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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Reduction in Pain Within 24 Hours of Surgery
• Intervention / Treatment: Procedure: pudendal block

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

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathieux CAMBY, MD; Phone Number: +33149203040; Email: mathieu.camby@ght-gpne.fr
• Study Contact Backup: Name: Sarah ABRAMOWICZ, MD; Phone Number: +33149203040; Email: sarah.abramowicz@ght-gpne.fr

Study Locations

• France
  • Montreuil, France, 93100
    • Recruiting
    • Camby
    • Contact: Mathieu CAMBY; Email: mathieu.camby@ght-gpne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Pudendal block; 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; general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco; Other Names: standard method
OTHER: the standard method; Operated and anesthetized patients according to the standard method within the department	Procedure: pudendal block; general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco; Other Names: standard method

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Raincy Montfermeil Hospital Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2021
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (ACTUAL): September 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: sexual health; excision; Reconstructive surgery of the clitoris; chronic pain,; The pudendal block nerve endings.; postoperative pain in clitoral surgery
• Other Study ID Numbers: CHIM -RIPH2-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No