PECs for Implantable Cardiac Electronic Device Insertion

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Anesthesia; Nerve Block; Cardiac Implantable Electronic Device
• Intervention / Treatment: Other: Pectoral Nerve (PECs) block

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Antalya Training And Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pectoral Nerve (PECS) block; Pectoral Nerve (PECs) block was performed at the surgical side 30 min before the procedure	Other: Pectoral Nerve (PECs) block; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Principal Investigator: Mustafa Kilin, M.D., Antalya Training And Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): September 6, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: mustafa1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No