
&#xD;
      BLINDING The drugs to be used (K-Y Jelly and Xylocaine gel) are identical.&#xD;
&#xD;
      DATA COLLECTION METHOD:&#xD;
&#xD;
      An informed written consent will be obtained from participants. Psychological support will be&#xD;
      given to the participant by a nurse after the procedure has been explained to the&#xD;
      participant. A questionnaire will then be filled. The participant will then be requested to&#xD;
      pick an envelope that represents the study number. A detailed explanation about the VAS and&#xD;
      its application was given personally to each woman before the procedure. An interviewer&#xD;
      administered questionnaire will be used to obtain information on socio-demographic&#xD;
      characteristics, reproductive profile, previous history of the procedure and experience with&#xD;
      analgesia.&#xD;
&#xD;
      The analgesic or placebo will be applied to the cervix (15ml) using a vaginal applicator 10&#xD;
      minutes before the procedure.&#xD;
&#xD;
      The procedure will then be done using standard clinical protocol. The pain rating scale will&#xD;
      be used to evaluate pain during from zero (no pain) to ten (worst possible pain) will be&#xD;
      explained to the client. The visual scale comparison to happy, glum, sad and horrified faces&#xD;
      will also be explained to the patient.&#xD;
&#xD;
      Pain assessment will be done during the procedure at the following steps:&#xD;
&#xD;
        1. After application of speculum.&#xD;
&#xD;
        2. After cervical manipulation (application of tenaculum and catheter).&#xD;
&#xD;
        3. After filling the uterus with contrast medium.&#xD;
&#xD;
        4. After withdrawal of speculum and catheter.&#xD;
&#xD;
        5. Thirty minutes after completing the procedure.&#xD;
&#xD;
      The Likert scale will be used to assess patient satisfaction following pain management.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 22, 2019</completion_date>
  <primary_completion_date type="Actual">December 22, 2019</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>A randomised controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>Double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain perception</measure>
    <time_frame>witthin 45 minutes of the procedure</time_frame>
    <description>The pain score based on visual pain scale that assesses pain perception. It is a scale of 0 to 10.&#xD;
0 = absence of pain.&#xD;
= discomfort&#xD;
= mild pain.&#xD;
= annoying pain.&#xD;
= nagging pain.&#xD;
= distressing pain.&#xD;
= miserable.&#xD;
= intense&#xD;
= Dreadful.&#xD;
= worse possible&#xD;
= unbearable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients Satisfaction with procedure</measure>
    <time_frame>witthin 45 minutes of the procedure</time_frame>
    <description>Satisfaction with the procedure based on Likert scale. The scale is from 1 to 5.&#xD;
= Very dissatisfied.&#xD;
= Dissatisfied..&#xD;
= Neither satisfied nor dissatisfied.&#xD;
= Satisfied.&#xD;
= Very satisfied.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15g of Topical Xylocaine gel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>15g of KY Jelly</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Gel</intervention_name>
    <description>topical lidocaine gel</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KY jelly</intervention_name>
    <description>topical KY jelly</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All women that are sent in to the department of radiology for Hysterosalpingogram as&#xD;
             part of evaluation for infertility that give consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women that present for hysterosalpingography for other indications apart from&#xD;
             infertility and those that have history of allergy to xylocaine and/or K-Y jelly.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>based on biological gender</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anisah Yahya, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ahmadu Bello University Zaria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahmadu Bello University Teaching Hospital Shika-Zaria</name>
      <address>
        <city>Zaria</city>
        <state>Kaduna</state>
        <zip>PMB 06</zip>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>August 14, 2020</last_update_submitted>
  <last_update_submitted_qc>August 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ahmadu Bello University Teaching Hospital</investigator_affiliation>
    <investigator_full_name>Anisah Yahya</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>infertility</keyword>
  <keyword>hysterosalpingography</keyword>
  <keyword>pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>obtained data and result will be shared</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>within 6 months of completion</ipd_time_frame>
    <ipd_access_criteria>free</ipd_access_criteria>
  </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/NCT03802032
org study id: Ahmadu Bello University
nct id: NCT03802032
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will involve giving topical analgesia or placebo and then assessing pain and
      satisfaction during and after the procedure in order to see wed to the placebo.hether the
      topical analgesia has helped in decreasing pain associated with the procedure and also
      whether it has increasedd satisfaction with the procedure compar
STUDY DESIGN:

      The study will be a double blind randomized controlled trial. Group A:The study group will be
      given topical Xylocaine (2% Lidocaine) before the procedure.

      Group B:The control group will be given topical K-Y jelly (water based lubricant) before the
      procedure.

      The participants and the radiologist will be blinded at the point of drug administration.

      SAMPLE SIZE DETERMINATION:

      The formula below was used to calculate the sample size n= (Zα + Zβ)2S2 d2

      Assuming a difference in mean pain score among groups of 1.5 and using a standard deviation
      of of 3.15.

      Zα = standard normal deviate. Zβ = power = 95% = 1.64. S = standard deviation = 3.1. D = mean
      difference in pain score = 1.5 n = (1.96 + 1.64)2 x 3.12 1.52

      n = 55 Sample size per group will be rounded up to 60

      SAMPLING APPROACH:

      A probability sampling method will be used. Simple random sampling using a computer generated
      table of random numbers will be used. The WINPEPI version 11.65 software will generate the
      table of random numbers. The numbers 001-140 will be randomly allocated to two groups A and
      B. Group A will be the study group and group B will be the control group (see appendix). Each
      number from the table of random numbers will be copied on separate paper and then sealed in a
      brown envelope. The envelopes will then be kept inside a box after shuffling.

      Each patient will be allocated to the group that the number she picks corresponds to on the
      computer printout. The numbers were made up to 140 to make up for patients that may
      eventually drop out from the study.

      .

      SAMPLING RECRUITEMENT:

      Women that fulfil the inclusion criteria will be recruited from radiology department as they
      present for Hysterosalpingogram. After obtaining a written consent, participants will be
      requested to pick one of the brown envelopes which will contain the randomization group.

      BLINDING The drugs to be used (K-Y Jelly and Xylocaine gel) are identical.

      DATA COLLECTION METHOD:

      An informed written consent will be obtained from participants. Psychological support will be
      given to the participant by a nurse after the procedure has been explained to the
      participant. A questionnaire will then be filled. The participant will then be requested to
      pick an envelope that represents the study number. A detailed explanation about the VAS and
      its application was given personally to each woman before the procedure. An interviewer
      administered questionnaire will be used to obtain information on socio-demographic
      characteristics, reproductive profile, previous history of the procedure and experience with
      analgesia.

      The analgesic or placebo will be applied to the cervix (15ml) using a vaginal applicator 10
      minutes before the procedure.

      The procedure will then be done using standard clinical protocol. The pain rating scale will
      be used to evaluate pain during from zero (no pain) to ten (worst possible pain) will be
      explained to the client. The visual scale comparison to happy, glum, sad and horrified faces
      will also be explained to the patient.

      Pain assessment will be done during the procedure at the following steps:

        1. After application of speculum.

        2. After cervical manipulation (application of tenaculum and catheter).

        3. After filling the uterus with contrast medium.

        4. After withdrawal of speculum and catheter.

        5. Thirty minutes after completing the procedure.

      The Likert scale will be used to assess patient satisfaction following pain management.

      .
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomised controlled trial
primary purpose: Treatment
masking: Single (Care Provider)
masking description: Double blind
measure: Pain perception
time frame: witthin 45 minutes of the procedure
description: The pain score based on visual pain scale that assesses pain perception. It is a scale of 0 to 10.
0 = absence of pain.
= discomfort
= mild pain.
= annoying pain.
= nagging pain.
= distressing pain.
= miserable.
= intense
= Dreadful.
= worse possible
= unbearable
measure: Patients Satisfaction with procedure
time frame: witthin 45 minutes of the procedure
description: Satisfaction with the procedure based on Likert scale. The scale is from 1 to 5.
= Very dissatisfied.
= Dissatisfied..
= Neither satisfied nor dissatisfied.
= Satisfied.
= Very satisfied.
arm group label: Study Group
arm group type: Experimental
description: 15g of Topical Xylocaine gel
arm group label: Control group
arm group type: Placebo Comparator
description: 15g of KY Jelly
intervention type: Drug
intervention name: Lidocaine Gel
description: topical lidocaine gel
arm group label: Study Group
intervention type: Drug
intervention name: KY jelly
description: topical KY jelly
arm group label: Control group
criteria: 
gender: Female
gender based: Yes
gender description: based on biological gender
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anisah Yahya, MBBS
role: Principal Investigator
affiliation: Ahmadu Bello University Zaria
facility: 
country: Nigeria
responsible party type: Principal Investigator
investigator affiliation: Ahmadu Bello University Teaching Hospital
investigator full name: Anisah Yahya
investigator title: Doctor
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Lidocaine
sharing ipd: Yes
ipd description: obtained data and result will be shared
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: within 6 months of completion
ipd access criteria: free