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

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of a Locoregional Anesthesia Protocol by Pudendal Block in Reconstructive Surgery Clitoral  Pudendal Block in Clitoral Surgery (Pain REparation CLItoris)

Conditions
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Reduction in Pain Within 24 Hours of Surgery

Intervention / Treatment
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* Procedure: pudendal block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pudendal block<br>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. | Procedure: pudendal block<br>* general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco<br>* Other names: standard method;|
| Other: the standard method<br>Operated and anesthetized patients according to the standard method within the department | Procedure: pudendal block<br>* general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco<br>* Other names: standard method;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in the mean of the self-reported pain scores in the first 24 hours | decrease in the mean of the self-reported pain scores in the first 24 hours using a Numerical visual scale | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in pain on the EVN at 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 | 2 hours, 6 hours, Day 1 and Day 7 postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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excision, Reconstructive surgery of the clitoris, sexual health, chronic pain,, The pudendal block nerve endings., postoperative pain in clitoral surgery