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

University Hospital, Rouen

Status and phase: Not yet enrolling; Phase 3

Conditions: Hysterotomy; Affecting Fetus

Treatments: Drug: Naropeine; Other: Placebo; Other: questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT05969457

CHU de Rouen

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

108 participants in 2 patient groups, including a placebo group

Experienced group

Experimental group

Description:

Administration of Naropeine

Treatment:

Drug: Naropeine

Other: questionnaires

Control group

Placebo Comparator group

Description:

Administration of a saline solution

Treatment:

Other: questionnaires

Other: Placebo