Actively Recruiting
Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
Led by University Hospital, Rouen · Updated on 2026-05-12
108
Participants Needed
2
Research Sites
206 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Rouen
Lead Sponsor
G
Groupe Hospitalier du Havre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 70 inclusive
- Scheduled for vNOTES surgery for total hysterectomy for benign pathology, with or without adnexal procedure
- Have read and understood the information letter and signed the consent form
- Affiliated with a social security scheme
You will not qualify if you...
- Suspicion of malignant pathology
- History of rectal surgery
- History of pelvic inflammatory disease
- Suspicion of recto-vaginal endometriosis
- Virginity
- Contraindication to Ropivacaine 7.5 mg/mL solution for injection
- Contraindication to sodium chloride 0.9% solution for injection
- On a low-salt diet
- History of more than 2 cesarean sections
- Estimated uterine size greater than 700 g based on preoperative imaging
- BMI greater than 35
- Contraindication to analgesic molecules used in intraoperative and postoperative protocols
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Gh Le Havre
Le Havre, France, 76083
Actively Recruiting
2
Chu Rouen
Rouen, France, 76031
Actively Recruiting
Research Team
P
Patrice Crochet, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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