Efficacy of Serratus Posterior Superior Intercostal Plane Block in Cardiac Device Implantation

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.

Eligibility

Inclusion Criteria:

* Adults ≥18 years of age
* Scheduled for first-time cardiac implantable electronic device (CIED) implantation (pacemaker or ICD)
* Able to provide written informed consent
* Normal coagulation profile
* No local infection at the planned block site

Exclusion Criteria:

* Severe heart failure (NYHA class IV)
* Morbid obesity (BMI \>35 kg/m²)
* Known allergy to local anesthetics (e.g., bupivacaine)
* Coagulopathy or ongoing anticoagulant therapy contraindicating regional block
* Local infection at injection site
* Psychiatric or neurologic disorders interfering with pain/sleep assessment
* Revision or replacement CIED implantation (not first-time)

Conditions2

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