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

NCT ID: NCT07165041

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-02-10

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.

Detailed Description

Cardiac implantable electronic device (CIED) implantation is a common procedure for the management of arrhythmias and prevention of sudden cardiac death. Although routinely performed under local anesthesia, patients may experience intraoperative and postoperative pain, which can affect hemodynamic stability, recovery, and satisfaction. Effective perioperative analgesia is therefore critical in this patient group, who often present with multiple comorbidities and advanced age. Conventional systemic analgesics may be insufficient or associated with side effects, highlighting the need for alternative approaches.

The serratus posterior superior intercostal plane block (SPSIPB) is a recently described regional anesthesia technique targeting the interfascial plane between the rhomboid major and serratus posterior superior muscles. Previous studies have shown its efficacy in thoracic, breast, clavicular, and minimally invasive cardiac surgeries. However, its role in the context of CIED implantation has not been systematically studied.

This study is designed as a prospective, double-blind, randomized controlled trial. A total of 60 patients scheduled for first-time CIED implantation will be randomized into two groups: the intervention group (SPSIPB with 30 mL 0.25% bupivacaine) and the control group (sham injection with 1 mL saline). All procedures will be performed under standard local anesthesia. The primary outcome is perioperative pain assessed by VAS intraoperatively and at 3, 6, 12, and 24 hours postoperatively. Secondary outcomes include postoperative sleep quality (SQ-NRS) and both patient and clinician satisfaction (5-point Likert scale). The trial will provide evidence regarding the potential of SPSIP block to improve perioperative analgesia and patient-centered outcomes in CIED implantation.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SPSIP Block

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

Group Type: EXPERIMENTAL

SPSIP Block

Intervention Type: 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.

Sham Control

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

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: PROCEDURE

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

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.

Intervention Type: PROCEDURE

Sham procedure

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

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gozde Altun

OTHER

Sponsor Role: lead

Responsible Party

Gozde Altun

Lecturer, Department of Anesthesiology and Reanimation, Istanbul University-Cerrahpasa, Cardiology Institute

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kerem Erkalp, MD

Role: STUDY_DIRECTOR

Istanbul University-Cerrahpasa, Cardiology Institute

Locations

Gozde Altun

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Gözde Altun, MD

Role: CONTACT

drgozdetzvr@hotmail.com

+905544290333

Şükrü ARSLAN, MD

Role: CONTACT

sukru.arslan@iuc.edu.tr

+905556232606

Facility Contacts

Gozde Altun, MD

Role: primary

gozde.altun@iuc.edu.tr

+905544290333

References

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.

Reference Type: RESULT

PMID: 36883093 (View on PubMed)

Other Identifiers

1395253

Identifier Type: -

Identifier Source: org_study_id