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Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach

NCT05969457

RecruitingPhase 3

Sponsor: University Hospital, Rouen

Conditions: Hysterotomy; Affecting Fetus

Interventions: Naropeine, questionnaires, Placebo

Countries: France

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult patients aged 18 to 70 inclusive
* 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)).
* Person having read and understood the information letter and signed the consent form
* Person affiliated to a social security scheme

Exclusion Criteria:

* Suspicion of malignant pathology
* History of rectal surgery
* History of pelvic inflammatory disease
* Suspicion of recto-vaginal endometriosis
* Virginity
* Contraindication to NAROPEINE 7.5 mg/mL, solution for injection in ampoule
* Contraindication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection
* Patients on a low-salt diet
* History of more than 2 caesarean sections
* 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
* BMI \> 35
* Contraindication to analgesic molecules in intraoperative and postoperative protocols.

Locations (2)

Le Havre, France
Rouen, France