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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Anesthesia, Local; Abdominal Surgery; Regional Anesthesia; Pediatric Surgery
• Intervention / Treatment: Procedure: Caudal Epidural Block; Procedure: Transversus Abdominis Plane (TAP) Block; Drug: Bupivacaine 0.25%

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tekirdağ, Turkey
    • Tekirdag Namik Kemal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group C - Caudal Epidural Block; 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.	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.; Other Names: Caudal Block; Caudal Anesthesia; 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
Experimental: Group T - Transversus Abdominis Plane (TAP) Block; 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.	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.; Other Names: TAP Block; Ultrasound-Guided TAP Block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative FLACC Pain Scores	Postoperative pain intensity was measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at predefined time points after surgery. The FLACC scale is a validated tool for assessing postoperative pain in pediatric patients based on behavioral observations.	FLACC pain scores were recorded at 2, 6, 12, and 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Postoperative Analgesic Consumption	The total amount of rescue analgesia (paracetamol, NSAIDs, opioids) administered in the first 24 hours postoperatively was recorded. This includes any additional medication given based on the patient's pain score.	0-24 hours postoperatively
Incidence of Postoperative Nausea and Vomiting (PONV)	The number of patients experiencing postoperative nausea and vomiting (PONV) within the first 24 hours was recorded.	0-24 hours postoperatively
Parental Satisfaction Scores	Parental satisfaction with their child's postoperative pain management was assessed using a 5-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied).	Recorded at 24 hours postoperatively and at a follow-up phone call after discharge.
Intraoperative Hemodynamic Stability	Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and arterial oxygen saturation (SpO₂) were recorded at predefined intraoperative time points to assess the hemodynamic effects of the regional anesthesia techniques.	Baseline, after induction, after surgical incision, and at 15, 30, 45, and 60 minutes intraoperatively.

Collaborators and Investigators

• Sponsor: Namik Kemal University
• Investigators: Study Chair: Onur Baran, Namik Kemal University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Transversus Abdominis Plane Block; Caudal Epidural Block; Pediatric Pain Management
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: TNKU-PED-ANES-2022-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No