Home › Trials › NCT05969457
Clinical trial Recruiting at 2 sites Phase 3 Interventional Ages 18 to 70 Women only

Local anesthetic before the vaginal incision for vNOTES hysterectomy

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

Run by University Hospital, Rouen · NCT05969457 · Data updated 2026-11-12

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.

More Affecting Fetus trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 70 Years
SexWomen only
Enrollment108 (estimated)
SponsorUniversity Hospital, Rouen
Academic / other
Locations2 sites (Le Havre and 1 other locations)
StatusRecruiting
StartedSeptember 16, 2025
Main results expectedSeptember 1, 2029
Study endsSeptember 1, 2029
Registry record updatedJune 8, 2026
Trial IDNCT05969457 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Gh Le Havre
    Le Havre, France     Recruiting
  • Chu Rouen
    Rouen, France     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Affecting Fetus 2University Hospital, Rouen 66
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.