Clinical trial NCT05058248: Evaluation of a Locoregional Anesthesia Protocol by Pudendal Block in Reconstructive Surgery Clitoral
Official title: "Evaluation of a Locoregional Anesthesia Protocol by Pudendal Block in Reconstructive Surgery Clitoral " Pudendal Block in Clitoral Surgery (Pain REparation CLItoris)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reduction in Pain Within 24 Hours of Surgery
Keywords: excision
Reconstructive surgery of the clitoris
sexual health
chronic pain,
The pudendal block nerve endings.
postoperative pain in clitoral surgery
Lead sponsor: Raincy Montfermeil Hospital Group
Sponsor class: NETWORK
First posted: 2021-09-27
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective non-randomized study comparing the group of patients who received general anesthesia and pudendal block in a historical cohort of patients treated by the standard establishment protocol, that is to say under general anesthesia without locoregional anesthesia.
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: decrease in the mean of the self-reported pain scores in the first 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: decrease in pain on the EVN at 2 hours, 6 hours , Day 1 and Day 7 postoperative
timeFrame: 2 hours, 6 hours, Day 1 and Day 7 postoperative
Other outcomes:
Locations:
city: Montreuil
country: France
facility: Camby
Study officials:
References: