SPSIP Block and Opioid Use After MICS (NCT07259824) | Clinical Trial Compass
CompletedNot Applicable
SPSIP Block and Opioid Use After MICS
Turkey (Türkiye)50 participantsStarted 2026-01-22
Plain-language summary
This prospective, randomized, controlled, single-center clinical study aims to evaluate the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in perioperative pain management among patients undergoing minimally invasive cardiac surgery (MICS). A total of 50 patients undergoing MICS will be randomized into two groups: one receiving standard analgesia plus ultrasound-guided SPSIPB with 30 mL of 0.25% bupivacaine, and a control group receiving standard analgesia only. The primary outcome is total postoperative opioid consumption within 24 hours. Secondary outcomes include postoperative pain scores, extubation time, block-related complications, and recovery parameters such as early mobilization, oral intake, Modified radiological atelectasis score and Quality of Recovery-15 scores.
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:
* Patients scheduled for elective minimally invasive cardiac surgery (MICS)
* Age between 18 and 75 years
* American Society of Anesthesiologists (ASA) physical status II-III
* Body mass index (BMI) between 18 and 35 kg/m²
* Patients who provide written informed consent for participation
Exclusion Criteria:
* Known allergy or hypersensitivity to local anesthetics
* Coagulopathy or current anticoagulant therapy
* Pregnancy or breastfeeding
* Impaired consciousness or inability to communicate
* Failed or technically inadequate block
* Refusal to undergo the block procedure
* Cognitive or mental disorders preventing valid pain assessment
* Opioid intolerance or contraindication to opioid use
* Development of intraoperative or postoperative complications requiring reoperation, prolonged mechanical ventilation, or intensive care
* Incomplete postoperative data or patient withdrawal from the study
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
Total opioid consumption within 24 hours after surgery