CompletedNot Applicable

Comparing the Efficacy of Ultrasound Guided Erector Spinae Plane Block, Ultrasound Guided Caudal Block, and Local Infiltration for Postoperative Pain Control in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair as a Day-Case Surgeries: A Randomized Controlled Trial

Egypt75 participantsStarted 2025-01-20

Plain-language summary

The aim of this study is to evaluate the efficacy of ultrasound guided Erector block versus caudal block versus local wound infiltration perioperatively according to: Primary outcome: to assess and compare the postoperative analgesic effect using pain score: Faces Legs Activity Cry Consolability tool (FLACC, 0- 10) at 15 min, 30 min and 1, 2, 3 and 4 h after operation Secondary outcomes: First dose of fentanyl as a rescue analgesia in dose of 0.5 μg/kg. Total doses of fentanyl as a rescue analgesia. Demographic data: age, sex, weight, ASA class. Hemodynamic parameter (MAP in (mm/hg) and heart rate (beats/minute)) Motor function will be assessed using the following scale: 0, no motor block; 1, able to move legs; 2, unable to move legs. Assessment of sedation will be done with objective score based on eye opening: 0- spontaneously, 1- on verbal stimulation, 2- on physical stimulation Adverse events: bradycardia, hypotension, respiratory depression, local anesthesia toxicity, subarachnoid injection in caudal block, PONV, agitation, or urinary catheterization.

Who can participate

Age range

24 Months – 84 Months

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: \- Inclusion Criteria: pediatric patients of both sexes undergoing elective unilateral inguinal hernia surgeries aged from 2 year to 7 years belonging to ASA I or II. Exclusion Criteria: Parents refusal. Coagulopathy. Allergy to local anesthesia. Local infection at the site of injection. Neurological anomalies. Exclusion Criteria: \-

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

Faces Legs Activity Cry Consolability tool (FLACC, 0- 10) at 15 min, 30 min and 1, 2, 3 and 4 h after operation

Timeframe: 4 hours

Trial details

NCT IDNCT06849804

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-10

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