CompletedNot Applicable

Ultrasound-Guided Serratus Anterior Plane Block Versus Erector Spinae Plane Block in Pediatric Cardiac Surgery

Egypt64 participantsStarted 2022-07-24

Plain-language summary

Background and Objectives: Opioid based analgesia is the main used technique in pediatric cardiac surgery which preclude fast-track recovery. Ultrasound guided regional fascial plane blocks are used recently in many pediatric surgical procedure with excellent outcomes and very low rate of complication. The investigators will compare ultrasound guided serratus anterior plane block and erector spinae plane block in pediatric cardiac surgical procedure through thoracotomy approach regarding effectiveness of postoperative analgesia, incidence of complications and effect in ultrafast track recovery. Methods: The investigators will enroll 64 pediatric patients aged from 6 months to 10 years undergoing cardiac surgical procedure through thoracotomy approach either with or without cardiopulmonary bypass in this prospective randomized study. After induction of general anesthesia, the patients will be randomly assigned into 2 groups based regional fascial plane block given (SAP group will receive ultrasound guided single shot serratus anterior plane block and ESP group will receive ultrasound guided single shot erector spinae plane block). The effectiveness of postoperative analgesia using FLACC pain score will be recorded as the primary outcome while total consumption of analgesics, the time for rescue analgesia, incidence of complications, and incidence of need for re-intubation will be recorded as the secondary outcomes.

Who can participate

Age range

6 Months – 10 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: * ASA physical status II-III. * Age between 6 months and 10 years old, * of both sexes, * undergoing cardiac surgical procedure through thoracotomy approach either with or without cardiopulmonary bypass e.g. ASD closure, PDA ligation, and aortic coarctation repair. Exclusion Criteria: * Patients weight less than 5 kg, * Patients with coagulopathy, * previous cardiac surgery, * emergency procedure, * previous thoracotomy or sternotomy, * surgery through sternotomy incision, * patients with complex surgical repair, * patients need postoperative mechanical ventilation. * hypersensitivity to local anesthetics, * infection at site of block injection, * parent or guardian refusal.

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

Effectiveness of postoperative analgesia

Timeframe: 6 months

Trial details

NCT IDNCT05526469

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-31

View on ClinicalTrials.gov More Congenital Heart Disease trials