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

Namik Kemal University

Status: Completed

Conditions: Postoperative Pain; Anesthesia, Local; Pediatric Surgery; Abdominal Surgery; Regional Anesthesia

Treatments: Drug: Bupivacaine 0.25%; Procedure: Caudal Epidural Block; Procedure: Transversus Abdominis Plane (TAP) Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06895382

TNKU-PED-ANES-2022-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients aged 1 to 7 years.
• ASA Physical Status I-II.
• Undergoing infraumbilical abdominal surgery (e.g., hernia repair, orchiopexy, circumcision).
• Parental written informed consent obtained.

Exclusion criteria

• Contraindications to regional anesthesia, such as:
• Coagulopathy or bleeding disorders.
• Local infection at the injection site.
• Known allergy to local anesthetics.
• Neurological conditions (e.g., degenerative neuropathy, brain tumors, increased intracranial pressure).
• Intellectual disabilities affecting pain assessment.
• Chronic pain conditions or opioid use before surgery.
• Parental refusal to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group C - Caudal Epidural Block

Experimental group

Description:

Participants in this group received a caudal epidural block after the induction of general anesthesia. A 35-mm 22G or 30-mm 25G block 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.

Treatment:

Procedure: Caudal Epidural Block

Drug: Bupivacaine 0.25%

Group T - Transversus Abdominis Plane (TAP) Block

Experimental group

Description:

Participants in this group received an ultrasound-guided transversus abdominis plane (TAP) block after the induction of general anesthesia. A 22G, 50-mm insulated block needle was inserted using an in-plane technique under ultrasound guidance with a linear probe. 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.

Treatment:

Procedure: Transversus Abdominis Plane (TAP) Block

Drug: Bupivacaine 0.25%