NCT06895382

Caudal Epidural Vs. TAP Block for Postoperative Analgesia in Pediatric Infraumbilical Surgery: a RCT

Comparison of Caudal Epidural Block and Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia in Pediatric Infraumbilical Surgery: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Namik Kemal University · Academic / Other
• Sex: All
• Age: 1 Year – 7 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial investigates the postoperative analgesic efficacy of caudal epidural block versus ultrasound-guided transversus abdominis plane (TAP) block in pediatric patients undergoing infraumbilical surgery. A total of 60 pediatric patients (aged 1 to 7 years, ASA I-II) were randomly assigned to one of two groups: * Group C (Caudal Block): Received 1 mL/kg of 0.25% bupivacaine in the caudal epidural space. * Group T (TAP Block): Received 0.3 mL/kg of 0.25% bupivacaine injected into the transversus abdominis plane under ultrasound guidance. Primary Outcome: * Postoperative FLACC pain scores at 2, 6, 12, and 24 hours. Secondary Outcomes: * Total analgesic consumption (including rescue analgesia). * Intraoperative hemodynamic parameters (heart rate, blood pressure, SpO₂). * Incidence of nausea and vomiting (PONV). * Parental satisfaction scores. The study aims to determine which regional anesthesia technique provides superior pain relief and reduces systemic analgesic requirements in pediatric patients.

Detailed description

Postoperative pain management in pediatric patients is a challenge due to difficulties in pain assessment and concerns about opioid-related adverse effects. While caudal epidural block has traditionally been the standard of care for infraumbilical pediatric surgeries, ultrasound-guided transversus abdominis plane (TAP) block has emerged as a promising alternative with the potential for longer-lasting analgesia and fewer motor block complications. This randomized controlled trial was conducted at Tekirdağ Namık Kemal University Hospital between December 2022 and December 2023. A total of 60 pediatric patients (aged 1-7 years, ASA I-II) undergoing infraumbilical surgery were enrolled and randomly assigned to receive either: * Caudal epidural block (1 mL/kg of 0.25% bupivacaine via the sacral hiatus). * TAP block (0.3 mL/kg of 0.25% bupivacaine in the fascial plane between the internal oblique and transversus abdominis muscles under ultrasound guidance). General anesthesia was induced using sevoflurane inhalation, followed by propofol (2-3 mg/kg) and fentanyl (1 µg/kg) for IV induction. A laryngeal mask airway (LMA) was used, and anesthesia was maintained with sevoflurane at a MAC of 1.0%. Outcome Measures: * Primary Outcome: * FLACC pain scores at 2, 6, 12, and 24 hours postoperatively. * Secondary Outcomes: * Total postoperative analgesic consumption (including rescue analgesia). * Hemodynamic parameters (HR, SBP, DBP, SpO₂) recorded at predefined intraoperative time points. * Incidence of postoperative nausea and vomiting (PONV). * Parental satisfaction scores collected post-discharge. Statistical Analysis: Data were analyzed using SPSS 25.0. Sample size was determined using G\*Power 3.1.9.2, with an effect size (d) of 0.75, power of 0.80, and Type I error of 0.05. The study followed randomized allocation with blinding of pain assessors. This study aims to determine whether TAP block provides equivalent or superior analgesia compared to caudal epidural block in pediatric patients undergoing infraumbilical surgeries. Findings will help guide future pediatric regional anesthesia protocols.

Conditions

• Postoperative Pain
• Pediatric Surgery
• Anesthesia, Local
• Regional Anesthesia
• Abdominal Surgery

Interventions

Type	Name	Description
PROCEDURE	Caudal Epidural Block	A caudal epidural block was performed after the induction of general anesthesia. Using a 35-mm 22G or 30-mm 25G block needle, the sacral hiatus was identified, and the needle was inserted through the sacrococcygeal ligament into the epidural space under aseptic conditions. After confirming negative aspiration for cerebrospinal fluid or blood, 1 mL/kg of 0.25% bupivacaine was administered.
PROCEDURE	Transversus Abdominis Plane (TAP) Block	A transversus abdominis plane (TAP) block was performed after the induction of general anesthesia. Using a 22G, 50-mm insulated block needle, the injection was administered under ultrasound guidance using a linear probe and in-plane technique. The needle was advanced into the fascial plane between the internal oblique and transversus abdominis muscles. After confirming placement with a 0.5-1 mL test dose of 0.9% NaCl and negative aspiration for blood, 0.3 mL/kg of 0.25% bupivacaine was administered.
DRUG	Bupivacaine 0.25%	0.25% bupivacaine was administered in both intervention arms as part of the regional anesthesia procedure In the Caudal Block group, 1 mL/kg of 0.25% bupivacaine was administered into the caudal epidural space. In the TAP Block group, 0.3 mL/kg of 0.25% bupivacaine was administered into the transversus abdominis plane under ultrasound guidance

Timeline

• Start date: 2022-12-15
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2025-03-26
• Last updated: 2025-04-01

Locations

1 site across 1 country: Turkey (Türkiye)