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Characterization of the Pudendal Nerve with Transvaginal Ultrasonography

Characterization of the Pudendal Nerve with Transvaginal Ultrasonography

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06021782
Enrollment
24
Registered
2023-09-01
Start date
2021-05-13
Completion date
2026-12-31
Last updated
2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

pudendal nerve

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.

Interventions

OTHERAll subjects-Observation

The sonographer or study team member will scan the lateral vaginal walls (Left and right) directing the probe slightly caudad in direction of the ischial spine (IS). The IS is very echogenic and easily identifiable (bony landmark). Anatomically, the pudendal nerve courses underneath the IS and travels with the vascular bundle of the pudendal artery and pudendal vein. The artery and the vein will be identified using color flow Doppler at the time of the scan. These landmarks, IS, pudendal artery and vein will serve as the basis for the identification of the pudendal nerve.

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026