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Completed
NCT07420712
Serratus Posterior Superior Plane Block in Minimally Invasive Cardiac Surgery
Conditions: Analgesia
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 22
Sponsor: Kartal Kosuyolu High Speciality Training and Research Hospital
Location: Kosuyolu High Specialization Training and Research Hospital Istanbul
Summary
This prospective randomized controlled trial aimed to evaluate the efficacy of serratus posterior superior intercostal plane block (SPSIPB) as a component of a multimodal analgesia strategy for postoperative pain control, opioid consumption, and hemodynamic response in patients undergoing mini-thoracotomy cardiac surgery. The study was planned to include a total of 60 patients, with 30 patients in each group. Patients with ASA physical status I-III scheduled for elective mini-thoracotomy cardiac surgery (coronary artery bypass grafting, valve replacement, atrial septal defect closure, or beating-heart bypass) will be randomized to the SPSIPB group or a control group receiving standard analgesic management without any regional block. The primary outcome is the resting Numeric Rating Scale (NRS) pain score at 1 hour postoperatively. Secondary outcomes include resting and movement (passive shoulder flexion) NRS pain scores at 1, 4, 8, 16, and 24 hours, cumulative 24-hour tramadol consumption, proportion of patients requiring rescue analgesia, intraoperative remifentanil consumption, systolic blood pressure change at incision, incidence of postoperative nausea and vomiting (PONV), patient satisfaction (5-point Likert scale), time to extubation, and intensive care unit length of stay.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older
* American Society of Anesthesiologists (ASA) physical status I - 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 I - 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 \
Source: ClinicalTrials.gov (NCT07420712). StuddyBuddy aggregates publicly available trial information.