Local anesthetic before the vaginal incision for vNOTES hysterectomy

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

This trial will test whether a single paracervical injection of ropivacaine given before the vaginal incision reduces pain for adults having vNOTES total hysterectomy for benign conditions.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 2 sites (Le Havre and 1 other locations)
• Trial ID: NCT05969457 on ClinicalTrials.gov

What this trial studies

Participants are randomized to receive either 20 mL ropivacaine (7.5 mg/mL, 150 mg) or 20 mL saline injected at four paracervical points 3 mm deep into the vaginal cul-de-sac three minutes before the vaginal incision while under general anesthesia. The procedure is performed for total hysterectomy by the vNOTES approach, and intraoperative and postoperative analgesic protocols are identical between groups. This is a Phase 3 interventional trial conducted at two French university hospital centers with standard randomized allocation prior to surgery. The study will compare postoperative pain and analgesic use between the ropivacaine and placebo groups to determine if the preventive block reduces pain after vNOTES hysterectomy.

Who should consider this trial

Good fit: Adults aged 18–70 scheduled for vNOTES total hysterectomy for benign disease who can consent and meet the inclusion criteria are the intended participants.

Not a fit: Patients who meet exclusion criteria—such as suspected malignancy, prior rectal surgery or pelvic inflammatory disease, rectovaginal endometriosis, virginity, contraindications to ropivacaine or saline, a low-salt diet, more than two prior cesareans, or an estimated uterine size over 700 g—would not be expected to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, patients could experience less immediate postoperative pain and possibly reduced need for opioid analgesics after vNOTES hysterectomy.

How similar studies have performed: Paracervical blocks and local anesthetic infiltration have reduced pain in other vaginal and gynecologic procedures, but applying this specific preventive block for vNOTES hysterectomy is relatively novel and has not been widely tested in large Phase 3 trials.

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.

Where this trial is running

Le Havre and 1 other locations

• Gh Le Havre — Le Havre, France (Recruiting)
• Chu Rouen — Rouen, France (Recruiting)

Study contacts

• Study coordinator: Patrice Crochet, Dr

Conditions Hysterotomy; Affecting Fetus