Clinical trial NCT06895382: Caudal Epidural Vs. TAP Block for Postoperative Analgesia in Pediatric Infraumbilical Surgery: a RCT
Official title: Comparison of Caudal Epidural Block and Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia in Pediatric Infraumbilical Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Pediatric Surgery
Anesthesia, Local
Regional Anesthesia
Abdominal Surgery
Keywords: Caudal Epidural Block
Transversus Abdominis Plane Block
Pediatric Pain Management
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative FLACC Pain Scores
timeFrame: FLACC pain scores were recorded at 2, 6, 12, and 24 hours postoperatively
Secondary outcomes:
measure: Total Postoperative Analgesic Consumption
timeFrame: 0-24 hours postoperatively
measure: Intraoperative Hemodynamic Stability
timeFrame: Baseline, after induction, after surgical incision, and at 15, 30, 45, and 60 minutes intraoperatively.
measure: Incidence of Postoperative Nausea and Vomiting (PONV)
timeFrame: 0-24 hours postoperatively
measure: Parental Satisfaction Scores
timeFrame: Recorded at 24 hours postoperatively and at a follow-up phone call after discharge.
Other outcomes:
Locations:
city: Tekirdağ
country: Turkey
facility: Tekirdag Namik Kemal University
Study officials:
affiliation: Namik Kemal University
name: Onur Baran
role: STUDY_CHAIR
References: