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

NCT05969457 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Hysterotomy; Affecting Fetus

Interventions

DRUG

Naropeine

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

OTHER

questionnaires

Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4

OTHER

Placebo

Injection of 20 mL of NaCl

Sponsors & Collaborators

  • Groupe Hospitalier du Havre

    collaborator OTHER

  • University Hospital, Rouen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2029-09-01
Completion
2029-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05969457 on ClinicalTrials.gov