Clinical Trial

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

Study acronym: ANOTES
Recruiting Phase 3
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-07-27; most recent amendment 2026-06-04.
Status change: Not Yet Recruiting → Recruiting 2026-05-07
Trial Details
NCT Number NCT05969457
Lead Sponsor University Hospital, Rouen
Collaborators: Groupe Hospitalier du Havre
Conditions Hysterotomy; Affecting Fetus
Enrollment 108 participants
Start Date 2025-09-16
Primary Completion 2029-09-01 (estimated)
Study Completion 2029-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-08