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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05528627
Other study ID # mustafa1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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