Cardiac PacingPACE-PECSNCT07739407
Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation
A study testing Ultrasound-Guided PECS II Block and Standard Local Infiltration Anesthesia in people with Cardiac Pacing and Permanent Pacemaker Implantation, run by ferdi gülaştı.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacing, Permanent Pacemaker Implantation, Postoperative Pain
- What is being tested?
- Ultrasound-Guided PECS II Block and Standard Local Infiltration Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2026to 5 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Planned generator replacement, lead revision, or device revision procedure.
- Anatomical abnormalities preventing safe block performance.
- Refusal to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
SEVİL GÜLAŞTI, MD contact
About this study
Official title: The Contribution of Ultrasound-Guided PECS II Block to Standard Local Infiltration Anesthesia During Elective Permanent Pacemaker Implantation: A Prospective Randomized Controlled Trial
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.
Read the detailed description
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
- Being tested
- Ultrasound-Guided PECS II Block, Standard Local Infiltration Anesthesia
- Keywords
- PECS II Block, Permanent Pacemaker, Local Infiltration Anesthesia, Perioperative Analgesia, Randomized Controlled Trial
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided PECS II BlockOther
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 AnesthesiaOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Standard Local Infiltration Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During pacemaker pocket creation (intraoperative assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start5 Aug 2026 (estimated)
- Primary completion5 Aug 2027 (estimated)
- Study completion5 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac PacingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ferdi gülaştı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ferdi gülaştı, Aydin Adnan Menderes University
- Investigators
- Ferdi Gulasti, Principal investigator, Aydın Adnan Menderes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739407
- Sponsor's protocol ID
- 2026/194-28
- Acronym
- PACE-PECS
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37665000
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Ultrasound-Guided PECS II Block to Standard Local Infiltration Anesthesia During Elective Permanent Pacemaker Implantation: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07739407
- Acronym / sponsor ID
- PACE-PECS / 2026/194-28
- Keywords
- PECS II Block, Permanent Pacemaker, Local Infiltration Anesthesia, Perioperative Analgesia, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- ferdi gülaştıUniversity, hospital or other
- Study start
- 5 Aug 2026 (estimated)
- Primary completion
- 5 Aug 2027 (estimated)
- Study completion
- 5 Aug 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PECS II Block + Standard Local Infiltration | Experimental | Other: Ultrasound-Guided PECS II Block, Other: Standard Local Infiltration AnesthesiaParticipants 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 |
| Standard Local Infiltration | Active comparator | Other: Standard Local Infiltration AnesthesiaParticipants will receive standard local infiltration anesthesia with 1% lidocaine during elective permanent pacemaker implantation without PECS II block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided PECS II BlockUltrasound-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 | PECS II Block + Standard Local Infiltration |
| Standard Local Infiltration AnesthesiaStandard 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. | Other | PECS II Block + Standard Local Infiltration, Standard Local Infiltration |
Primary outcome
Pain intensity during pacemaker pocket creation measured by the Numerical Rating Scale (NRS, 0-10)
Time frame: During pacemaker pocket creation (intraoperative assessment)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Results publication: PubMed 37665000Kilin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SEVİL GÜLAŞTI, MD contact
Ferdi Gulasti principal investigator
Aydın Adnan Menderes University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided PECS II Block and Standard Local Infiltration Anesthesia in people with Cardiac Pacing and Permanent Pacemaker Implantation, run by ferdi gülaştı.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ferdi Gulasti, MD (+905054929650, ferdigulasti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07739407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.