<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/NCT04433611</url>
  </required_header>
  <id_info>
    <org_study_id># 0189-19</org_study_id>
    <nct_id>NCT04433611</nct_id>
  </id_info>
  <brief_title>Efficacy of Uterine Lidocaine Flushing in HyFoSy</brief_title>
  <official_title>Analgesic Efficacy of Intrauterine Lidocaine Flushing in Hysterosalpingo-foam Sonography: A Double-blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assaf-Harofeh Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assaf-Harofeh Medical Center</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>
      To evaluate the efficacy of flushing the uterine cavity with lidocaine before&#xD;
      Hysterosalpingo-Foam Sonography (HyFoSy) to reduce procedure-related pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, double-blind, placebo-controlled trial was approved by the institutional&#xD;
      ethics committee (# 0189-19; approval 22-09-2019) and written informed consent was obtained&#xD;
      from all participants. The sample was composed of women who were referred for tubal patency&#xD;
      evaluation as part of their fertility workup. Exclusion criteria were a known allergy to&#xD;
      lidocaine, unprotected intercourse, profuse vaginal bleeding and genital tract inflammation&#xD;
      or infections (e.g. pelvic inflammatory disease (PID) or suspected sexually transmitted&#xD;
      diseases (purulent vaginal discharge upon speculum insertion), salpingitis or tubo-ovarian&#xD;
      abscess), psychological or neurological lesions affecting sensation, prior cervical surgery,&#xD;
      cervical stenosis.&#xD;
&#xD;
      Randomization took place on the day of the procedure so that the staff had sufficient time to&#xD;
      prepare the instruments and the medication/placebo. Women were randomized into one of two&#xD;
      groups in a 1:1 ratio, using a predetermined randomization code, prepared by a research&#xD;
      nurse. They were allocated to receive either: (1) an intrauterine infusion of 2% lidocaine&#xD;
      (Rafa laboratories, Israel) ('lidocaine flushing' group), or (2) an intrauterine infusion of&#xD;
      0.9 % normal saline (placebo group) just prior to HyFoSy.&#xD;
&#xD;
      An assigned nurse prepared the medications according to the allocation group. Lidocaine and&#xD;
      normal saline were placed in identical 10-mL disposable syringes. The lidocaine solution as&#xD;
      well as the normal saline were both colorless and thus indistinguishable by the women and the&#xD;
      performing sonographer, all of whom were blind to the group assignment.&#xD;
&#xD;
      No form of premedication was given before HyFoSy. The exam was performed after complete&#xD;
      cessation of menstrual bleeding and before the 14th day of the ovulatory cycle. The women&#xD;
      were placed in the supine position on an examination couch and a baseline transvaginal scan&#xD;
      was performed by one of two experienced clinicians to detect any pelvic pathologies. A&#xD;
      vaginal speculum was introduced into the vagina for visualization of the cervix. The cervix&#xD;
      and vagina were cleansed with iodine solution. A balloon-less GIS catheter (GynaecologIQ)19&#xD;
      with a soft tapered tip was inserted into the endocervical canal for all HyFoSy procedures.&#xD;
      The use of a tenaculum for uterine traction or a cervical dilatator to introduce the catheter&#xD;
      was avoided in all cases. The speculum was then removed, taking care not to dislodge the&#xD;
      catheter, and the ultrasound transducer was introduced vaginally. The abovementioned phase of&#xD;
      the exam was performed by the same physician in all cases. The un-labelled solution (2%&#xD;
      lidocaine solution or normal saline) was instilled slowly into the uterine cavity through the&#xD;
      catheter until good distension and clear visualization of the uterine cavity was obtained.&#xD;
      The ExEm® Foam-kit was used to produce foam according to the manufacturer's instructions9.&#xD;
      The foam was then injected slowly via the GIS catheter under direct ultrasound guidance,&#xD;
      until its passage or non-passage through both fallopian tubes had been assessed. All&#xD;
      examinations were performed using a Samsung WS80A ultrasound system equipped with a V5-9 MHz&#xD;
      endovaginal probe.&#xD;
&#xD;
      Pain scores were obtained before the procedure to collect a baseline value and were&#xD;
      reassessed after the HyFoSy examination. All patients were asked to stay for 10-20 min in a&#xD;
      waiting area and were asked to score the level of pain they experienced during the procedure&#xD;
      on a visual analog scale (VAS) as described in20. The VAS consisted of a 10 cm line ranging&#xD;
      from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the&#xD;
      number that represented their perceived level of pain. Based on the VAS scores, the pain&#xD;
      level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).&#xD;
&#xD;
      Sample size was calculated to detect 1 unit of mean difference of pain score between the two&#xD;
      groups using the VAS, assuming that 1 was the SD (standard deviation) within the group.&#xD;
      Twenty-seven women were needed in each group to reject the null hypothesis of 0.05 with a&#xD;
      power of 0.9. Adding 30% to that number to compensate for any missing data gave a number of&#xD;
      39 women in each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analog scale (VAS) pain score</measure>
    <time_frame>22 months</time_frame>
    <description>The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the number that represented their perceived level of pain. Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>To Evaluate the Efficacy of Flushing the Uterine Cavity With Lidocaine Before Hysterosalpingo-Foam Sonography to Reduce Procedure-related Pain</condition>
  <arm_group>
    <arm_group_label>'lidocaine flushing' group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>intrauterine infusion of 0.9 % normal saline (placebo group) just prior to HyFoSy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2% lidocaine</intervention_name>
    <description>intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy&#xD;
The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the number that represented their perceived level of pain. Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).</description>
    <arm_group_label>'lidocaine flushing' group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9 % normal saline</intervention_name>
    <description>intrauterine infusion of 0.9 % normal saline</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        *all women who were referred for tubal patency evaluation as part of their fertility&#xD;
        workup.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known allergy to lidocaine.&#xD;
&#xD;
          -  unprotected intercourse.&#xD;
&#xD;
          -  profuse vaginal bleeding and genital tract inflammation or infections (e.g. pelvic&#xD;
             inflammatory disease (PID).&#xD;
&#xD;
          -  suspected sexually transmitted diseases (purulent vaginal discharge upon speculum&#xD;
             insertion), salpingitis or tubo-ovarian abscess).&#xD;
&#xD;
          -  psychological or neurological lesions affecting sensation, prior cervical surgery,&#xD;
             cervical stenosis.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaakov Melcer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assaf-Harofeh Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yaakov Melcer, MD</last_name>
    <phone>0524551310</phone>
    <email>ymeltcer@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yaakov Melcer</name>
      <address>
        <city>Yavne</city>
        <state>Select A State Or Province</state>
        <zip>8103908</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yaakov Melcer</last_name>
      <phone>0524551310</phone>
      <email>ymeltcer@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>July 26, 2020</last_update_submitted>
  <last_update_submitted_qc>July 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flushing</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_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>1 year</ipd_time_frame>
  </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/NCT04433611
org study id: # 0189-19
nct id: NCT04433611
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the efficacy of flushing the uterine cavity with lidocaine before
      Hysterosalpingo-Foam Sonography (HyFoSy) to reduce procedure-related pain.
This randomized, double-blind, placebo-controlled trial was approved by the institutional
      ethics committee (# 0189-19; approval 22-09-2019) and written informed consent was obtained
      from all participants. The sample was composed of women who were referred for tubal patency
      evaluation as part of their fertility workup. Exclusion criteria were a known allergy to
      lidocaine, unprotected intercourse, profuse vaginal bleeding and genital tract inflammation
      or infections (e.g. pelvic inflammatory disease (PID) or suspected sexually transmitted
      diseases (purulent vaginal discharge upon speculum insertion), salpingitis or tubo-ovarian
      abscess), psychological or neurological lesions affecting sensation, prior cervical surgery,
      cervical stenosis.

      Randomization took place on the day of the procedure so that the staff had sufficient time to
      prepare the instruments and the medication/placebo. Women were randomized into one of two
      groups in a 1:1 ratio, using a predetermined randomization code, prepared by a research
      nurse. They were allocated to receive either: (1) an intrauterine infusion of 2% lidocaine
      (Rafa laboratories, Israel) ('lidocaine flushing' group), or (2) an intrauterine infusion of
      0.9 % normal saline (placebo group) just prior to HyFoSy.

      An assigned nurse prepared the medications according to the allocation group. Lidocaine and
      normal saline were placed in identical 10-mL disposable syringes. The lidocaine solution as
      well as the normal saline were both colorless and thus indistinguishable by the women and the
      performing sonographer, all of whom were blind to the group assignment.

      No form of premedication was given before HyFoSy. The exam was performed after complete
      cessation of menstrual bleeding and before the 14th day of the ovulatory cycle. The women
      were placed in the supine position on an examination couch and a baseline transvaginal scan
      was performed by one of two experienced clinicians to detect any pelvic pathologies. A
      vaginal speculum was introduced into the vagina for visualization of the cervix. The cervix
      and vagina were cleansed with iodine solution. A balloon-less GIS catheter (GynaecologIQ)19
      with a soft tapered tip was inserted into the endocervical canal for all HyFoSy procedures.
      The use of a tenaculum for uterine traction or a cervical dilatator to introduce the catheter
      was avoided in all cases. The speculum was then removed, taking care not to dislodge the
      catheter, and the ultrasound transducer was introduced vaginally. The abovementioned phase of
      the exam was performed by the same physician in all cases. The un-labelled solution (2%
      lidocaine solution or normal saline) was instilled slowly into the uterine cavity through the
      catheter until good distension and clear visualization of the uterine cavity was obtained.
      The ExEm® Foam-kit was used to produce foam according to the manufacturer's instructions9.
      The foam was then injected slowly via the GIS catheter under direct ultrasound guidance,
      until its passage or non-passage through both fallopian tubes had been assessed. All
      examinations were performed using a Samsung WS80A ultrasound system equipped with a V5-9 MHz
      endovaginal probe.

      Pain scores were obtained before the procedure to collect a baseline value and were
      reassessed after the HyFoSy examination. All patients were asked to stay for 10-20 min in a
      waiting area and were asked to score the level of pain they experienced during the procedure
      on a visual analog scale (VAS) as described in20. The VAS consisted of a 10 cm line ranging
      from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the
      number that represented their perceived level of pain. Based on the VAS scores, the pain
      level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).

      Sample size was calculated to detect 1 unit of mean difference of pain score between the two
      groups using the VAS, assuming that 1 was the SD (standard deviation) within the group.
      Twenty-seven women were needed in each group to reject the null hypothesis of 0.05 with a
      power of 0.9. Adding 30% to that number to compensate for any missing data gave a number of
      39 women in each group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: visual analog scale (VAS) pain score
time frame: 22 months
description: The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the number that represented their perceived level of pain. Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).
arm group label: 'lidocaine flushing' group
arm group type: Experimental
description: intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy
arm group label: Placebo group
arm group type: Placebo Comparator
description: intrauterine infusion of 0.9 % normal saline (placebo group) just prior to HyFoSy.
intervention type: Drug
intervention name: 2% lidocaine
description: intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy
The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the number that represented their perceived level of pain. Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).
arm group label: 'lidocaine flushing' group
intervention type: Drug
intervention name: 0.9 % normal saline
description: intrauterine infusion of 0.9 % normal saline
arm group label: Placebo group
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yaakov Melcer
role: Principal Investigator
affiliation: Assaf-Harofeh Medical Center
last name: Yaakov Melcer, MD
phone: 0524551310
email: ymeltcer@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Flushing
mesh term: Lidocaine
sharing ipd: Yes
ipd info type: Analytic Code
ipd time frame: 1 year