Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation

Sponsor
ferdi gülaştı
Study ID
NCT07739407
Status
Not Yet Recruiting

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Conditions

  • Cardiac Pacing
  • Permanent Pacemaker Implantation
  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jul 31, 2026
Start date
Aug 5, 2026
Status verified
Jul 2026
Primary completion
Aug 5, 2027
Completion
Aug 5, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PECS II Block + Standard Local Infiltration
    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
  • Active Comparator: Standard Local Infiltration
    Participants will receive standard local infiltration anesthesia with 1% lidocaine during elective permanent pacemaker implantation without PECS II block.

Primary Outcome Measure

Pain intensity during pacemaker pocket creation measured by the Numerical Rating Scale (NRS, 0-10) [ Time Frame: During pacemaker pocket creation (intraoperative assessment) ]

Central Contacts

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