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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:
Primary Outcome:
Secondary Outcomes:
The study aims to determine which regional anesthesia technique provides superior pain relief and reduces systemic analgesic requirements in pediatric patients.
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:
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:
Secondary Outcomes:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Intraoperative Hemodynamic Stability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Onur Baran | Namik Kemal University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tekirdag Namik Kemal University | Tekirdağ | Turkey (Türkiye) |
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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.
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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.
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| 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. |
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| 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 |
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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. |
| 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. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000763 | Anesthesia, Caudal |
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D000767 | Anesthesia, Epidural |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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