The Effect of Ultrasound Guided Pudendal Block on Postoperative Analgesia in Urogynecological Surgeries

NCT07029087 | Completed

• 1 other identifier: Azime Bulut
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Stress urinary incontinence (SUI) is one of the most common problems encountered in gynecology outpatient clinics and affects approximately 4% to 35% of women. Although it is a medical condition, it also negatively impacts women's quality of life, making successful treatment of this condition particularly important from the patient's perspective. Additionally, overactive bladder and pelvic organ prolapse are frequently seen, especially in older women, and surgical procedures such as transobturator tape (TOT), cystocele repair, and rectocele repair are commonly performed to address these issues. In general, any type of surgical procedure in elderly patients is considered to carry higher risks compared to the younger population. Specifically, in prolapse surgeries, longer hospital stays and higher rates of perioperative complications have been reported compared to younger patients . Moreover, postoperative pain is a significant barrier to the resumption of daily activities. The innervation of the perineal portion of the pelvic floor muscles is provided by the pudendal nerve, which originates from the ventral roots of sacral segments S2 to S4. Pudendal nerve blocks are often preferred as an initial diagnostic and therapeutic method for chronic pelvic pain caused by pudendal neuralgia due to nerve entrapment. Additionally, the pudendal nerve block is a widely used regional anesthesia technique in gynecologic, obstetric, and anorectal procedures . It is particularly applied to provide perineal anesthesia during the second stage of vaginal delivery, vaginal repairs, and obstetric procedures including anorectal surgeries such as hemorrhoidectomy . Pudendal nerve blocks can effectively anesthetize the posterior perineum, anus, lower vagina, vulva/scrotum, and penis. In this study, the investigators aimed to demonstrate the effectiveness of the pudendal nerve block in achieving postoperative analgesic control during urogynecological surgeries such as TOT, cystocele, and rectocele repairs, and thereby facilitating an earlier return to daily activities.

Conditions

Urinary Incontinence

Keywords

postoperative analgesia; pudendal block; urogynecological surgery

Outcome Measures

Primary Outcomes (1)

• Visual analog scale

  The primary endpoint was the postoperative pain on the visual analogue scale (VAS) at 24 h. The investigators evaluated the pain intensity by using the VAS, where 0 indicated no pain and 10 represented the worst imaginable pain.

  24 hours after surgery

Secondary Outcomes (3)

• Length of hospital stay

  14 days after surgery

• The time of sitting without pain

  24 hours after surgery

• Analgesic need

  24 hours after surgery

Study Arms (2)

Pudendal

EXPERIMENTAL

We performed pudendal nerve block by using ultrasound at the end of the surgery. All patients were operated under spinal anesthesia. After surgery we followed up the hemodynamic changes and VAS values at different time points.

Procedure: Pudendal Nerve Block

Control

NO INTERVENTION

All patients were operated under spinal anesthesia. After surgery we followed up the hemodynamic values and VAS scores at different time points.

Interventions

Pudendal Nerve Block PROCEDURE

Pudendal nerve blocks are often preferred as an initial diagnostic and therapeutic method for chronic pelvic pain caused by pudendal neuralgia due to nerve entrapment. Additionally, the pudendal nerve block is a widely used regional anesthesia technique in gynecologic, obstetric, and anorectal procedures . It is particularly applied to provide perineal anesthesia during the second stage of vaginal delivery, vaginal repairs, and obstetric procedures including anorectal surgeries such as hemorrhoidectomy . Pudendal nerve blocks can effectively anesthetize the posterior perineum, anus, lower vagina, vulva/scrotum, and penis.

Pudendal

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The investigators performed the pudendal nerve block to the patients who operated for urinary incontinence.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun Training and Research Hospital

Giresun, Turkey (Türkiye)

Location

Related Publications (3)

• Naja Z, El-Rajab M, Al-Tannir M, Ziade F, Zbibo R, Oweidat M, Lonnqvist PA. Nerve stimulator guided pudendal nerve block versus general anesthesia for hemorrhoidectomy. Can J Anaesth. 2006 Jun;53(6):579-85. doi: 10.1007/BF03021848.

  PMID: 16738292 BACKGROUND

• He J, Zhang L, Li DL, He WY, Xiong QM, Zheng XQ, Liao MJ, Wang HB. Ultrasound-Guided Pudendal Nerve Block Combined with Propofol Deep Sedation versus Spinal Anesthesia for Hemorrhoidectomy: A Prospective Randomized Study. Pain Res Manag. 2021 Feb 26;2021:6644262. doi: 10.1155/2021/6644262. eCollection 2021.

  PMID: 33727997 BACKGROUND

• Di Giuseppe M, Saporito A, La Regina D, Tasciotti E, Ghielmini E, Vannelli A, Pini R, Mongelli F. Ultrasound-guided pudendal nerve block in patients undergoing open hemorrhoidectomy: a double-blind randomized controlled trial. Int J Colorectal Dis. 2020 Sep;35(9):1741-1747. doi: 10.1007/s00384-020-03630-x. Epub 2020 May 30.

  PMID: 32474710 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Azime Bulut, Assoc.Prof.

  Giresun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomized-controlled, double-blind study

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 19, 2025
• Study Start: May 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)