NOT YET RECRUITING
NCT07882836
Bilateral Pecto-Intercostal Fascial Plane Block for Prevention of Chronic Poststernotomy Pain After CABG
This single-center, prospective, parallel-group randomized controlled trial will evaluate whether adding ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) to standard multimodal systemic analgesia reduces the incidence of clinically significant chronic poststernotomy pain in adults undergoing elective isolated coronary artery bypass grafting (CABG) through median sternotomy.
A total of 180 eligible participants will be randomized in a 1:1 ratio to either standard general anesthesia with standardized multimodal systemic analgesia alone or the same perioperative analgesic regimen with the addition of bilateral PIFB performed after induction of general anesthesia and before surgical incision. In the PIFB group, 15 mL of 0.25% bupivacaine will be administered on each side under ultrasound guidance. Perioperative anesthesia, systemic analgesia, rescue analgesia, intensive care management, and routine postoperative care will otherwise be standardized between groups.
The primary outcome will be the proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90. This outcome will be defined as pain that develops or worsens after surgery, is localized to the sternotomy line or related thoracic surgical areas, persists or recurs at 3 months, has an average intensity of at least 3 on a 0-10 Numeric Rating Scale during the preceding 7 days, and is not better explained by another clinical condition.
Secondary outcomes will include early postoperative pain intensity, acute pain burden, opioid consumption, rescue analgesic requirements, time to first rescue analgesia, postoperative nausea and vomiting, time to extubation, duration of mechanical ventilation, intensive care unit and hospital length of stay, and persistent postoperative pain at day 30. Participants will be followed through postoperative day 90.
Gender: All
Ages: 18 Years - 80 Years
Chronic Poststernotomy Pain