PECs for Implantable Cardiac Electronic Device Insertion

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05528627
• Other study ID #: mustafa1
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: August 2022
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 15, 2021
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Anesthesia
• Cardiac Implantable Electronic Device
• Nerve Block

Intervention

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

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	number of patients who requiring intraoperative additional local anesthetic	Number of patients requiring intraoperative additional local anesthetic was recorded.	1 hour
Secondary	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
Secondary	time to first postoperative analgesic requirement	time to first postoperative analgesic requirement was recorded for 24 hours postoperatively	24 hours
Secondary	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
Secondary	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