[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513744":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":43,"responsibleParty":79,"collaborators":81,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":27,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":27,"overallStatus":46,"whyStopped":27,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University Hospital, Rouen","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experienced group","EXPERIMENTAL","Administration of Naropeine",[13,14],"Drug: Naropeine","Other: questionnaires",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","PLACEBO_COMPARATOR","Administration of a saline solution",[14,20],"Other: Placebo",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Naropeine","Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg\u002FmL, i.e. 150mg)",[9],null,{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"questionnaires","Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4",[16,9],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Placebo","Injection of 20 mL of NaCl",[16],[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Patrice Crochet, Dr","CONTACT","06 88 38 48 03","+33","Patrice.Crochet@chu-rouen.fr",[44,64],{"facility":45,"status":46,"city":47,"state":27,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Gh Le Havre","RECRUITING","Le Havre","76083","France","FR",{"type":52,"coordinates":53},"Point",[54,55],0.10785,49.49346,{"lat":55,"lon":54},[58,62],{"name":59,"role":39,"phone":60,"phoneExt":27,"email":61},"Anthony Feraille, Dr","02 32 73 32 32","Anthony.feraille@ch-havre.fr",{"name":59,"role":63,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"facility":65,"status":46,"city":66,"state":27,"zip":67,"country":49,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Chu Rouen","Rouen","76031",{"type":52,"coordinates":69},[70,71],1.09932,49.44313,{"lat":71,"lon":70},[74,75,77],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},{"name":76,"role":63,"phone":27,"phoneExt":27,"email":27},"Morgane Perrin, Dr",{"name":38,"role":78,"phone":27,"phoneExt":27,"email":27},"SUB_INVESTIGATOR",{"type":80,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[82],{"name":83,"class":6},"Groupe Hospitalier du Havre","100513744","phase-3-effect-of-preventive-analgesia-by-injection-of-a-local-anesthetic-before-vaginal-incision-for-hysterectomy-by-vnotes-approach-100513744",false,"NCT05969457","Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach","Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study","ANOTES","Inclusion Criteria:\n\n* Adult patients aged 18 to 70 inclusive\n* Patient scheduled for vNOTES surgery for total hysterectomy for benign pathology, whether or not associated with an adnexal procedure (unilateral or bilateral salpingectomy or adnexectomy (for cysts smaller than 6 cm)).\n* Person having read and understood the information letter and signed the consent form\n* Person affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Suspicion of malignant pathology\n* History of rectal surgery\n* History of pelvic inflammatory disease\n* Suspicion of recto-vaginal endometriosis\n* Virginity\n* Contraindication to NAROPEINE 7.5 mg\u002FmL, solution for injection in ampoule\n* Contraindication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection\n* Patients on a low-salt diet\n* History of more than 2 caesarean sections\n* Estimated uterine size \\> 700 g according to the following formula y = 0.35x + 107 (x = a × b × c), based on measurements taken on preoperative imaging (MRI or ultrasound). a=longitudinal diameter, b=sagital diameter, c=transverse diameter.3\n* BMI \\> 35\n* Contraindication to analgesic molecules in intraoperative and postoperative protocols.","FEMALE","18 Years","70 Years",{"count":96,"type":97},108,"ESTIMATED","INTERVENTIONAL",[100],"PHASE3","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.\n\nThis 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.\n\nRandomization takes place before surgery by vNOTES:\n\n* Experienced group: Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg\u002FmL, i.e. 150mg) and general anesthesia\n* Control group: Injection of 20mL of placebo (saline) and general anesthesia\n\nIn both groups, systematic intraoperative and postoperative analgesia will be identical.",[103],"Hysterotomy; Affecting Fetus","2026-06-04",{"date":106,"type":107},"2026-06-08","ACTUAL",{"date":109,"type":107},"2025-09-16",{"date":111,"type":97},"2029-09-01",{"name":5,"class":6},2]