Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05969457

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hysterotomy; Affecting Fetus

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Gh Le Havre, Le Havre, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naropeine

Drug

Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg)

questionnaires

Other

Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4

Placebo

Other

Injection of 20 mL of NaCl

Primary outcomes

  1. pain after surgery

    Time frame: 4hours after surgery

    Pain will be assessed by the post-operative hospital nurse using a numerical rating scale (NRS) NRS score from 1 to 10 -> 10 correspoding to the worst pain

Study contacts

Contact information is provided by the study sponsor or research team.

Patrice Crochet, Dr

CONTACT

[email protected]

06 88 38 48 03 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • Groupe Hospitalier du Havre

Registry information

Official study title

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

Acronym: ANOTES

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 1, 2023
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.