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

NCT05058248 | Unknown

• 1 other identifier: CHIM -RIPH2-001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• decrease in pain on the EVN at 2 hours, 6 hours , Day 1 and Day 7 postoperative

  2 hours, 6 hours, Day 1 and Day 7 postoperative

Study Arms (2)

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.

Procedure: pudendal block

the standard method

OTHER

Operated and anesthetized patients according to the standard method within the department

Procedure: pudendal block

Interventions

pudendal block PROCEDURE

general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco

Also known as: standard method

Pudendal block; the standard method

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major patient,
• With the indication of a clitoral repair surgery
• Having expressed their free and informed written consent
• Affiliated with a social security scheme

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Raincy Montfermeil Hospital Group: lead

Study Sites (1)

Camby

Montreuil, 93100, France

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mathieux CAMBY, MD

CONTACT

+33149203040; mathieu.camby@ght-gpne.fr

Sarah ABRAMOWICZ, MD

CONTACT

+33149203040; sarah.abramowicz@ght-gpne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 27, 2021
• Study Start: October 14, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: March 14, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)