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

RecruitingPhase 3Ages 18 Years - 70 YearsFemaleUniversity Hospital, Rouen
NCT05969457 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Naropeine
  • questionnaires
  • Placebo
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Where

2 sites
Gh Le Havre
Le Havre, France
Chu Rouen
Rouen, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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