Clinical trial NCT06021782: Characterization of the Pudendal Nerve with Transvaginal Ultrasonography
Official title: Characterization of the Pudendal Nerve with Transvaginal Ultrasonography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Keywords: pudendal nerve
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient scheduled to undergo transvaginal ultrasound at the Fetal Care Center (FCC) or Gynecology clinic. Or 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Observing the Pudendal Nerve
timeFrame: day of study participate (1 day per participant)
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
citation: KOBAK AJ, EVANS EF, JOHNSON GR. Transvaginal pudendal nerve block; a simple procedure for effective anesthesia in operative vaginal delivery. Am J Obstet Gynecol. 1956 May;71(5):981-9. No abstract available.
citation: Langhoff-Roos J, Lindmark G. Analgesia and maternal side effects of pudendal block at delivery. A comparison of three local anesthetics. Acta Obstet Gynecol Scand. 1985;64(3):269-72. doi: 10.3109/00016348509155127.
citation: Arslan M, Yazici G, Dilek U. Pudendal nerve block for pain relief in episiotomy repair. Int J Gynaecol Obstet. 2004 Nov;87(2):151-2. doi: 10.1016/j.ijgo.2004.06.020. No abstract available.
citation: Nikpoor P, Bain E. Analgesia for forceps delivery. Cochrane Database Syst Rev. 2013 Sep 30;9(9):CD008878. doi: 10.1002/14651858.CD008878.pub2.