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Efficacy of Serratus Posterior Superior Intercostal Plane Block in Cardiac Device Implantation
Sponsor: Gozde Altun
Summary
This randomized controlled clinical trial investigates the efficacy of the serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing cardiac implantable electronic device (CIED) implantation. Participants will be randomized to receive either SPSIP block with local anesthetic or a sham procedure with saline injection. Pain intensity will be evaluated intraoperatively and at 3, 6, 12, and 24 hours postoperatively using the Visual Analog Scale (VAS). Secondary outcomes include sleep quality at 24 hours assessed with the Sleep Quality Numeric Rating Scale (SQ-NRS), and patient and clinician satisfaction assessed with a 5-point Likert scale. The study is designed as prospective, double-blind, and parallel-group, aiming to improve perioperative pain management in CIED procedures.
Official title: Efficacy of Serratus Posterior Superior Intercostal Plane Block in Cardiac Implantable Electronic Device Implantation: A Prospective, Double-Blind, Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-06-30
Completion Date
2026-04-08
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
SPSIP Block
Ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block performed prior to cardiac implantable electronic device (CIED) implantation. A total of 30 mL of 0.25% bupivacaine will be injected into the interfascial plane between the rhomboid major and serratus posterior superior muscles under sterile conditions.
Sham procedure
Sham procedure with 1 mL saline injection at the same anatomical site, without administration of local anesthetic, prior to CIED implantation.
Locations (1)
Gozde Altun
Istanbul, Turkey (Türkiye)