[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hysterotomy-affecting-fetus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hysterotomy-affecting-fetus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":21,"type":22},108,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Hysterotomy; Affecting Fetus","RECRUITING","2026-06-04",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":33},"2025-09-16",{"date":37,"type":22},"2029-09-01",{"name":39,"class":40},"University Hospital, Rouen","OTHER",2]