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临床试验/NCT06021782
NCT06021782招募中不适用

Characterization of the Pudendal Nerve with Transvaginal Ultrasonography

University of Virginia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Observing the Pudendal Nerve

研究概览

简要总结

This is a feasibility study characterizing the ability of transvaginal ultrasonography to identify the pudendal nerve. Today, the pudendal nerve block is typically accomplished through blind landmark techniques, thus limiting its success. To date, there has never been an attempt to determine if the visualization of the pudendal nerve would be possible using transvaginal ultrasound with existing technology; nor to perform this procedure transvaginally with the assistance of ultrasound.

详细描述

This is a feasibility study characterizing the ability of transvaginal ultrasonography to identify the pudendal nerve. The pudendal nerve is a sensory and motor nerve arising from the sacral plexus, innervating the perineum. Anesthesia of the pudendal nerve (pudendal nerve block) is used to assist during obstetrical procedures (forceps delivery, vaginal tear repair), to improve discomfort associated with vaginal delivery when time is not sufficient to place an epidural, and to reduce pain following certain urogynecological surgeries [1-4]. Pudendal nerve block is also used to manage chronic pain associated with pudendal neuralgia [5]. Today, the pudendal nerve block is typically accomplished through blind landmark techniques, thus limiting its success [6-7]. More recently, efforts have been made to attempt this procedure with ultrasound from a more external approach transglutially, however this method requires high level of technical skill and is associated with high failure rate when compared to a blind landmark technique [8-10]. Other methods of accomplishing pudendal nerve blocks include the use of fluoroscopy. However, these renders the procedure more costly and subjects the patient to the inherent risk of radiation [11]. To date, there has never been an attempt to determine if the visualization of the pudendal nerve would be possible using transvaginal ultrasound with existing technology; nor to perform this procedure transvaginally with the assistance of ultrasound.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Scheduled to undergo transvaginal ultrasound at the Fetal Care Center (FCC) or Gynecology clinic
  • Patients undergoing pelvic floor surgery at either the Main OR or outpatient surgery center at UVA will be included. This includes surgeries performed by surgeons in the Department of OBGYN, Division of Pelvic Medicine and Reconstructive Surgery, and includes surgeries for repair of prolapse, urinary incontinence, fistula, urethral diverticulum, or other pelvic floor issues.
  • >18 years age
  • English-speaking

排除标准

  • Refusal to participate

结局指标

主要结局

Observing the Pudendal Nerve

时间窗: day of study participate (1 day per participant)

We will use this study to determine if we can use transvaginal ultrasound to visualize the pudendal nerve through transvaginal ultrasound.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Monique Vaughan, MD

Assistant Professor

University of Virginia

研究点 (1)

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