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Characterization of the Pudendal Nerve with Transvaginal Ultrasonography

Recruiting
Conditions
Anesthesia
Interventions
Other: All subjects-Observation
Registration Number
NCT06021782
Lead Sponsor
University of Virginia
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
24
Inclusion Criteria
  • 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
Exclusion Criteria

• Refusal to participate

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
All subjectsAll subjects-ObservationPatients scheduled to have their transvaginal ultrasound for medical reasons at the fetal care center and gynecology clinic will be asked to participate in this study. Also, patients undergoing pelvic floor surgery at either the Main OR or outpatient surgery center at UVA will be asked to participate.
Primary Outcome Measures
NameTimeMethod
Observing the Pudendal Nerveday 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Virginia

🇺🇸

Charlottesville, Virginia, United States

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