xml: <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/NCT05967936</url>
    </required_header>
    <id_info>
      <org_study_id>MP-12-2023-3238</org_study_id>
      <nct_id>NCT05967936</nct_id>
    </id_info>
    <brief_title>Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy</brief_title>
    <official_title>A Prospective Randomized Study Comparing Different Types of Local Anesthesia in Outpatient Procedural Hysteroscopy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ciusss de L'Est de l'Île de Montréal</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ciusss de L'Est de l'Île de Montréal</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Hysteroscopy is a minimally invasive, diagnostic and therapeutic gynecological surgical&#xD;
        technique and the gold standard in the study of the uterine cavity. Thanks to the decrease in&#xD;
        the diameter of hysteroscopes and to the vaginoscopic approach, anesthesia is no longer&#xD;
        necessary in diagnostic hysteroscopy. Nevertheless, in operative hysteroscopy, given the&#xD;
        instrumentalization and the need of cervical dilation, the use of local anesthesia, with or&#xD;
        without sedation, is recommended. The different alternatives described in the literature are&#xD;
        the following:&#xD;
  &#xD;
          1. Cervical/ intracervical block: injection of local anesthetic into the four quadrants of&#xD;
             the cervix.&#xD;
  &#xD;
          2. Paracervical block: injection of local anesthetic in the cervicovaginal junction at 5&#xD;
             and 7 o'clock positions.&#xD;
  &#xD;
          3. Transcervical (uterine) anesthesia: instillation of a local anesthetic agent via&#xD;
             catheter through the cervix and into the uterine cavity.&#xD;
  &#xD;
          4. Topical cervical anesthesia: application of local anesthetic in gel or spray to the&#xD;
             cervix.&#xD;
  &#xD;
        To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the&#xD;
        investigators will perform a prospective multicentric study that compare two types of local&#xD;
        anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual&#xD;
        gold-standard, and transcervical instillation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the&#xD;
        investigators will perform a multicentric prospective randomized trial, single-blinded, that&#xD;
        compares two types of local anesthesia in outpatient procedural hysteroscopy: paracervical&#xD;
        block, that is the actual gold-standard, and transcervical instillation.&#xD;
  &#xD;
        The population studied will consist in adult women with indication of an outpatient surgical&#xD;
        hysteroscopy (myomectomy or polypectomy). Every one of them will be invited to participate&#xD;
        the day of their procedure. In the outpatient hysteroscopy clinic, the investigators will&#xD;
        verify inclusion and exclusion criteria, explain the objectives of the study, collect data&#xD;
        and obtain the patient's consent.&#xD;
  &#xD;
        The sample size is 242 patients (121 in each group). The study will be performed in two&#xD;
        different centers:&#xD;
  &#xD;
          -  Integrated University Health Center and Social Services of the East of the Island of&#xD;
             Montreal&#xD;
  &#xD;
          -  Integrated University Health Center and social services of the South Center of the&#xD;
             Island of Montreal&#xD;
  &#xD;
        Right before each procedure the patients will be randomized through anonymous and alternized&#xD;
        enveloppes that will be distributed in each center, to either receive paracervical or&#xD;
        transcervical anesthesia before hysteroscopy.&#xD;
  &#xD;
        Each patient will receive a pre-established dose of sedative before the procedure, according&#xD;
        to their weight: Fentanyl 0,5 mcg/kg IV and Midazolam 0,02 mg/kg. The subsequent doses will&#xD;
        be noted.&#xD;
  &#xD;
        Under sedation, with the patient in lithotomy position, a medium size speculum will be&#xD;
        inserted. The vagina will be disinfected with chlorhexidine and the anterior lip of the&#xD;
        cervix will be gripped with a Pozzi forceps.&#xD;
  &#xD;
        According to previous randomization, each patient will receive one of the following&#xD;
        alternatives of local anesthesia:&#xD;
  &#xD;
          -  Group A: Paracervical 10cc Bupivacaine 1%, without epinephrine, at 0.5-1 cm depth of the&#xD;
             cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).&#xD;
  &#xD;
          -  Group B: Transcervical (uterine) 10cc Bupivacaine 1% through the endocervix using an&#xD;
             17-Gauge epidural catheter&#xD;
  &#xD;
        During the procedure (T1), the nurse will be in charge to fill the scale (to avoid bias). The&#xD;
        patients will be given a Visual Analogue Scale (VAS) to fill 15 minutes after the procedure&#xD;
        (before discharge), to assess pain.&#xD;
  &#xD;
        For each group the investigators will calculate the average rate of pain according to the&#xD;
        Visual Analogue Scale during and immediately after the procedure (15 minutes). The&#xD;
        investigators will subdivide each group into pre and postmenopausal women and into&#xD;
        nulliparous and parous women and compare their Visual Analogue Scale as well.&#xD;
  &#xD;
        Statistical analysis will be performed to compare results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>Multicentric, prospective, randomized trial, single-blinded, where eligible patients will be randomized to either receive paracervical or transcervical anesthesia before outpatient surgical hysteroscopy</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy</measure>
      <time_frame>during hysteroscopy</time_frame>
      <description>comparing 10 point visual analogue scale (from 0 to 10 points) between two groups of patients recieving Bupivacaine administrated through a paracervical block versus a transcervical block</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy</measure>
      <time_frame>15 minutes post hysteroscopy</time_frame>
      <description>comparing 10 point visual analogue scale (from 0 to 10 points) between two groups of patients recieving Bupivacaine administrated through a paracervical block versus a transcervical block</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients</measure>
      <time_frame>during hysteroscopy</time_frame>
      <description>Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients</measure>
      <time_frame>15 minutes post hysteroscopy</time_frame>
      <description>Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare the pain experience based on the visual analogue scale between nulliparous and parous patients</measure>
      <time_frame>during hysteroscopy</time_frame>
      <description>Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare the pain experience based on the visual analogue scale between nulliparous and parous patients</measure>
      <time_frame>15 minutes post hysteroscopy</time_frame>
      <description>Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the need for an extra intravenous sedative dose.</measure>
      <time_frame>during hysteroscopy</time_frame>
      <description>Number of patients who demand an extra dose of sedative during hysteroscopy</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">242</enrollment>
    <condition>Myoma;Uterus</condition>
    <condition>Polyp Uterus</condition>
    <arm_group>
      <arm_group_label>Paracervical block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>10cc Bupivacaine 1% at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Transcervical block</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10cc Bupivacaine 1% through the endocervix using an 17-gauge epidural catheter</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine Injection</intervention_name>
      <description>evaluation of pain by using two different types of local anesthesia</description>
      <arm_group_label>Paracervical block</arm_group_label>
      <arm_group_label>Transcervical block</arm_group_label>
      <other_name>evaluation of pain by using two different types of local anesthesia</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female patients&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  Indication of outpatient surgical hysteroscopy for polypectomy and myomectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women under 18 years old&#xD;
  &#xD;
            -  Unable to understand how to score a visual analog scale pain score&#xD;
  &#xD;
            -  Hysteroscopy contraindication&#xD;
  &#xD;
            -  Patients with medical history or current status that makes outpatient procedure usafe&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mélissa Roy, MD</last_name>
      <role>Study Director</role>
      <affiliation>OB-GYN</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Janey Fang, MD</last_name>
      <phone>5142513051</phone>
      <email>jfang85@uwo.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chantal Rivard, MD</last_name>
      <phone>5142513051</phone>
      <email>rivardch@videotron.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CIUSSS de l'Est de l'Île de Montréal</name>
        <address>
          <city>Montréal-Est</city>
          <state>Quebec</state>
          <zip>H1T 2M4</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Janey Fang, MD</last_name>
        <phone>5142513051</phone>
        <email>jfang85@uwo.ca</email>
      </contact>
      <contact_backup>
        <last_name>Chantal Rivard, MD</last_name>
        <phone>5142513051</phone>
        <email>rivardch@videotron.ca</email>
      </contact_backup>
      <investigator>
        <last_name>Paz Garcia, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mélissa Roy, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Janey Fang, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Chantal Rivard, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Émilie Hudon, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Émilie Gorak, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mik Gangal, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>Readman E, Maher PJ. Pain relief and outpatient hysteroscopy: a literature review. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):315-9. doi: 10.1016/s1074-3804(05)60042-4.</citation>
      <PMID>15559340</PMID>
    </reference>
    <reference>
      <citation>Lau WC, Tam WH, Lo WK, Yuen PM. A randomised double-blind placebo-controlled trial of transcervical intrauterine local anaesthesia in outpatient hysteroscopy. BJOG. 2000 May;107(5):610-3. doi: 10.1111/j.1471-0528.2000.tb13301.x.</citation>
      <PMID>10826574</PMID>
    </reference>
    <reference>
      <citation>De Silva PM, Mahmud A, Smith PP, Clark TJ. Analgesia for Office Hysteroscopy: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1034-1047. doi: 10.1016/j.jmig.2020.01.008. Epub 2020 Jan 23.</citation>
      <PMID>31982584</PMID>
    </reference>
    <reference>
      <citation>Bettocchi S, Selvaggi L. A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc. 1997 Feb;4(2):255-8. doi: 10.1016/s1074-3804(97)80019-9.</citation>
      <PMID>9050737</PMID>
    </reference>
    <reference>
      <citation>Cicinelli E, Didonna T, Ambrosi G, Schonauer LM, Fiore G, Matteo MG. Topical anaesthesia for diagnostic hysteroscopy and endometrial biopsy in postmenopausal women: a randomised placebo-controlled double-blind study. Br J Obstet Gynaecol. 1997 Mar;104(3):316-9. doi: 10.1111/j.1471-0528.1997.tb11460.x.</citation>
      <PMID>9091008</PMID>
    </reference>
    <reference>
      <citation>Lau WC, Lo WK, Tam WH, Yuen PM. Paracervical anaesthesia in outpatient hysteroscopy: a randomised double-blind placebo-controlled trial. Br J Obstet Gynaecol. 1999 Apr;106(4):356-9. doi: 10.1111/j.1471-0528.1999.tb08274.x.</citation>
      <PMID>10426243</PMID>
    </reference>
    <reference>
      <citation>Zupi E, Luciano AA, Valli E, Marconi D, Maneschi F, Romanini C. The use of topical anesthesia in diagnostic hysteroscopy and endometrial biopsy. Fertil Steril. 1995 Feb;63(2):414-6.</citation>
      <PMID>7843454</PMID>
    </reference>
    <reference>
      <citation>Broadbent JA, Hill NC, Molnar BG, Rolfe KJ, Magos AL. Randomized placebo controlled trial to assess the role of intracervical lignocaine in outpatient hysteroscopy. Br J Obstet Gynaecol. 1992 Sep;99(9):777-9. doi: 10.1111/j.1471-0528.1992.tb13886.x. No abstract available.</citation>
      <PMID>1420022</PMID>
    </reference>
    <reference>
      <citation>Cooper NA, Khan KS, Clark TJ. Local anaesthesia for pain control during outpatient hysteroscopy: systematic review and meta-analysis. BMJ. 2010 Mar 23;340:c1130. doi: 10.1136/bmj.c1130.</citation>
      <PMID>20332307</PMID>
    </reference>
    <reference>
      <citation>Kosus N, Kosus A, Guler A, Simavli SA, Turhan NO. Transcervical intrauterine levobupivacaine infusion or paracervical block for pain control during endometrial biopsy. Exp Ther Med. 2012 Apr;3(4):683-688. doi: 10.3892/etm.2012.463. Epub 2012 Jan 30.</citation>
      <PMID>22969951</PMID>
    </reference>
    <reference>
      <citation>Guida M, Pellicano M, Zullo F, Acunzo G, Lavitola G, Palomba S, Nappi C. Outpatient operative hysteroscopy with bipolar electrode: a prospective multicentre randomized study between local anaesthesia and conscious sedation. Hum Reprod. 2003 Apr;18(4):840-3. doi: 10.1093/humrep/deg075.</citation>
      <PMID>12660281</PMID>
    </reference>
    <reference>
      <citation>Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.</citation>
      <PMID>22588748</PMID>
    </reference>
    <reference>
      <citation>Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.</citation>
      <PMID>3785962</PMID>
    </reference>
    <reference>
      <citation>Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.</citation>
      <PMID>20027030</PMID>
    </reference>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>hysteroscopy</keyword>
    <keyword>pain</keyword>
    <keyword>local anesthetic</keyword>
    <keyword>ambulatory care</keyword>
    <keyword>bupivacaine</keyword>
    <keyword>paracervical block</keyword>
    <keyword>transcervical block</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leiomyoma</mesh_term>
      <mesh_term>Myofibroma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is not a plan to make IPD available</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967936
  org study id: MP-12-2023-3238
  nct id: NCT05967936
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Hysteroscopy is a minimally invasive, diagnostic and therapeutic gynecological surgical
        technique and the gold standard in the study of the uterine cavity. Thanks to the decrease in
        the diameter of hysteroscopes and to the vaginoscopic approach, anesthesia is no longer
        necessary in diagnostic hysteroscopy. Nevertheless, in operative hysteroscopy, given the
        instrumentalization and the need of cervical dilation, the use of local anesthesia, with or
        without sedation, is recommended. The different alternatives described in the literature are
        the following:
  
          1. Cervical/ intracervical block: injection of local anesthetic into the four quadrants of
             the cervix.
  
          2. Paracervical block: injection of local anesthetic in the cervicovaginal junction at 5
             and 7 o'clock positions.
  
          3. Transcervical (uterine) anesthesia: instillation of a local anesthetic agent via
             catheter through the cervix and into the uterine cavity.
  
          4. Topical cervical anesthesia: application of local anesthetic in gel or spray to the
             cervix.
  
        To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the
        investigators will perform a prospective multicentric study that compare two types of local
        anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual
        gold-standard, and transcervical instillation.
  To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the
        investigators will perform a multicentric prospective randomized trial, single-blinded, that
        compares two types of local anesthesia in outpatient procedural hysteroscopy: paracervical
        block, that is the actual gold-standard, and transcervical instillation.
  
        The population studied will consist in adult women with indication of an outpatient surgical
        hysteroscopy (myomectomy or polypectomy). Every one of them will be invited to participate
        the day of their procedure. In the outpatient hysteroscopy clinic, the investigators will
        verify inclusion and exclusion criteria, explain the objectives of the study, collect data
        and obtain the patient's consent.
  
        The sample size is 242 patients (121 in each group). The study will be performed in two
        different centers:
  
          -  Integrated University Health Center and Social Services of the East of the Island of
             Montreal
  
          -  Integrated University Health Center and social services of the South Center of the
             Island of Montreal
  
        Right before each procedure the patients will be randomized through anonymous and alternized
        enveloppes that will be distributed in each center, to either receive paracervical or
        transcervical anesthesia before hysteroscopy.
  
        Each patient will receive a pre-established dose of sedative before the procedure, according
        to their weight: Fentanyl 0,5 mcg/kg IV and Midazolam 0,02 mg/kg. The subsequent doses will
        be noted.
  
        Under sedation, with the patient in lithotomy position, a medium size speculum will be
        inserted. The vagina will be disinfected with chlorhexidine and the anterior lip of the
        cervix will be gripped with a Pozzi forceps.
  
        According to previous randomization, each patient will receive one of the following
        alternatives of local anesthesia:
  
          -  Group A: Paracervical 10cc Bupivacaine 1%, without epinephrine, at 0.5-1 cm depth of the
             cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).
  
          -  Group B: Transcervical (uterine) 10cc Bupivacaine 1% through the endocervix using an
             17-Gauge epidural catheter
  
        During the procedure (T1), the nurse will be in charge to fill the scale (to avoid bias). The
        patients will be given a Visual Analogue Scale (VAS) to fill 15 minutes after the procedure
        (before discharge), to assess pain.
  
        For each group the investigators will calculate the average rate of pain according to the
        Visual Analogue Scale during and immediately after the procedure (15 minutes). The
        investigators will subdivide each group into pre and postmenopausal women and into
        nulliparous and parous women and compare their Visual Analogue Scale as well.
  
        Statistical analysis will be performed to compare results.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Multicentric, prospective, randomized trial, single-blinded, where eligible patients will be randomized to either receive paracervical or transcervical anesthesia before outpatient surgical hysteroscopy
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy
  time frame: during hysteroscopy
  description: comparing 10 point visual analogue scale (from 0 to 10 points) between two groups of patients recieving Bupivacaine administrated through a paracervical block versus a transcervical block
  measure: To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy
  time frame: 15 minutes post hysteroscopy
  description: comparing 10 point visual analogue scale (from 0 to 10 points) between two groups of patients recieving Bupivacaine administrated through a paracervical block versus a transcervical block
  measure: Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients
  time frame: during hysteroscopy
  description: Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients
  measure: Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients
  time frame: 15 minutes post hysteroscopy
  description: Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients
  measure: Compare the pain experience based on the visual analogue scale between nulliparous and parous patients
  time frame: during hysteroscopy
  description: Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients
  measure: Compare the pain experience based on the visual analogue scale between nulliparous and parous patients
  time frame: 15 minutes post hysteroscopy
  description: Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients
  measure: To evaluate the need for an extra intravenous sedative dose.
  time frame: during hysteroscopy
  description: Number of patients who demand an extra dose of sedative during hysteroscopy
  arm group label: Paracervical block
  arm group type: Active Comparator
  description: 10cc Bupivacaine 1% at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).
  arm group label: Transcervical block
  arm group type: Experimental
  description: 10cc Bupivacaine 1% through the endocervix using an 17-gauge epidural catheter
  intervention type: Drug
  intervention name: Bupivacaine Injection
  description: evaluation of pain by using two different types of local anesthesia
  arm group label: Paracervical block
  arm group label: Transcervical block
  other name: evaluation of pain by using two different types of local anesthesia
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mélissa Roy, MD
  role: Study Director
  affiliation: OB-GYN
  last name: Janey Fang, MD
  phone: 5142513051
  email: jfang85@uwo.ca
  last name: Chantal Rivard, MD
  phone: 5142513051
  email: rivardch@videotron.ca
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Canada
  citation: Readman E, Maher PJ. Pain relief and outpatient hysteroscopy: a literature review. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):315-9. doi: 10.1016/s1074-3804(05)60042-4.
  PMID: 15559340
  citation: Lau WC, Tam WH, Lo WK, Yuen PM. A randomised double-blind placebo-controlled trial of transcervical intrauterine local anaesthesia in outpatient hysteroscopy. BJOG. 2000 May;107(5):610-3. doi: 10.1111/j.1471-0528.2000.tb13301.x.
  PMID: 10826574
  citation: De Silva PM, Mahmud A, Smith PP, Clark TJ. Analgesia for Office Hysteroscopy: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1034-1047. doi: 10.1016/j.jmig.2020.01.008. Epub 2020 Jan 23.
  PMID: 31982584
  citation: Bettocchi S, Selvaggi L. A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc. 1997 Feb;4(2):255-8. doi: 10.1016/s1074-3804(97)80019-9.
  PMID: 9050737
  citation: Cicinelli E, Didonna T, Ambrosi G, Schonauer LM, Fiore G, Matteo MG. Topical anaesthesia for diagnostic hysteroscopy and endometrial biopsy in postmenopausal women: a randomised placebo-controlled double-blind study. Br J Obstet Gynaecol. 1997 Mar;104(3):316-9. doi: 10.1111/j.1471-0528.1997.tb11460.x.
  PMID: 9091008
  citation: Lau WC, Lo WK, Tam WH, Yuen PM. Paracervical anaesthesia in outpatient hysteroscopy: a randomised double-blind placebo-controlled trial. Br J Obstet Gynaecol. 1999 Apr;106(4):356-9. doi: 10.1111/j.1471-0528.1999.tb08274.x.
  PMID: 10426243
  citation: Zupi E, Luciano AA, Valli E, Marconi D, Maneschi F, Romanini C. The use of topical anesthesia in diagnostic hysteroscopy and endometrial biopsy. Fertil Steril. 1995 Feb;63(2):414-6.
  PMID: 7843454
  citation: Broadbent JA, Hill NC, Molnar BG, Rolfe KJ, Magos AL. Randomized placebo controlled trial to assess the role of intracervical lignocaine in outpatient hysteroscopy. Br J Obstet Gynaecol. 1992 Sep;99(9):777-9. doi: 10.1111/j.1471-0528.1992.tb13886.x. No abstract available.
  PMID: 1420022
  citation: Cooper NA, Khan KS, Clark TJ. Local anaesthesia for pain control during outpatient hysteroscopy: systematic review and meta-analysis. BMJ. 2010 Mar 23;340:c1130. doi: 10.1136/bmj.c1130.
  PMID: 20332307
  citation: Kosus N, Kosus A, Guler A, Simavli SA, Turhan NO. Transcervical intrauterine levobupivacaine infusion or paracervical block for pain control during endometrial biopsy. Exp Ther Med. 2012 Apr;3(4):683-688. doi: 10.3892/etm.2012.463. Epub 2012 Jan 30.
  PMID: 22969951
  citation: Guida M, Pellicano M, Zullo F, Acunzo G, Lavitola G, Palomba S, Nappi C. Outpatient operative hysteroscopy with bipolar electrode: a prospective multicentre randomized study between local anaesthesia and conscious sedation. Hum Reprod. 2003 Apr;18(4):840-3. doi: 10.1093/humrep/deg075.
  PMID: 12660281
  citation: Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
  PMID: 22588748
  citation: Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
  PMID: 3785962
  citation: Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.
  PMID: 20027030
  responsible party type: Sponsor
  mesh term: Leiomyoma
  mesh term: Myofibroma
  mesh term: Bupivacaine
  sharing ipd: No
  ipd description: There is not a plan to make IPD available