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Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation

NCT07739407 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-07-31

No results posted yet for this study

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

Interventions

OTHER

Ultrasound-Guided PECS II Block

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.

OTHER

Standard Local Infiltration Anesthesia

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.

Sponsors & Collaborators

  • ferdi gülaştı

    lead OTHER

Principal Investigators

  • Ferdi Gulasti · Aydın Adnan Menderes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-05
Primary Completion
2027-08-05
Completion
2027-08-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07739407 on ClinicalTrials.gov