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

G

Giresun University

Status

Completed

Conditions

Urinary Incontinence

Treatments

Procedure: Pudendal Nerve Block

Study type

Interventional

Funder types

Other

Identifiers

NCT07029087
Azime Bulut

Details and patient eligibility

About

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.

Full description

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.

Enrollment

58 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

58 participants in 2 patient groups

Pudendal
Experimental group
Description:
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.
Treatment:
Procedure: Pudendal Nerve Block
Control
No Intervention group
Description:
All patients were operated under spinal anesthesia. After surgery we followed up the hemodynamic values and VAS scores at different time points.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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