Caudal Epidural Vs. TAP Block for Postoperative Analgesia in Pediatric Infraumbilical Surgery: a RCT (NCT06895382) | Clinical Trial Compass
CompletedNot Applicable
Caudal Epidural Vs. TAP Block for Postoperative Analgesia in Pediatric Infraumbilical Surgery: a RCT
Turkey (Türkiye)60 participantsStarted 2022-12-15
Plain-language 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.
Who can participate
Age range
1 Year – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative FLACC Pain Scores
Timeframe: FLACC pain scores were recorded at 2, 6, 12, and 24 hours postoperatively