This randomized, double-blind, placebo-controlled study aims to evaluate the effect of the serratus posterior superior intercostal plane (SPSIP) block on postoperative pain and opioid consumption in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy.
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy. Postoperative pain following thoracic cardiac surgery may impair respiratory function and delay recovery, making effective analgesia essential. Participants will be randomly assigned to receive an ultrasound-guided SPSIP block with either bupivacaine or normal saline under identical conditions. All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Blinding will be ensured for patients and outcome assessors. The study aims to determine whether SPSIP block with local anesthetic reduces postoperative opioid consumption and improves pain control compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia.
Participants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia.
Fatma Acil
Diyarbakır, Outside of the US, Turkey (Türkiye)
RECRUITING24-hour cumulative opioid consumption
Total opioid consumption within the first 24 hours after surgery, expressed as intravenous morphine milligram equivalents (IV-MME).
Time frame: 24 hours after surgery
Postoperative pain intensity at rest (NRS)
Pain intensity at rest measured using the Numeric Rating Scale (0-10).
Time frame: 4, 6, 12, and 24 hours after surgery
Postoperative pain during movement (NRS)
Pain intensity during coughing or deep breathing measured using the Numeric Rating Scale (0-10).
Time frame: 4, 6, 12, and 24 hours after surgery
Time to first rescue analgesia
Time from the end of surgery to the first administration of rescue analgesia.
Time frame: Within 24 hours after surgery
Time to extubation
Time from the end of surgery to extubation.
Time frame: From the end of surgery until extubation, assessed up to 24 hours
Length of intensive care unit stay
Duration of stay in the intensive care unit.
Time frame: Through study completion, an average of 48 hours
Length of hospital stay
Total duration of hospitalization.
Time frame: From date of admission until discharge, up to 30 days
Inspiratory Spirometry Test
Inspiratory spirometry performance will be assessed using an incentive spirometer. Inspiratory capacity will be estimated based on the number of rising balls: 1 ball = 600 mL, 2 balls = 900 mL, and 3 balls = 1200 mL. The score ranges from a minimum of 1 ball to a maximum of 3 balls, with higher scores indicating better inspiratory function.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 4, 6, 12, and 24 hours after surgery