CompletedNot Applicable

Serratus Anterior Plane Block Versus Standard of Care After Totally Endoscopic Aortic Valve Replacement

Belgium80 participantsStarted 2020-12-03

Plain-language summary

The aim of this study is to assess and compare the efficacy of a serratus anterior plane (SAP) block and our current pain protocol (Patient Controlled Intravenous Analgesia with opioids) in the prevention and treatment of acute postoperative pain after totally endoscopic aortic valve replacement (AVR) surgery.

Who can participate

Age range

18 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: * Scheduled for elective aortic valve replacement surgery via right anterolateral thoracotomy * Adult patients (minimally 18 years old) * EuroScore ii \< 3% * Bodyweight \> 50 kg Exclusion Criteria: * Refusal to participate * Inability to communicate due to language or neurologic barriers * Inability to control and self-administer opioids with PCIA or to comprehend the NRS pain score due to confusion or learning difficulties * Chronic use of opioids * Chronic use of analgesic antidepressants and/or antiepileptics * History of major trauma or surgery to right chest wall * History of chronic pain at right chest wall * Allergy to opioids and/or local anesthetics * Allergy to acetaminophen * Morbid obesity (BMI \> 35) * Pregnancy * Peroperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, ..)

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

Cumulative opioid consumption by patient-controlled intravenous analgesia (PCIA)

Timeframe: 24 hours after performing the SAP block

Trial details

NCT IDNCT04699422

SponsorJessa Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-04

View on ClinicalTrials.gov More Analgesia trials