Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Naropeine, questionnaires, Placebo.
- Who it may be relevant to
- Registry conditions: Hysterotomy; Affecting Fetus. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study
Overview
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.
Interventions
- Drug Naropeine
Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg) - Other questionnaires
Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4 - Other Placebo
Injection of 20 mL of NaCl
Primary outcome measures
- pain after surgery [Time frame: 4hours after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
France · 2 centers
- Gh Le Havre — Le Havre
- Chu Rouen — Rouen
Identifiers
NCT: NCT05969457 · 2022/0270/HP