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

NCT05969457 | Not Yet Recruiting Phase 3

• 1 other identifier: CHU de Rouen
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experienced group

EXPERIMENTAL

Administration of Naropeine

Drug: Naropeine; Other: questionnaires

Control group

PLACEBO COMPARATOR

Administration of a saline solution

Other: questionnaires; Other: Placebo

Interventions

Naropeine DRUG

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

Experienced group

questionnaires OTHER

Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4

Control group; Experienced group

Placebo OTHER

Injection of 20 mL of NaCl

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Groupe Hospitalier du Havre: collaborator

MeSH Terms

Interventions

Ropivacaine; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

David Mallet

CONTACT

02 32 88 82 65; secretariat.DRC@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 1, 2023
• Study Start: May 30, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share