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Can a simple injection before hysterectomy ease Post-Op pain?

NCT ID NCT05969457

Symptom relief Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether injecting a local anesthetic (ropivacaine) into the vagina before making the incision for a hysterectomy can reduce pain after surgery. 108 women scheduled for vaginal hysterectomy will be randomly assigned to receive either the anesthetic or a placebo (salt water) while under general anesthesia. The main goal is to see if the anesthetic group reports less pain in the hours after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ropivacaine (a local anesthetic)
What this could lead to
If it works, this could provide a simple way to reduce post-surgery pain for women undergoing vaginal hysterectomy.
What could go wrong
This is a relatively small, early-phase trial. The benefit may be small or not apply to all patients. There is always a risk of side effects from the anesthetic.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hysterotomy; affecting fetus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chu Rouen

    RECRUITING

    Rouen, 76031, France

  • Gh Le Havre

    RECRUITING

    Le Havre, 76083, France