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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05969457

Acronym

ANOTES

Enrollment

108

Registered

2023-08-01

Start date

2025-09-16

Completion date

2029-09-01

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterotomy; Affecting Fetus

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.

Interventions

DRUGNaropeine

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

OTHERquestionnaires

Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4

OTHERPlacebo

Injection of 20 mL of NaCl

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
pain after surgery	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

Countries

France

Contacts

CONTACTPatrice Crochet, Dr

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026