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NCT Number: NCT07619651

Comparison of Sacral ESP Block and Caudal Block in Pediatric Hypospadias Surgery

Hypospadias surgery in pediatric patients requires effective postoperative analgesia to ensure patient comfort and reduce perioperative stress. Caudal epidural block is widely used for analgesia in pediatric urological procedures; however, alternative regional techniques such as the sacral erector spinae plane (ESP) block have recently gained attention.

This prospective comparative study aims to compare the analgesic efficacy of sacral ESP block and caudal epidural block in pediatric patients undergoing hypospadias surgery. Participants will be allocated to receive either sacral ESP block or caudal epidural block according to the study protocol.

The primary outcome will be postoperative pain scores within the first 24 hours after surgery. Secondary outcomes will include total analgesic consumption, time to first rescue analgesia, and block-related complications.

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Key information

Age range

6 month–7 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Hypospadias is one of the most common congenital urogenital anomalies in pediatric patients and typically requires surgical correction in early childhood. Effective postoperative pain management is essential to improve patient comfort, reduce perioperative stress, and prevent complications. Inadequate pain control in pediatric surgical patients has been associated with increased morbidity, prolonged hospital stay, and delayed recovery.

Caudal epidural block is widely used for postoperative analgesia in pediatric urological surgery due to its ease of application and high success rate. However, it has limitations such as relatively short duration of analgesia and potential side effects including motor block, urinary retention, and lower extremity weakness. Therefore, alternative regional anesthesia techniques that may provide longer-lasting analgesia with fewer side effects are of increasing interest.

The erector spinae plane (ESP) block is a relatively novel regional anesthesia technique that provides both somatic and visceral analgesia and can be applied at different spinal levels. The sacral approach to ESP block has recently been described as a potential alternative for lower abdominal and urogenital surgeries. However, evidence regarding its effectiveness in pediatric hypospadias surgery remains limited.

This prospective comparative study aims to compare the analgesic efficacy, postoperative analgesic requirements, and block-related complications of sacral erector spinae plane block and caudal epidural block in pediatric patients undergoing hypospadias repair surgery.

Patients aged between 6 months and 7 years with ASA physical status I-II scheduled for hypospadias repair will be included. Participants will be allocated into either the sacral ESP block group or the caudal epidural block group according to the study protocol.

All patients will receive standardized general anesthesia and monitoring. Regional blocks will be performed under general anesthesia prior to surgery. In the sacral ESP block group, the block will be performed under ultrasound guidance using an in-plane technique, and 0.25% bupivacaine at a dose of 0.5 mL/kg will be administered. In the caudal epidural block group, the block will be performed using a standard technique with 0.25% bupivacaine at a dose of 0.5 mL/kg.

Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 30 minutes, and at 1, 4, 12, and 24 hours after surgery. Total postoperative analgesic consumption, time to first rescue analgesia, and block-related complications (including motor weakness, nausea and vomiting, hypotension, bradycardia, pruritus, intravascular injection, and bleeding) will be recorded.

Statistical analysis will be performed using appropriate tests according to data distribution, with a significance level set at p < 0.05.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male patients aged between 6 months to 7 years
  • Scheduled for hypospadias repair surgery
  • ASA physical status I-II
  • No known allergy to local anesthetic agents
  • No contraindications to peripheral nerve blocks
  • Written informed consent obtained from parents or legal guardians

Exclusion criteria

  • Known congenital coagulopathy
  • Known allergy to local anesthetic agents
  • Severe systemic disease (ASA III-IV)
  • Severe organ failure
  • Neurological disorders

Treatment and study plan

Sacral ESP Block

Procedure

Sacral erector spinae plane block will be performed under ultrasound guidance in pediatric patients under general anesthesia. A linear ultrasound probe will be placed in the longitudinally over the sacral region to identify the sacral median crest and erector spinae muscle. Using an in-plane technique, a block needle will be advanced in a cranial-to-caudal direction, and after negative aspiration, 0.25% bupivacaine at a dose of 0.5 mL/kg will be injected beneath the erector spinae muscle at the level of the sacral vertebra. The injection will be performed incrementally with intermittent aspiration to avoid intravascular injection.

Caudal Epidural Block

Procedure

Caudal epidural block will be performed in pediatric patients under general anesthesia in the lateral decubitus position. The sacrococcygeal membrane will be identified using anatomical landmarks, and a needle will be inserted into the caudal epidural space. After negative aspiration, 0.25% bupivacaine at a dose of 0.5 mL/kg will be administered slowly. Intermittent aspiration will be performed during injection to minimize the risk of intravascular or intrathecal injection.

Primary outcomes

  1. Postoperative Pain Score Assessed by FLACC Scale

    Time frame: Within the first 24 hours after surgery

    Postoperative pain intensity will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale in pediatric patients undergoing hypospadias repair surgery. The FLACC scale consists of five behavioral categories (Face, Legs, Activity, Cry, Consolability), each scored from 0 to 2 points, resulting in a total score ranging from 0 to 10. Higher scores indicate greater pain intensity. FLACC scores will be recorded at 30 minutes, and at 1, 4, 12, and 24 hours after surgery. Rescue analgesia will be administered when the FLACC score is 4 or greater.

Secondary outcomes

  1. Time to First Rescue Analgesia

    Time frame: Within the first 24 hours after surgery

    Time from the end of surgery to the first administration of rescue analgesic medication will be recorded.

  2. Total Postoperative Analgesic Consumption

    Time frame: Within the first 24 hours after surgery

    Total amount of analgesic medications required within the first 24 hours after surgery will be recorded.

  3. Block-Related Complications

    Time frame: Within the first 24 hours after surgery

    Block-related complications including motor weakness, nausea and vomiting, hypotension, bradycardia, pruritus, intravascular injection, and bleeding will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

RABİA BÜŞRA SATICI, MD

CONTACT

[email protected]

0905548846343

ÖZLEM ÖZ GERGİN, MD

CONTACT

[email protected]

0905332466396

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Prospective Comparison of Sacral Erector Spinae Plane Block and Caudal Epidural Block for Postoperative Analgesia in Pediatric Hypospadias Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2026
Registry last updated
Jun 25, 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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