Cardiac Implantable Electronic DeviceNCT05528627
PECs for Implantable Cardiac Electronic Device Insertion
A study testing Pectoral Nerve (PECs) block in people with Cardiac Implantable Electronic Device and Nerve Block, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the feasibility of the Pectoralis Nerve (PECS) block for CIED insertion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Implantable Electronic Device, Nerve Block, Anesthesia
- What is being tested?
- Pectoral Nerve (PECs) block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiologists grade II-IV patients
- in the age group of 18-80 years,
- Patients undergoing CIED insertion
Who cannot join
- pre-existing infection at the block site,
- coagulopathy,
- morbid obesity (Body mass index >35 kg m-2 ),
- allergy to local anaesthetics,
- decreased pulmonary reserve,
- psychiatric illness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya
About this study
Official title: Evaluation of the Efficacy of Pectoral Nerve (PECs) Blocks in Patients Undergoing Cardiac Implantable Electronic Device Insertion
The aim of this study is to evaluate the feasibility of the Pectoralis Nerve (PECS) block for CIED insertion.
Read the detailed description
Implantable Cardiac Electronic Device (CIED) insertion can be performed under local anesthesia, regional anesthesia, or general anesthesia. Novel regional blocks may improve pain management for such patients and can shorten their length of stay in the hospital. At the study, the investigators aimd to evaluate the efficacy and feasibility of the PECS block for CIED insertion procedure.
- Being tested
- Pectoral Nerve (PECs) block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoral Nerve (PECs) blockOther
Pectoral Nerve (PECS) blocks were performed on the side of surgery, using the ultrasound-guided technique 30 min before the implantable cardiac electronic device (pacemaker, implantable cardioverter defibrillator) insertion procedure
| Study group | Role | What they receive |
|---|---|---|
| Pectoral Nerve (PECS) block | Other | Pectoral Nerve (PECs) block was performed at the surgical side 30 min before the procedure Receives: Other: Pectoral Nerve (PECs) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of intraoperative additional local anesthetic
amount of intraoperative additional local anesthetic administered by the cardiologist during the CIED insertion procedure was recorded.
Measured: 1 hour
number of patients who requiring intraoperative additional local anesthetic
Number of patients requiring intraoperative additional local anesthetic was recorded.
Measured: 1 hour
Secondary outcomes (4)
Postoperative pain scores
Postoperative pain scores were assessed by Visual Analogue Scale (VAS) scores from 0 (no pain) to 10 (maximum possible pain) for 24 hours postoperatively.
Measured: 24 hours
time to first postoperative analgesic requirement
time to first postoperative analgesic requirement was recorded for 24 hours postoperatively
Measured: 24 hours
patient satisfaction
Patient satisfaction was assessed by a 5-point Likert scale (ie, "1: very dissatisfied," "2: dissatisfied," "3: neutral," "4: satisfied," and "5: very satisfied") 24 hours after the procedure
Measured: 24 hours
cardiologist satisfaction
Cardiologist satisfaction was assessed by a 5-point Likert scale (ie, "1: very dissatisfied," "2: dissatisfied," "3: neutral," "4: satisfied," and "5: very satisfied") 24 hours after the procedure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Jun 2021
- Primary completion6 Sep 2021
- Study completion15 Oct 2021
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 Implantable Electronic DeviceStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mustafa Kilin, M.D., Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528627
- Sponsor's protocol ID
- mustafa1
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Pectoral Nerve (PECs) Blocks in Patients Undergoing Cardiac Implantable Electronic Device Insertion
- ClinicalTrials.gov ID
- NCT05528627
- Acronym / sponsor ID
- mustafa1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 6 Sep 2022 (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.
The aim of this study is to evaluate the feasibility of the Pectoralis Nerve (PECS) block for CIED insertion.
Detailed description
Implantable Cardiac Electronic Device (CIED) insertion can be performed under local anesthesia, regional anesthesia, or general anesthesia. Novel regional blocks may improve pain management for such patients and can shorten their length of stay in the hospital. At the study, the investigators aimd to evaluate the efficacy and feasibility of the PECS block for CIED insertion procedure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pectoral Nerve (PECS) block | Other | Other: Pectoral Nerve (PECs) blockPectoral Nerve (PECs) block was performed at the surgical side 30 min before the procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anaesthesiologists grade II-IV patients
- in the age group of 18-80 years,
- Patients undergoing CIED insertion
Key exclusion criteria (6 listed)
- pre-existing infection at the block site,
- coagulopathy,
- morbid obesity (Body mass index >35 kg m-2 ),
- allergy to local anaesthetics,
- decreased pulmonary reserve,
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 |
|---|---|---|
| Pectoral Nerve (PECs) blockPectoral Nerve (PECS) blocks were performed on the side of surgery, using the ultrasound-guided technique 30 min before the implantable cardiac electronic device (pacemaker, implantable cardioverter defibrillator) insertion procedure | Other | Pectoral Nerve (PECS) block |
Primary outcome
amount of intraoperative additional local anesthetic
Time frame: 1 hour
amount of intraoperative additional local anesthetic administered by the cardiologist during the CIED insertion procedure was recorded.
number of patients who requiring intraoperative additional local anesthetic
Time frame: 1 hour
Number of patients requiring intraoperative additional local anesthetic was recorded.
4 secondary outcomes
Postoperative pain scores
Time frame: 24 hours
time to first postoperative analgesic requirement
Time frame: 24 hours
patient satisfaction
Time frame: 24 hours
cardiologist satisfaction
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Derived from this study: 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.
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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. This study is not recruiting at the moment.
Mustafa Kilin, M.D. principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pectoral Nerve (PECs) block in people with Cardiac Implantable Electronic Device and Nerve Block, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of intraoperative additional local anesthetic (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 NCT05528627, 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 6 Sep 2022.