Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
- Conditions
- Hysterotomy; Affecting Fetus
- Interventions
- Other: questionnairesDrug: NaropeineOther: Placebo
- Registration Number
- NCT05969457
- Lead Sponsor
- University Hospital, Rouen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 108
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group questionnaires Administration of a saline solution Control group Placebo Administration of a saline solution Experienced group Naropeine Administration of Naropeine Experienced group questionnaires Administration of Naropeine
- Primary Outcome Measures
Name Time Method pain after surgery 4hours after surgery Pain will be assessed by the post-operative hospital nurse using a numerical rating scale (NRS) NRS score from 1 to 10 -\> 10 correspoding to the worst pain
- Secondary Outcome Measures
Name Time Method