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NCT Number: NCT07165041

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gozde Altun

Istanbul, 34098, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Sham Procedure

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Gozde Altun

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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