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ClinicalTrials.gov ID

NCT05969457

Lead Sponsor

University Hospital, RouenOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

108Estimated

Last Update Posted

Jun 8, 2026Actual

Start Date

Sep 16, 2025Actual

Primary Completion Date

Sep 1, 2029Estimated

Completion Date

Sep 1, 2029Estimated

Official Title

Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study

Brief Summary

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.

• Hysterotomy; Affecting Fetus

• Naropeine
• questionnaires
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

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.

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

University Hospital, RouenOTHER

Collaborators

Groupe Hospitalier du HavreOTHER

Patrice.Crochet@chu-rouen.fr06 88 38 48 03 ext. +33