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

Raincy Montfermeil Hospital Group

Status: Unknown

Conditions: Reduction in Pain Within 24 Hours of Surgery

Treatments: Procedure: pudendal block

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05058248

CHIM -RIPH2-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 78 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Pudendal block

Active Comparator group

Description:

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.

Treatment:

Procedure: pudendal block

the standard method

Other group

Description:

Operated and anesthetized patients according to the standard method within the department

Treatment:

Procedure: pudendal block