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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pudendal block | Active Comparator | 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. |
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| the standard method | Other | Operated and anesthetized patients according to the standard method within the department |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pudendal block | Procedure | general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Contraindication to the pudendal block technique: notably :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathieux CAMBY, MD | Contact | +33149203040 | mathieu.camby@ght-gpne.fr | |
| Sarah ABRAMOWICZ, MD | Contact | +33149203040 | sarah.abramowicz@ght-gpne.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Camby | Recruiting | Montreuil | 93100 | France |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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