PECs for Implantable Cardiac Electronic Device Insertion
Evaluation of the Efficacy of Pectoral Nerve (PECs) Blocks in Patients Undergoing Cardiac Implantable Electronic Device Insertion
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of this study is to evaluate the feasibility of the Pectoralis Nerve (PECS) block for CIED insertion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2021
CompletedFirst Submitted
Initial submission to the registry
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
September 6, 2022
CompletedSeptember 6, 2022
August 1, 2022
3 months
August 23, 2022
September 1, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
amount of intraoperative additional local anesthetic
amount of intraoperative additional local anesthetic administered by the cardiologist during the CIED insertion procedure was recorded.
1 hour
number of patients who requiring intraoperative additional local anesthetic
Number of patients requiring intraoperative additional local anesthetic was recorded.
1 hour
Secondary Outcomes (4)
Postoperative pain scores
24 hours
time to first postoperative analgesic requirement
24 hours
patient satisfaction
24 hours
cardiologist satisfaction
24 hours
Study Arms (1)
Pectoral Nerve (PECS) block
OTHERPectoral Nerve (PECs) block was performed at the surgical side 30 min before the procedure
Interventions
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
Eligibility Criteria
You may qualify if:
- American Society of Anaesthesiologists grade II-IV patients
- in the age group of 18-80 years,
- Patients undergoing CIED insertion
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antalya Training and Research Hospital
Antalya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mustafa Kilin, M.D.
Antalya Training and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2022
First Posted
September 6, 2022
Study Start
June 1, 2021
Primary Completion
September 6, 2021
Study Completion
October 15, 2021
Last Updated
September 6, 2022
Record last verified: 2022-08