Clinical Trial

Serratus Posterior Superior Intercostal Plane Block in Cardiac Implantable Electronic Device Implantation

Completed
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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.
Protocol Amendment History 1 change
critical Trial completed 2026-05-02
Trial Details
NCT Number NCT07165041
Lead Sponsor Gozde Altun
Conditions Pain, Postoperative
Enrollment 60 participants
Start Date 2025-06-30
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-04-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-11