Ultrasound-Guided Pudendal vs Dorsal Penile Nerve Block for Pediatric Hypospadias Surgery

NCT07575204 | Completed

• 1 other identifier: #5734
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effectiveness and safety of two regional anesthesia techniques, ultrasound-guided pudendal nerve block and dorsal penile nerve block, for postoperative pain management in children undergoing hypospadias surgery. The main questions we aim to answer are: Which technique provides more effective pain relief after surgery? What are the potential side effects or complications associated with each technique? Participants will: Receive either an Ultrasound-guided pudendal nerve block or a dorsal penile nerve block in combination with general anesthesia after surgery. Participants will be monitored for pain levels using a pediatric pain scale Face, Leg, Activity, Cry, Consolability (FLACC) and their overall recovery for the first 24 hours post-surgery. Have their total analgesic consumption and vital signs recorded during the recovery period. This study will help improve postoperative pain management strategies for pediatric hypospadias surgery by evaluating these two anesthesia techniques.

Conditions

Hypospadias; Pudendal Nerve Block; Penile Nerve Block; Postoperative Pain

Keywords

Hypospadias; Dorsal penile nerve block; Postoperative analgesia; Pudendal nerve block

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity by using Face, Leg, Activity, Cry, Consolability (FLACC) scale

  The primary outcome measure of this study is the postoperative pain intensity, which will be assessed using the Face, Leg, Activity, Cry, Consolability (FLACC) scale. This scale is designed to evaluate pain in young children who cannot verbally communicate their discomfort. It consists of five categories: Face: The facial expression of the child (e.g., no expression, occasional grimace, or frequent grimace). Legs: The position of the child's legs (e.g., relaxed, tense, or kicking). Activity: The child's level of activity (e.g., lying quietly, squirming, or arching). Cry: The type and frequency of crying (e.g., no cry, occasional complaints, or crying steadily). Consolability: How easily the child can be comforted (e.g., content, reassured by touch, or difficult to console). Each category is scored from 0 to 2, with a total score ranging from 0 to 10. A higher score indicates higher pain intensity.

  From the end of surgery to 24 hours post-surgery This includes assessments of postoperative pain intensity using the FLACC scale at various time points, starting immediately after surgery and continuing at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery

Secondary Outcomes (7)

• Time to First Postoperative Analgesic Requirement

  From the end of surgery to the first analgesic requirement, within the first 24 hours post-surgery.

• Total Postoperative Analgesic Consumption in the First 24 Hours

  From the end of surgery to 24 hours post-surgery, with total analgesic consumption recorded at regular intervals.

• Hear rate (HR)

  From the end of surgery to 24 hours post-surgery, with heart rate recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.

• Systolic Blood Pressure (SBP)

  From the end of surgery to 24 hours post-surgery, with systolic blood pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.

• Diastolic Blood Pressure (DBP)

  From the end of surgery to 24 hours post-surgery, with diastolic blood pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.

Study Arms (2)

Ultrasound-Guided Pudendal Nerve Block Group

EXPERIMENTAL

In this arm, participants will receive ultrasound-guided pudendal nerve block (PNB) for postoperative pain management following hypospadias surgery. The procedure involves the administration of 0.25% bupivacaine (0.2-0.5 mL/kg) mixed with 0.05 mg/kg dexamethasone to block the pudendal nerve. The block will be performed under direct ultrasound visualization after induction of general anesthesia, targeting the perineal area, including both superficial and deeper penile tissues. The effects of this intervention will be compared to the dorsal penile nerve block group in terms of postoperative pain relief and analgesic consumption.

Procedure: Ultrasound-Guided Pudendal Nerve Block

Ultrasound-Guided Dorsal Penile Nerve Block Group

ACTIVE COMPARATOR

Ultrasound-Guided Dorsal Penile Nerve Block Group: In this arm, participants will receive ultrasound-guided dorsal penile nerve block (DPNB) for postoperative pain management following hypospadias surgery. The procedure involves the administration of 0.25% bupivacaine (0.5 mL/kg) mixed with 0.05 mg/kg dexamethasone, targeting the dorsal penile nerve. The block will be performed under direct ultrasound visualization at the penoscrotal junction, focusing on the distal penile region. The effects of this intervention will be compared to the pudendal nerve block group in terms of postoperative pain relief and analgesic consumption

Procedure: Ultrasound-Guided Dorsal Penile Nerve Block

Interventions

Ultrasound-Guided Pudendal Nerve Block PROCEDURE

This intervention involves the use of ultrasound guidance to perform a pudendal nerve block for postoperative pain relief in pediatric patients undergoing hypospadias surgery. The procedure targets the pudendal nerve, which provides sensory innervation to the perineal area, including the genitalia. The block is performed by injecting a mixture of 0.25% bupivacaine and dexamethasone under ultrasound visualization, ensuring precise placement of the needle. This method aims to provide comprehensive analgesia for both superficial and deeper tissues, reducing the need for additional systemic analgesics and improving postoperative recovery.

Ultrasound-Guided Pudendal Nerve Block Group

Ultrasound-Guided Dorsal Penile Nerve Block PROCEDURE

This intervention involves the use of ultrasound guidance to perform a dorsal penile nerve block for postoperative pain management in pediatric patients undergoing hypospadias surgery. The procedure targets the dorsal penile nerve, which innervates the distal part of the penis. Under ultrasound visualization, a mixture of 0.25% bupivacaine and dexamethasone is injected near the nerve to provide localized analgesia. This block is designed to alleviate pain in the distal penile area but may not offer as broad a sensory coverage as the pudendal nerve block, particularly for deeper tissues.

Ultrasound-Guided Dorsal Penile Nerve Block Group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 1 to 6 years.
• Scheduled for hypospadias surgery under general anesthesia.
• ASA physical status I or II (healthy children or those with mild systemic disease).
• Parents or legal guardians willing to provide written informed consent.
• Patients who meet the study's medical and surgical eligibility after pre-anesthetic evaluation.

You may not qualify if:

• Allergy to local anesthetics (e.g., bupivacaine).
• Patient or parent refusal to participate.
• Local infection or inflammation at the site of Block placement.
• Anatomical deformities that may interfere with the Block administration.
• Coagulopathy or bleeding disorders.
• Severe systemic conditions (e.g., ASA physical status III or IV).
• History of adverse reactions to nerve blocks or regional anesthesia.

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (27)

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MeSH Terms

Conditions

Hypospadias; Pain, Postoperative

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• AKM Akhtaruzzaman, MD

  Bangladesh Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

BA (1)