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

Last updated: February 25, 2022
Sponsor: Raincy Montfermeil Hospital Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05058248
CHIM -RIPH2-001
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 practiceproposed experimental

Study Design

Total Participants: 78
Study Start date:
October 14, 2021
Estimated Completion Date:
January 31, 2023

Study 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

Connect with a study center

  • Camby

    Montreuil, 93100
    France

    Active - Recruiting

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