Serratus Posterior Superior Intercostal Plane Block in Cardiac Implantable Electronic Device Implantation (SPSIPB-CIED)

June 9, 2026 updated by: Gozde Altun

Efficacy of Serratus Posterior Superior Intercostal Plane Block in Cardiac Implantable Electronic Device Implantation: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • An established history of chronic pain, or diagnosed sleep disorders requiring active treatment (e.g., obstructive sleep apnea syndrome, insomnia)
  • Local infection at injection site
  • Psychiatric or neurologic disorders interfering with pain/sleep assessment
  • Revision or replacement CIED implantation (not first-time)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPSIP Block
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
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 Comparator: Sham Control
Sham procedure with 1 mL saline injection at the same anatomical site, without administration of local anesthetic, prior to CIED implantation.
Procedure: Sham procedure
Sham procedure with 1 mL saline injection at the same anatomical site, without administration of local anesthetic, prior to CIED implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain intensity assessed by Visual Analog Scale (VAS)
Time Frame: Intraoperative and postoperative at 3, 6, 12, and 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality assessed by Sleep Quality Numeric Rating Scale (SQ-NRS)
Time Frame: 24 hours after surgery
Sleep quality will be measured using the SQ-NRS, scored from 0 = excellent sleep to 10 = worst possible sleep. A score ≥6 indicates poor sleep quality.
24 hours after surgery
Patient satisfaction with procedure
Time Frame: 24 hours after surgery
Patients will rate their satisfaction with the procedure on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
24 hours after surgery
Clinician satisfaction with procedure
Time Frame: 24 hours after surgery
Clinicians performing the procedure will rate their satisfaction on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gozde Altun

Investigators

  • Study Director: Kerem Erkalp, MD, Istanbul University-Cerrahpasa, Cardiology Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2025

Primary Completion (Actual)

April 1, 2026

Study Completion (Actual)

April 8, 2026

Study Registration Dates

First Submitted

September 2, 2025

First Submitted That Met QC Criteria

September 2, 2025

First Posted (Actual)

September 10, 2025

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1395253

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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