NCT05969457 Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
| NCT ID | NCT05969457 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Rouen |
| Condition | Hysterotomy; Affecting Fetus |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2029-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 108 participants in total. It began in 2025-09-16 with a primary completion date of 2029-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05969457 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Hysterotomy; Affecting Fetus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05969457 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 108 participants.
Is NCT05969457 currently recruiting?
Yes, NCT05969457 is actively recruiting participants. Contact the research team at Patrice.Crochet@chu-rouen.fr for enrollment information.
Where is the NCT05969457 trial being conducted?
This trial is being conducted at Le Havre, France, Rouen, France.
Who is sponsoring the NCT05969457 clinical trial?
NCT05969457 is sponsored by University Hospital, Rouen. The trial plans to enroll 108 participants.