Erector Spinae Plane Block (ESP) vs Serratus Anterior Plane Block (SAP) for Loco-Regional Analges… (NCT07433114) | Clinical Trial Compass
CompletedNot Applicable
Erector Spinae Plane Block (ESP) vs Serratus Anterior Plane Block (SAP) for Loco-Regional Analgesia in Adult Patients Undergoing Minimally Invasive Cardiac Surgery Via Mini-Thoracotomy: Impact on Morphine Consumption, Pain Control, and Quality of Recovery
Italy57 participantsStarted 2025-03-05
Plain-language summary
Optimization of postoperative analgesia and reduction of opioid consumption are key components of Enhanced Recovery After Surgery (ERAS) protocols in cardiac surgery. Although intravenous opioids have traditionally been the mainstay of analgesic management due to their potent analgesic effect and hemodynamic stability, high-dose opioid use has been associated with respiratory depression, prolonged mechanical ventilation, delayed extubation, longer intensive care unit stay, and multiple short- and long-term adverse effects.
Thoracic wall loco-regional anesthesia techniques represent promising opioid-sparing strategies in minimally invasive cardiac surgery performed via mini-thoracotomy.
The purpose of this prospective randomized study is to compare two loco-regional analgesic techniques - the Erector Spinae Plane (ESP) block and the Serratus Anterior Plane (SAP) block - in adult patients undergoing minimally invasive cardiac surgery.
The study aims to determine whether one technique is superior in reducing postoperative morphine consumption, improving pain control, and enhancing patient-reported quality of recovery as measured by the Italian Quality of Recovery (iQoR) questionnaire.
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:
* Patients over 18 years of age undergoing cardiac surgery via a mini thoracotomy approach
* patient agreement to participate in the protocol and sign the informed consent.
Exclusion Criteria:
* patients with psychiatric disorders
* patients who have already undergone surgery involving the chest wall
* patients suffering from chronic pain already undergoing home therapy
* allergy to NSAIDs/paracetamol
* absence of informed consent
* participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the five half-lives of the study drug (whichever is longer)
* pregnant women.
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
Subjective quality of the postoperative period
Timeframe: From the Day of Surgery for the Following 48 Hours.
Trial details
NCT IDNCT07433114
SponsorAzienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano