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Completed

NCT Number: NCT07575204

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

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.

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Key information

Conditions

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

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bangladesh Medical University

Dhaka, 1000, Bangladesh

About this study

This randomized controlled trial aims to evaluate and compare the efficacy of ultrasound-guided pudendal nerve block (USG-PNB) and dorsal penile nerve block (DPNB) for postoperative analgesia in pediatric patients undergoing hypospadias repair surgery. Both techniques are regional anesthesia methods used to manage postoperative pain, but they differ in the sensory regions they target. The study seeks to determine which of these two techniques provides more effective pain relief and assess any associated complications.

A total of 60 pediatric patients, aged 1 to 6 years, undergoing hypospadias surgery under general anesthesia will be enrolled. Patients will be randomly assigned to receive either the USG-PNB or DPNB after induction of anesthesia. The primary outcome of the study is the first postoperative analgesic requirement, measured using the Face, Leg, Activity, Cry, Consolability (FLACC) pain scale. Secondary outcomes include time to first analgesic requirement, postoperative pain intensity at different time points, total analgesic consumption within the first 24 hours, and the monitoring of hemodynamic parameters, including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and complications related to either nerve block technique.

Patients will be monitored in the post-anesthetic care unit for 24 hours, during which pain levels and vital signs will be recorded.

By comparing the two regional anesthesia techniques, this study will contribute to improving postoperative pain management strategies, with a focus on minimizing side effects and improving recovery times in pediatric patients undergoing hypospadias surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 1 to 6 years.
  • Scheduled for hypospadias surgery under general anesthesia.
  • American Society of Anesthesiologists (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.

Exclusion criteria

  • 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.

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: 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

    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.

Secondary outcomes

  1. Time to First Postoperative Analgesic Requirement

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

    This outcome measures the time interval from the end of surgery to the first request for analgesic medication postoperatively. It is a key indicator of how long the nerve block techniques provide effective pain relief before additional pain medication is required.

  2. Total Postoperative Analgesic Consumption in the First 24 Hours

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

    This outcome measures the total amount of postoperative analgesic medication (including paracetamol, NSAIDs, and any rescue analgesics) consumed by patients during the first 24 hours after surgery. The purpose is to evaluate the effectiveness of the nerve block techniques in reducing the need for additional pain relief.

  3. Hear rate (HR)

    Time frame: 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.

    This outcome measures the heart rate of the patient postoperatively. Monitoring heart rate helps assess the cardiovascular stability of the patient after surgery and anesthesia.

  4. Systolic Blood Pressure (SBP)

    Time frame: 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.

    This outcome measures the systolic blood pressure of the patient postoperatively. It helps evaluate the impact of the nerve block techniques on the patient's blood pressure and circulatory status.

  5. Diastolic Blood Pressure (DBP)

    Time frame: 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.

    This outcome measures the diastolic blood pressure of the patient postoperatively. It provides additional insight into the patient's cardiovascular status and response to anesthesia and the nerve block techniques

  6. Mean Arterial Pressure (MAP)

    Time frame: From the end of surgery to 24 hours post-surgery, with mean arterial pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.

    This outcome measures the mean arterial pressure, which is an important indicator of the perfusion pressure and the overall stability of the patient's cardiovascular system after surgery. It reflects the pressure necessary to ensure adequate blood flow to organs and tissues.

  7. Complications related to nerve block

    Time frame: From the end of surgery to 24 hours post-surgery, with any complications or adverse events documented during the recovery period.

    This outcome involves the monitoring and recording of any complications or adverse effects associated with either the ultrasound-guided pudendal nerve block or dorsal penile nerve block. This includes, but is not limited to, issues such as infection, hematoma formation, nerve injury, or systemic reactions to the anesthetics.

Sponsors and collaborators

Lead sponsor

Bangladesh Medical University

Other

Registry information

Official study title

Effectiveness of Ultrasound-Guided Pudendal Versus Dorsal Penile Nerve Block for Postoperative Analgesia in Paediatric Hypospadias Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 12, 2026

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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