[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513744":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":24,"interventions":38,"overallOfficials":13,"centralContacts":52,"locations":59,"responsibleParty":95,"collaborators":97,"id":100,"slug":13,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":13,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":13,"overallStatus":62,"whyStopped":13,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University Hospital, Rouen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"pain after surgery","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","4hours after surgery",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":19,"maskingDescription":13,"whoMasked":20},"TRIPLE",[21,22,23],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[25,32],{"label":26,"type":27,"description":28,"interventionNames":29},"Experienced group","EXPERIMENTAL","Administration of Naropeine",[30,31],"Drug: Naropeine","Other: questionnaires",{"label":33,"type":34,"description":35,"interventionNames":36},"Control group","PLACEBO_COMPARATOR","Administration of a saline solution",[31,37],"Other: Placebo",[39,44,48],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":13},"DRUG","Naropeine","Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg\u002FmL, i.e. 150mg)",[26],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":13},"questionnaires","Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4",[33,26],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":13},"Placebo","Injection of 20 mL of NaCl",[33],[53],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Patrice Crochet, Dr","CONTACT","06 88 38 48 03","+33","Patrice.Crochet@chu-rouen.fr",[60,80],{"facility":61,"status":62,"city":63,"state":13,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Gh Le Havre","RECRUITING","Le Havre","76083","France","FR",{"type":68,"coordinates":69},"Point",[70,71],0.10785,49.49346,{"lat":71,"lon":70},[74,78],{"name":75,"role":55,"phone":76,"phoneExt":13,"email":77},"Anthony Feraille, Dr","02 32 73 32 32","Anthony.feraille@ch-havre.fr",{"name":75,"role":79,"phone":13,"phoneExt":13,"email":13},"PRINCIPAL_INVESTIGATOR",{"facility":81,"status":62,"city":82,"state":13,"zip":83,"country":65,"countryCode":66,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Chu Rouen","Rouen","76031",{"type":68,"coordinates":85},[86,87],1.09932,49.44313,{"lat":87,"lon":86},[90,91,93],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},{"name":92,"role":79,"phone":13,"phoneExt":13,"email":13},"Morgane Perrin, Dr",{"name":54,"role":94,"phone":13,"phoneExt":13,"email":13},"SUB_INVESTIGATOR",{"type":96,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[98],{"name":99,"class":6},"Groupe Hospitalier du Havre","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":111,"type":112},108,"ESTIMATED","INTERVENTIONAL",[115],"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.",[118],"Hysterotomy; Affecting Fetus","2026-06-04",{"date":121,"type":122},"2026-06-08","ACTUAL",{"date":124,"type":122},"2025-09-16",{"date":126,"type":112},"2029-09-01",{"name":5,"class":6},2]