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Completed

NCT Number: NCT05528627

PECs for Implantable Cardiac Electronic Device Insertion

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

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Key information

Conditions

Cardiac Implantable Electronic Device Agnosia Analgesia Anesthesia Nerve Block Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pectoral Nerve (PECs) block

Other

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

Primary outcomes

  1. amount of intraoperative additional local anesthetic

    Time frame: 1 hour

    amount of intraoperative additional local anesthetic administered by the cardiologist during the CIED insertion procedure was recorded.

  2. number of patients who requiring intraoperative additional local anesthetic

    Time frame: 1 hour

    Number of patients requiring intraoperative additional local anesthetic was recorded.

Secondary outcomes

  1. Postoperative pain scores

    Time frame: 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.

  2. time to first postoperative analgesic requirement

    Time frame: 24 hours

    time to first postoperative analgesic requirement was recorded for 24 hours postoperatively

  3. patient satisfaction

    Time frame: 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

  4. cardiologist satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2022
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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