Serratus Posterior Superior Plane Block in Minimally Invasive Cardiac Surgery (NCT07420712) | Clinical Trial Compass
RecruitingNot Applicable
Serratus Posterior Superior Plane Block in Minimally Invasive Cardiac Surgery
Turkey (Türkiye)60 participantsStarted 2025-07-01
Plain-language summary
This prospective randomized controlled trial aims to evaluate the effectiveness of the serratus posterior superior intercostal plane block (SPSIPB) as part of a multimodal analgesia strategy in patients undergoing minimally invasive cardiac surgery. Sixty adult ASA III patients scheduled for minimally invasive coronary artery bypass surgery will be randomly assigned to either an SPSIPB group or a control group receiving standard analgesic management without a plane block. The primary outcome is postoperative opioid (tramadol) consumption, while secondary outcomes include intraoperative remifentanil consumption, pain scores at rest and during coughing, time to first rescue analgesia, time to extubation, and lengths of intensive care unit and hospital stay.
All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia. Pain intensity will be assessed using the Numeric Rating Scale at predefined postoperative intervals. Postoperative complications such as nausea, vomiting, and atelectasis will be recorded. This study aims to determine whether SPSIPB provides effective opioid-sparing analgesia and improves postoperative recovery parameters in minimally invasive cardiac surgery.
Who can participate
Age range
18 Years – 75 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:
* Adults aged 18 years or older
* American Society of Anesthesiologists (ASA) physical status III
* Scheduled for elective minimally invasive coronary artery bypass surgery
* Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
* Age under 18 years
* ASA physical status other than III
* Pregnancy
* Emergency surgery
* History of trauma within the previous 24 hours
* Neurological disorders affecting consciousness or decision-making capacity
* Psychiatric disorders affecting decision-making capacity or cooperation
* Known allergy to local anesthetic agents
* Infection or skin disease at the block injection site
* Body mass index greater than 35 kg/m²
* Body weight less than 42 kg
* Coagulation disorders (international normalized ratio \>1.25, activated partial thromboplastin time \>35 seconds, or platelet count \<100,000/µL)
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 Opioid Consumption
Timeframe: Within the first 24 hours after surgery
Trial details
NCT IDNCT07420712
SponsorKartal Kosuyolu High Speciality Training and Research Hospital