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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study

Conditions
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Hysterotomy; Affecting Fetus

Intervention / Treatment
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* Drug: Naropeine
* Other: questionnaires
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experienced group<br>Administration of Naropeine | Drug: Naropeine<br>* Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg)<br>Other: questionnaires<br>* Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4<br>|
| Placebo Comparator: Control group<br>Administration of a saline solution | Other: questionnaires<br>* Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4<br>Other: Placebo<br>* Injection of 20 mL of NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain 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 | 4hours after surgery |