An interventional study of Ultrasound-Guided PECS II Block and Standard Local Infiltration Anesthesia in Cardiac Pacing, Permanent Pacemaker Implantation and Postoperative Pain, sponsored by ferdi gülaştı. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by ferdi gülaştı · Not applicable, Interventional, and Treatment
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.
Permanent pacemaker implantation is commonly performed under local infiltration anesthesia; however, patients may still experience significant pain during skin incision, pocket creation, and generator placement, frequently requiring supplemental local anesthetics, opioids, or sedatives. Ultrasound-guided PECS II block has recently emerged as a promising regional anesthesia technique for cardiac implantable electronic device procedures by providing sensory blockade of the anterior chest wall.
This investigator-initiated, single-center, prospective, parallel-group, randomized controlled trial will compare ultrasound-guided PECS II block combined with standard local infiltration anesthesia with standard local infiltration anesthesia alone in patients undergoing elective permanent pacemaker implantation.
A total of 72 adult patients will be randomized in a 1:1 ratio into two treatment groups. Patients assigned to the intervention group will receive an ultrasound-guided PECS II block with 20 mL of 0.25% bupivacaine before the procedure, followed by standard local infiltration anesthesia. Patients in the control group will receive standard local infiltration anesthesia alone. Rescue analgesia and light sedation will be administered only when clinically required according to a predefined protocol.
The primary endpoint is the Numerical Rating Scale (NRS, 0-10) pain score during pacemaker pocket creation. Secondary endpoints include the highest intraoperative pain score, pain scores at different procedural stages and during the first 24 postoperative hours, total intraoperative local anesthetic consumption, additional opioid and sedative requirements, postoperative analgesic consumption, patient and operator satisfaction, procedure duration, block performance time, and procedure-related complications.
The study is expected to provide evidence regarding the effectiveness of ultrasound-guided PECS II block as an adjunct to standard local infiltration anesthesia for improving perioperative pain control and reducing additional analgesic requirements during elective permanent pacemaker implantation
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 72 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
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
Participants will receive standard local infiltration anesthesia with 1% lidocaine during elective permanent pacemaker implantation without PECS II block.
Other: Standard Local Infiltration Anesthesia
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 will be administered by the implanting physician using 1% lidocaine at the incision site and pacemaker pocket according to routine clinical practice.
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.
Time frame: During pacemaker pocket creation (intraoperative assessment)
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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