Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation

NCT07739407 | Not Yet Recruiting

• 1 other identifier: 2026/194-28
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-center, prospective, randomized, controlled clinical trial aims to evaluate whether ultrasound-guided PECS II block, when added to standard local infiltration anesthesia, improves perioperative analgesia in patients undergoing elective permanent pacemaker implantation. Seventy-two adult patients scheduled for elective permanent pacemaker implantation will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided PECS II block plus standard local infiltration anesthesia or standard local infiltration anesthesia alone. The primary outcome is pain intensity during pacemaker pocket creation measured using the Numerical Rating Scale (NRS). Secondary outcomes include intraoperative pain scores, additional local anesthetic, opioid and sedative requirements, postoperative pain scores, analgesic consumption during the first 24 hours, patient and operator satisfaction, procedure duration, and procedure-related complications. The study is designed to determine whether PECS II block provides additional analgesic benefit during permanent pacemaker implantation.

Conditions

Cardiac Pacing; Permanent Pacemaker Implantation; Postoperative Pain

Keywords

PECS II Block; Permanent Pacemaker; Local Infiltration Anesthesia; Perioperative Analgesia; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Pain intensity during pacemaker pocket creation measured by the Numerical Rating Scale (NRS, 0-10)

  Pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary endpoint is the NRS pain score recorded during pacemaker pocket creation.

  During pacemaker pocket creation (intraoperative assessment)

Study Arms (2)

PECS II Block + Standard Local Infiltration

EXPERIMENTAL

Participants will receive an ultrasound-guided PECS II block with 20 mL of 0.25% bupivacaine before the procedure, followed by standard local infiltration anesthesia with 1% lidocaine during elective permanent pacemaker implantatio

Other: Ultrasound-Guided PECS II Block; Other: Standard Local Infiltration Anesthesia

Standard Local Infiltration

ACTIVE COMPARATOR

Participants will receive standard local infiltration anesthesia with 1% lidocaine during elective permanent pacemaker implantation without PECS II block.

Other: Standard Local Infiltration Anesthesia

Interventions

Ultrasound-Guided PECS II Block OTHER

Ultrasound-guided PECS II block will be performed before permanent pacemaker implantation using 20 mL of 0.25% bupivacaine. The local anesthetic will be injected between the pectoralis major and pectoralis minor muscles and between the pectoralis minor and serratus anterior muscles under ultrasound guidance.

PECS II Block + Standard Local Infiltration

Standard Local Infiltration Anesthesia OTHER

Standard local infiltration anesthesia will be administered by the implanting physician using 1% lidocaine at the incision site and pacemaker pocket according to routine clinical practice.

PECS II Block + Standard Local Infiltration; Standard Local Infiltration

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Scheduled for elective permanent pacemaker implantation.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

• Infection at the planned block site.
• Known allergy or hypersensitivity to local anesthetics.
• Uncorrected coagulopathy or active bleeding disorder.
• Contraindication to PECS II block because of anticoagulant or antiplatelet therapy.
• Severe cognitive impairment or inability to use the Numerical Rating Scale (NRS).
• Emergency pacemaker implantation.
• Planned generator replacement, lead revision, or device revision procedure.
• Anatomical abnormalities preventing safe block performance.
• Refusal to participate in the study.

Sponsors & Collaborators

• ferdi gülaştı: lead

Related Publications (1)

• Kilin M, Kavakli AS, Karaveli A, Sugur T, Kus G, Cagirci G, Arslan S. PECS II block for cardiac implantable electronic device insertion: A pilot study. Pacing Clin Electrophysiol. 2023 Oct;46(10):1251-1257. doi: 10.1111/pace.14811. Epub 2023 Sep 4.

  PMID: 37665000 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ferdi Gulasti

  Aydın Adnan Menderes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferdi Gulasti, MD

CONTACT

+905054929650; ferdigulasti@gmail.com

SEVİL GÜLAŞTI, MD

CONTACT

drsevilonay@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist performing the PECS II block will not be blinded because of the nature of the intervention. Participants and the implanting physician will be aware of the assigned treatment. However, investigators responsible for postoperative pain assessment, patient satisfaction evaluation, data collection, and statistical analysis will remain blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Aydin Adnan Menderes University Faculty of Medicine

Model Details: Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided PECS II block plus standard local infiltration anesthesia (intervention group) or standard local infiltration anesthesia alone (control group). Outcomes will be compared between the two parallel groups during and after elective permanent pacemaker implantation.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): August 5, 2027
• Study Completion (Estimated): August 5, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07