Status:
NOT_YET_RECRUITING
Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
Lead Sponsor:
University Hospital, Rouen
Collaborating Sponsors:
Groupe Hospitalier du Havre
Conditions:
Hysterotomy; Affecting Fetus
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05969457
Start Date
May 30 2024
End Date
October 1 2027
Last Update
April 1 2024
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