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Study on the Effects of Ropivacaine and Lidocaine in Patients Receiving Cardiac Device Implants

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who need a subpectoral implantation of cardiac implantable electronic devices (CIEDs). The study aims to compare two types of anesthesia used during the procedure: local anesthesia and regional anesthesia known as the PECS II block. The main goal is to assess how these anesthesia methods affect the patient's comfort and recovery, using a tool called the Quality of Recovery 15 Score (QoR-15), which measures the quality of recovery after surgery.

In this study, two medications are being used. The first is Ropivacaine hydrochloride, which is a regional anesthetic provided as a solution for infusion. The second is Lidocaine hydrochloride, a local anesthetic given as a solution for injection. These medications help numb the area where the device is implanted, reducing pain during and after the procedure. Some patients will receive a placebo instead of one of these medications to compare the effects.

Participants in the trial will be randomly assigned to one of two groups, each receiving a different type of anesthesia. The study will monitor the patients' recovery and comfort levels for 24 hours after the procedure, using the QoR-15 score. Additional factors such as the need for extra pain relief, the stability of vital signs, and the length of hospital stay will also be observed. The trial is designed to provide valuable insights into which anesthesia method offers better comfort and recovery for patients undergoing CIED implantation.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be at least 18 years old and able to provide informed consent. Female participants of childbearing potential must have a negative pregnancy test before starting the trial.

  2. Step 2

    Preparation for procedure

    Participants are prepared for the subpectoral implantation of cardiac implantable electronic devices (CIEDs). This involves a medical assessment to ensure readiness for the procedure.

  3. Step 3

    Anaesthesia administration

    Participants receive either local anaesthesia or a PECS II block (a type of regional anaesthesia) before the procedure. The choice of anaesthesia is determined by the study protocol.

  4. Step 4

    Procedure

    The subpectoral implantation of the CIED is performed. During the procedure, additional local anaesthetic may be administered if necessary.

  5. Step 5

    Postoperative care

    After the procedure, participants are monitored for recovery. The Quality of Recovery 15 Score (QoR-15) is assessed 24 hours post-procedure to evaluate comfort and recovery quality.

    Pain levels are measured using a visual analogue scale (VAS) at 2, 4, 6, 12, and 24 hours after the procedure. Additional pain relief may be provided based on these assessments.

  6. Step 6

    Follow-up assessments

    Participants undergo further assessments to monitor recovery and any changes in health status. This includes evaluating hemodynamic stability, anaesthesia duration, and any necessary intensive care unit (ICU) stay.

    The study also tracks changes in specific health markers and overall hospital stay duration.

Who can join the trial?

4 criteria

  • Patients must be **18 years or older** at the time they agree to participate.
  • Patients must be able to **understand** and be willing to **sign and date** a written consent form, which is a document that shows they agree to take part in the study.
  • Female participants who can have children may join the study if they meet these conditions:
    • They have a **negative pregnancy test** with high sensitivity at the start of the study and on the day they receive the first dose.
    • They are **not currently breastfeeding**.

Who cannot join the trial?

3 criteria

  • Patients who do not need a **subpectoral implantation** of **cardiac implantable electronic devices (CIEDs)**. This means if you don't need a device placed under the chest muscle to help your heart, you cannot join.
  • Patients who are not in the specified age range. The study is for certain age groups, so if you are not in these groups, you cannot participate.
  • Patients who are part of a vulnerable population. This means if you are in a group that needs special protection, you cannot join the study.
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Investigated drugs

  • Local Anaesthesia

    is a type of medication used to numb a specific area of the body. In this trial, it is used to reduce pain and discomfort during the implantation of cardiac devices by blocking the sensation in the area where the procedure is performed.

  • PECS II Block

    is a regional anaesthesia technique that involves injecting anaesthetic near the chest muscles to block pain in a larger area than local anaesthesia. This method is used in the trial to assess its effectiveness in improving patient comfort and recovery quality during and after the implantation of cardiac devices.

What is already known about the treatment

  • Local Anesthesia

    This medication is administered through injection at the site where a cardiac implantable electronic device (CIED) is to be placed. It is commonly used in medical procedures to numb a specific area of the body, allowing for pain-free surgery or treatment. Local anesthesia is well-established in medical literature and is widely used for minor surgical procedures. It works by blocking nerve signals in the area where it is applied, preventing pain sensations from reaching the brain. It is classified as a local anesthetic and is often used for its effectiveness in providing targeted pain relief without affecting the patient's overall consciousness.

  • Regional Anesthesia (PECS II Block)

    This form of anesthesia is administered through an injection near the nerves that supply the chest area, specifically for procedures involving the implantation of cardiac devices. It is a newer technique in medical practice, gaining attention for its effectiveness in providing pain relief for surgeries involving the chest. The PECS II block works by blocking nerve signals in a larger region of the body compared to local anesthesia, offering more extensive pain control. It is classified under regional anesthetics and is particularly noted for improving patient comfort and recovery quality in specific surgical procedures.

Investigated diseases

Need for a subpectoral implantation of cardiac implantable electronic devices (CIEDs) – This condition involves the requirement for placing electronic devices under the chest muscle to help manage heart rhythm disorders. These devices, such as pacemakers or defibrillators, are used to correct irregular heartbeats or prevent sudden cardiac arrest. The implantation process involves creating a pocket under the pectoral muscle where the device is placed, with leads connected to the heart. Over time, the device monitors heart activity and delivers electrical impulses when necessary to maintain a normal heart rhythm. The procedure is typically performed under local or regional anesthesia, and patients may experience varying levels of comfort and recovery post-surgery. The focus is on ensuring the device functions correctly and monitoring the patient's recovery and adaptation to the device.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508997-27-00Protocol codePECS-CIEDEstimated enrolment80 patientsSponsorMedizinische Universitaet Innsbruck

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