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

NCT ID: NCT05969457

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2027-10-01

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.

Conditions

Hysterotomy; Affecting Fetus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Experienced group

Administration of Naropeine

Group Type: EXPERIMENTAL

Naropeine

Intervention Type: DRUG

Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg)

questionnaires

Intervention Type: OTHER

Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4

Control group

Administration of a saline solution

Group Type: PLACEBO_COMPARATOR

questionnaires

Intervention Type: OTHER

Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4

Placebo

Intervention Type: OTHER

Injection of 20 mL of NaCl

Interventions

Naropeine

Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg)

Intervention Type: DRUG

questionnaires

Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4

Intervention Type: OTHER

Placebo

Injection of 20 mL of NaCl

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier du Havre

OTHER

Sponsor Role: collaborator

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

David Mallet

Role: CONTACT

secretariat.DRC@chu-rouen.fr

02 32 88 82 65 ext. +33

Other Identifiers

CHU de Rouen

Identifier Type: -

Identifier Source: org_study_id