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/NCT05969457</url>
    </required_header>
    <id_info>
      <org_study_id>CHU de Rouen</org_study_id>
      <nct_id>NCT05969457</nct_id>
    </id_info>
    <brief_title>Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach</brief_title>
    <acronym>ANOTES</acronym>
    <official_title>Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Rouen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Groupe Hospitalier du Havre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Rouen</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 research procedure is the injection of 20 mL of Ropivacaine solution (vs. saline) to&#xD;
        create a paracervical block at the beginning of surgery, while the patient is already under&#xD;
        general anesthesia.&#xD;
  &#xD;
        This injection will take place 3 minutes before the vaginal incision, via 4 injection points.&#xD;
        Injections are made 3 mm deep into the vaginal cul de sac.&#xD;
  &#xD;
        Randomization takes place before surgery by vNOTES:&#xD;
  &#xD;
          -  Experienced group: Local anesthesia with injection of Ropivacaine (20mL of ropivacaine&#xD;
             7.5 mg/mL, i.e. 150mg) and general anesthesia&#xD;
  &#xD;
          -  Control group: Injection of 20mL of placebo (saline) and general anesthesia&#xD;
  &#xD;
        In both groups, systematic intraoperative and postoperative analgesia will be identical.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2027</primary_completion_date>
    <phase>Phase 3</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>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>pain after surgery</measure>
      <time_frame>4hours after surgery</time_frame>
      <description>Pain will be assessed by the post-operative hospital nurse using a numerical rating scale (NRS) NRS score from 1 to 10 -&gt; 10 correspoding to the worst pain</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">108</enrollment>
    <condition>Hysterotomy; Affecting Fetus</condition>
    <arm_group>
      <arm_group_label>Experienced group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administration of Naropeine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Administration of a saline solution</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Naropeine</intervention_name>
      <description>Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg)</description>
      <arm_group_label>Experienced group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>questionnaires</intervention_name>
      <description>Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Experienced group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Injection of 20 mL of NaCl</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients aged 18 to 70 inclusive&#xD;
  &#xD;
            -  Patient scheduled for vNOTES surgery for total hysterectomy for benign pathology,&#xD;
               whether or not associated with an adnexal procedure (unilateral or bilateral&#xD;
               salpingectomy or adnexectomy (for cysts smaller than 6 cm)).&#xD;
  &#xD;
            -  Person having read and understood the information letter and signed the consent form&#xD;
  &#xD;
            -  Person affiliated to a social security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Suspicion of malignant pathology&#xD;
  &#xD;
            -  History of rectal surgery&#xD;
  &#xD;
            -  History of pelvic inflammatory disease&#xD;
  &#xD;
            -  Suspicion of recto-vaginal endometriosis&#xD;
  &#xD;
            -  Virginity&#xD;
  &#xD;
            -  Contraindication to NAROPEINE 7.5 mg/mL, solution for injection in ampoule&#xD;
  &#xD;
            -  Contraindication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection&#xD;
  &#xD;
            -  Patients on a low-salt diet&#xD;
  &#xD;
            -  History of more than 2 caesarean sections&#xD;
  &#xD;
            -  Estimated uterine size &gt; 700 g according to the following formula y = 0.35x + 107 (x =&#xD;
               a × b × c), based on measurements taken on preoperative imaging (MRI or ultrasound).&#xD;
               a=longitudinal diameter, b=sagital diameter, c=transverse diameter.3&#xD;
  &#xD;
            -  BMI &gt; 35&#xD;
  &#xD;
            -  Contraindication to analgesic molecules in intraoperative and postoperative protocols.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Women</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>David Mallet</last_name>
      <phone>02 32 88 82 65</phone>
      <phone_ext>+33</phone_ext>
      <email>secretariat.DRC@chu-rouen.fr</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ropivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05969457
  org study id: CHU de Rouen
  nct id: NCT05969457
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The research procedure is the injection of 20 mL of Ropivacaine solution (vs. saline) to
        create a paracervical block at the beginning of surgery, while the patient is already under
        general anesthesia.
  
        This injection will take place 3 minutes before the vaginal incision, via 4 injection points.
        Injections are made 3 mm deep into the vaginal cul de sac.
  
        Randomization takes place before surgery by vNOTES:
  
          -  Experienced group: Local anesthesia with injection of Ropivacaine (20mL of ropivacaine
             7.5 mg/mL, i.e. 150mg) and general anesthesia
  
          -  Control group: Injection of 20mL of placebo (saline) and general anesthesia
  
        In both groups, systematic intraoperative and postoperative analgesia will be identical.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Care Provider, Investigator)
  measure: pain after surgery
  time frame: 4hours after surgery
  description: Pain will be assessed by the post-operative hospital nurse using a numerical rating scale (NRS) NRS score from 1 to 10 -> 10 correspoding to the worst pain
  arm group label: Experienced group
  arm group type: Experimental
  description: Administration of Naropeine
  arm group label: Control group
  arm group type: Placebo Comparator
  description: Administration of a saline solution
  intervention type: Drug
  intervention name: Naropeine
  description: Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg)
  arm group label: Experienced group
  intervention type: Other
  intervention name: questionnaires
  description: Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4
  arm group label: Control group
  arm group label: Experienced group
  intervention type: Other
  intervention name: Placebo
  description: Injection of 20 mL of NaCl
  arm group label: Control group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Women
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: David Mallet
  phone: 02 32 88 82 65
  phone ext: +33
  email: secretariat.DRC@chu-rouen.fr
  responsible party type: Sponsor
  mesh term: Ropivacaine
  sharing ipd: No