跳至主要内容
临床试验/NCT05058248
NCT05058248Unknown不适用

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

Raincy Montfermeil Hospital Group2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年10月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
78
试验地点
2
主要终点
decrease in the mean of the self-reported pain scores in the first 24 hours

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

decrease in the mean of the self-reported pain scores in the first 24 hours

时间窗: 24 hours

decrease in the mean of the self-reported pain scores in the first 24 hours using a Numerical visual scale

次要结局

  • 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)

研究者

发起方
Raincy Montfermeil Hospital Group
申办方类型
Network
责任方
Sponsor

研究点 (2)

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