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

NCT ID: NCT06895382

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-12-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Caudal Epidural Block

Intervention Type: 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.

Bupivacaine 0.25%

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Transversus Abdominis Plane (TAP) Block

Intervention Type: 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.

Bupivacaine 0.25%

Intervention Type: 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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Other Intervention Names

Caudal Block; Caudal Anesthesia; TAP Block; Ultrasound-Guided TAP Block

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Namik Kemal University

OTHER

Sponsor Role: lead

Responsible Party

Onur Baran

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Onur Baran

Role: STUDY_CHAIR

Namik Kemal University

Locations

Tekirdag Namik Kemal University

Tekirdağ, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TNKU-PED-ANES-2022-001

Identifier Type: -

Identifier Source: org_study_id