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NCT Number: NCT07029087

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Giresun Training and Research Hospital

Giresun, Turkey (Türkiye)

About this study

The study was planned to be conducted prospectively, in a randomized and controlled manner on female patients who were scheduled for elective urogynecological surgery in the obstetrics operating room of Giresun Women's and Children's Hospital. Written and verbal informed consent will be obtained from all patients who agree to participate in the study. Group allocation will be determined using a randomization method via sealed opaque envelopes. The patients' age, height, weight, and American Society of Anesthesiologists (ASA) physical status classification will be recorded.

All patients will receive spinal anesthesia before surgery in the obstetrics operating room. At the end of the surgery, patients in the block group will undergo pudendal nerve block under ultrasound guidance. For the block procedure, aseptic preparation will be performed on the perineal area of the patient in the lithotomy position. A 21-gauge, 100 mm Stimuplex peripheral nerve block needle will be used. A linear ultrasound probe will be placed on the perineum at the 3 and 9 o'clock positions relative to the anus to visualize the ischial tuberosity. The needle will be inserted in an out-of-plane approach, medially to the ischial tuberosity, to reach the area between the sacrotuberous and sacrospinous ligaments. A total of 10 ml of 0.25% plain bupivacaine, diluted with isotonic solution, will be administered bilaterally.

Postoperative pain assessments using the Visual Analog Scale (VAS) will be performed at 2, 4, 6, 12, 24, and 48 hours in both the block and control groups. If a patient reports a VAS score greater than 4, intramuscular diclofenac sodium will be administered and recorded. Additionally, the time at which patients can sit without pain, the time to return to daily activity, and length of hospital stay will also be documented.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

>18 years ASA I-II scores Clinical diagnosis of urinary incontinence The patients with consent to be included in the study - Exclusion Criteria: Patients who suffer from chronic pain Patients using regular analgesic drugs Pregnant patients Allergic reactions to local anesthetics ASA III and over patients Need for general anesthesia

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Treatment and study plan

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.

Primary outcomes

  1. Visual analog scale

    Time frame: 24 hours after surgery

    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.

Secondary outcomes

  1. Length of hospital stay

    Time frame: 14 days after surgery

    Length of hospital stay: The number of days that stayed in hospital

  2. The time of sitting without pain

    Time frame: 24 hours after surgery

    The investigators recorded how many hours after the surgery the patients were able to sit without pain.

  3. Analgesic need

    Time frame: 24 hours after surgery

    Analgesic consumption: Total amount of analgesic need during first 24 hours on postoperative period.

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

The Effect of Pudendal Block on Postoperative Analgesia in Urogynecological Surgeries

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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