PECs for Implantable Cardiac Electronic Device Insertion

Not Applicable

Completed

• Conditions: Cardiac Implantable Electronic Device; Nerve Block; Anesthesia; Analgesia
• Interventions: Other: Pectoral Nerve (PECs) block

• Registration Number: NCT05528627
• Lead Sponsor: Antalya Training and Research Hospital

Brief Summary

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 Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-09-06
• Study Completion: 2021-10-15
• Status Verified: 2022-08
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-09-01
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pectoral Nerve (PECS) block	Pectoral Nerve (PECs) block	Pectoral Nerve (PECs) block was performed at the surgical side 30 min before the procedure

Primary Outcome Measures

Name	Time	Method
amount of intraoperative additional local anesthetic	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	1 hour	Number of patients requiring intraoperative additional local anesthetic was recorded.

Secondary Outcome Measures

Name	Time	Method
time to first postoperative analgesic requirement	24 hours	time to first postoperative analgesic requirement was recorded for 24 hours postoperatively
patient satisfaction	24 hours	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
cardiologist satisfaction	24 hours	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
Postoperative pain scores	24 hours	Postoperative pain scores were assessed by Visual Analogue Scale (VAS) scores from 0 (no pain) to 10 (maximum possible pain) for 24 hours postoperatively.

Trial Locations

Locations (1)

Antalya Training and Research Hospital; 🇹🇷 Antalya, Turkey