Evaluation of a Locoregional Anesthesia Protocol by Pudendal Block in Reconstructive Surgery Clitoral

Not Applicable

• Conditions: Reduction in Pain Within 24 Hours of Surgery
• Interventions: Procedure: pudendal block

• Registration Number: NCT05058248
• Lead Sponsor: Raincy Montfermeil Hospital Group

Brief Summary

Reconstructive surgery of the clitoris is part of the care offered during a process of care of women victims of MSF. It consists in reconstituting a clitoral neogland after removal of the vulvar excisional scar and recovery of the remaining clitoris. Studies that have monitoring the implementation of this surgery show that it improves the well-being of the patients, brings benefits anatomically, sexual health, personal development, and in the long term decreases chronic pain.

Currently the standard method used in the usual care of the patient is: general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco The pudendal block that the investigators want to evaluate in this research, is a technique that has made proven in several types of surgery, associated with very few complications and easily reproducible.

Detailed Description

Reconstructive surgery of the clitoris is part of the care offered during a process of care of women victims of MSF. It consists in reconstituting a clitoral neogland after removal of the vulvar excisional scar and recovery of the remaining clitoris. Studies that have monitoring the implementation of this surgery show that it improves the well-being of the patients, brings benefits anatomically, sexual health, personal development, and in the long term decreases chronic pain. Currently the standard method used in the usual care of the patient is: general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco The pudendal block that the investigators want to evaluate in this research, is a technique that has made proven in several types of surgery, associated with very few complications and easily reproducible. The human clitoris is the most sensitive organ in the human body, with over 8000 endings nervous. All these endings come from the pudendal nerve, itself most often of nerve roots S3. The main hypothesis is that a bilateral anesthetic block of this nerve would reduce postoperative pain in clitoral surgery

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-27
• Study Start: 2021-10-14
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-03-14
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

• Major patient,
• With the indication of a clitoral repair surgery
• Having expressed their free and informed written consent
• Affiliated with a social security scheme

Exclusion Criteria

• Contraindication to the pudendal block technique: notably :

• blood crass disorder
• allergy to Naropein
• infection at the injection site - Poor understanding of the interest of the practice proposed experimental

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pudendal block	pudendal block	Ultrasound-guided bilateral pudendal block at the start of surgery, in gynecological position: injection of 15 mL of 0.475% Naropein in each ischiorectal fossa.
the standard method	pudendal block	Operated and anesthetized patients according to the standard method within the department

Primary Outcome Measures

Name	Time	Method
decrease in the mean of the self-reported pain scores in the first 24 hours	24 hours	decrease in the mean of the self-reported pain scores in the first 24 hours using a Numerical visual scale

Secondary Outcome Measures

Name	Time	Method
decrease in pain on the EVN at 2 hours, 6 hours , Day 1 and Day 7 postoperative	2 hours, 6 hours, Day 1 and Day 7 postoperative	decrease in pain on the EVN at 2 hours, 6 hours , Day 1 and Day 7 with the pudental block method

Trial Locations

Locations (1)

Camby; 🇫🇷 Montreuil, France