Comparison of Sacral ESP Block and Dorsal Penile Nerve Block in Pediatric Hypospadias Surgery

Official title

Comparison of the Effects of Sacral Erector Spinae Plane Block and Dorsal Penile Nerve Block on Postoperative Pain Management in Pediatric Patients Undergoing Hypospadias Surgery

Overview

This randomized controlled trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block versus Dorsal Penile Nerve Block (DPNB) in pediatric patients aged 1-7 years undergoing hypospadias surgery. The primary outcome is the pain score assessed by the FLACC scale at the 12th postoperative hour

Detailed description

Hypospadias surgery in pediatric patients can cause significant postoperative pain. While Dorsal Penile Nerve Block (DPNB) is a standard regional technique, the Sacral Erector Spinae Plane (ESP) block has emerged as a potential alternative for trunk and pelvic analgesia.

In this prospective, randomized, double-blind study, 70 pediatric patients (ASA I-II, aged 1-7 years) will be randomly assigned to receive either a Sacral ESP block or a DPNB under general anesthesia. Both blocks will be performed under ultrasound guidance using 0.25% bupivacaine, administered at a volume of 0.4 mL/kg for the Sacral ESP block and 0.4 mL/kg for the DPNB.

Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 30 minutes, 1, 2, 6, 12, and 24 hours. The study aims to determine if Sacral ESP provides superior or non-inferior analgesia compared to DPNB, specifically focusing on the 12th-hour pain scores, total analgesic consumption, and time to first rescue analgesic

Interventions

• Procedure Sacral ESP Block Group
  Patients will be placed in the lateral decubitus position. Under ultrasound guidance, the plane between the multifidus muscle and the sacral lamina (erector spinae plane) will be identified at the sacral level. A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally
• Procedure Dorsal Penile Nerve Block Group
  Patients will be in the supine position. Under ultrasound guidance, the needle will be advanced under Buck's fascia at the penile base (pubic symphysis level). A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally

Primary outcome measures

• Postoperative Pain Score (FLACC) at 12 Hours [Time frame: 30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery]

Secondary outcome measures (3)

• Total Postoperative Analgesic Consumption [Time frame: 24 hours post-surgery]
• Incidence of Postoperative Complications. [Time frame: Up to 24 hours]
• Postoperative Pain Scores (FLACC) at Other Time Points [Time frame: 30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery]

Eligibility criteria

Inclusion criteria

• Pediatric male patients aged 1-7 years.
• ASA (American Society of Anesthesiologists) physical status I or II.
• Scheduled for elective hypospadias surgery.
• Written informed consent obtained from parents/guardians

Exclusion criteria

• History of neurological deficit or developmental delay.
• Bleeding diathesis or known coagulopathy.
• History of allergy to local anesthetics.
• Infection or skin lesion at the block injection site.
• Congenital spinal anomaly.
• Mental retardation or history of psychiatric disease.
• Liver or kidney dysfunction

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Istanbul Medipol University — Istanbul

Identifiers

NCT: NCT07426731 · 149

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗