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

NCT06895382 | Completed

• 1 other identifier: TNKU-PED-ANES-2022-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Caudal Epidural Block; Transversus Abdominis Plane Block; Pediatric Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total Postoperative Analgesic Consumption

  0-24 hours postoperatively

• Intraoperative Hemodynamic Stability

  Baseline, after induction, after surgical incision, and at 15, 30, 45, and 60 minutes intraoperatively.

• Incidence of Postoperative Nausea and Vomiting (PONV)

  0-24 hours postoperatively

• Parental Satisfaction Scores

  Recorded at 24 hours postoperatively and at a follow-up phone call after discharge.

Study Arms (2)

Group C - Caudal Epidural Block

EXPERIMENTAL

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; Drug: Bupivacaine 0.25%

Group T - Transversus Abdominis Plane (TAP) Block

EXPERIMENTAL

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; Drug: Bupivacaine 0.25%

Interventions

Caudal Epidural Block PROCEDURE

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.

Also known as: Caudal Block, Caudal Anesthesia

Group C - Caudal Epidural Block

Transversus Abdominis Plane (TAP) Block PROCEDURE

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.

Also known as: TAP Block, Ultrasound-Guided TAP Block

Group T - Transversus Abdominis Plane (TAP) Block

Bupivacaine 0.25% DRUG

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

Group C - Caudal Epidural Block; Group T - Transversus Abdominis Plane (TAP) Block

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Tekirdag Namik Kemal University

Tekirdağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Caudal; Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Epidural; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Onur Baran

  Namik Kemal University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study was single-blinded, with postoperative pain assessors blinded to the group allocation. The anesthesiologist administering the block was aware of the group assignment, but postoperative evaluators were not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study compares two regional anesthesia techniques for postoperative analgesia in pediatric patients undergoing infraumbilical surgery. Participants were randomized into two groups: Group C (Caudal Block) and Group T (TAP Block). Pain scores, analgesic consumption, and adverse effects were compared.

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: December 15, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)