About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Suspicion of malignant pathology
History of rectal surgery
History of pelvic inflammatory disease
Suspicion of recto-vaginal endometriosis
Trial design
Parallel
Treatments tested in this trial
Naropeine
DrugLocal anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg)
questionnaires
Other interventionNumerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4
Placebo
Other interventionInjection of 20 mL of NaCl
Treatment groups
Trial outcomes
Primary outcomes
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
Sponsors and contacts
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University Hospital, Rouen
Lead sponsor
Groupe Hospitalier du Havre
Collaborator