PECs for Implantable Cardiac Electronic Device Insertion

Study Overview
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Brief Summary
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The aim of this study is to evaluate the feasibility of the Pectoralis Nerve (PECS) block for CIED insertion.

Detailed Description
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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.

Official Title
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Evaluation of the Efficacy of Pectoral Nerve (PECs) Blocks in Patients Undergoing Cardiac Implantable Electronic Device Insertion

Conditions
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Cardiac Implantable Electronic Device, Nerve Block, Anesthesia, Analgesia

Intervention / Treatment
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* Other: Pectoral Nerve (PECs) block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anaesthesiologists grade II-IV patients in the age group of 18-80 years, Patients undergoing CIED insertion Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pectoral Nerve (PECS) block<br>Pectoral Nerve (PECs) block was performed at the surgical side 30 min before the procedure | Other: Pectoral Nerve (PECs) block<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours | 
| time to first postoperative analgesic requirement | time to first postoperative analgesic requirement was recorded for 24 hours postoperatively | 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 | 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 | 24 hours |