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

Study acronym: ANOTES
StatusRecruiting
PhasePhase 3
Started2025-09-16
View on ClinicalTrials.gov ↗

Amendment history

2026-06-04
Study Identification, Study Status v3
Re-verified, no change to tracked fields
2026-05-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-10-01→2029-09-01
Completion date2027-10-01→2029-09-01
Start dateestimated 2024-05-30→confirmed 2025-09-16
Study sites0→2
2024-03-29
Study Status v1
Start date2023-10-01→2024-05-30
2023-07-27
Original filing
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.
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