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

NCT07165041 | Completed DMC

• 1 other identifier: 1395253
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Keywords

Serratus Posterior Superior Intercostal Plane Block; Cardiac Implantable Electronic Device; Pain Management; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity assessed by Visual Analog Scale (VAS)

  Pain levels will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no pain and 10 = worst imaginable pain. Scores will be recorded intraoperatively and at 3h, 6h, 12h, and 24h postoperatively.

  Intraoperative and postoperative at 3, 6, 12, and 24 hours

Secondary Outcomes (3)

• Sleep quality assessed by Sleep Quality Numeric Rating Scale (SQ-NRS)

  24 hours after surgery

• Patient satisfaction with procedure

  24 hours after surgery

• Clinician satisfaction with procedure

  24 hours after surgery

Study Arms (2)

SPSIP Block

EXPERIMENTAL

Ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block performed with 30 mL of 0.25% bupivacaine administered prior to CIED implantation

Procedure: SPSIP Block

Sham Control

SHAM COMPARATOR

Sham procedure with 1 mL saline injection at the same anatomical site, without administration of local anesthetic, prior to CIED implantation.

Procedure: Sham procedure

Interventions

SPSIP Block PROCEDURE

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.

SPSIP Block

Sham procedure PROCEDURE

Sham procedure with 1 mL saline injection at the same anatomical site, without administration of local anesthetic, prior to CIED implantation.

Sham Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gozde Altun: lead

Study Sites (1)

Gozde Altun

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (1)

• Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.

  PMID: 36883093 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Kerem Erkalp, MD

  Istanbul University-Cerrahpasa, Cardiology Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, and outcome assessors will be blinded to group allocation. The block (bupivacaine or sham saline) will be prepared and administered by an anesthesiologist not involved in outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, Department of Anesthesiology and Reanimation, Istanbul University-Cerrahpasa, Cardiology Institute

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with local anesthetic or a sham injection with saline. The study is designed as a prospective, double-blind, parallel-group randomized controlled trial.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: June 30, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 8, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

TU (1)