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Study on High vs. Low Dose Bupivacaine Hydrochloride and Epinephrine for Pain Relief After Aortic Valve Replacement Surgery

Verified siteRegistered drugNo placebo
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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 undergoing minimally invasive heart valve surgery, specifically those having an aortic valve replacement. The study is investigating the effectiveness of a pain management technique called the serratus anterior plane block, which is a type of local anesthesia. The treatment being tested involves two different doses of a medication called Marcaine, which contains the active substances bupivacaine hydrochloride and epinephrine. These substances are used to numb the area and reduce pain after surgery.

The purpose of the study is to see if using a higher dose of this local anesthesia can reduce the need for additional pain medication, such as opioids, after surgery. Participants in the study will be randomly assigned to receive either a high dose or a low dose of the anesthesia. The study will monitor how much additional pain medication is needed, as well as the level of pain experienced by patients, their satisfaction with pain management, and their recovery process, including how quickly they can move around after surgery.

Throughout the study, various aspects of recovery will be assessed, such as the time it takes for patients to be ready to leave the intensive care unit, their overall satisfaction with pain relief, and their quality of life after surgery. The study aims to provide valuable information on how to improve pain management for patients undergoing heart valve surgery, potentially leading to better recovery experiences and outcomes.

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

    Participation begins after being scheduled for elective aortic or mitral valve surgery through a right anterolateral thoracotomy.

    Eligibility requires being at least 18 years old and having a EuroScore ii of less than 3%.

  2. Step 2

    Administration of anesthesia

    A serratus anterior plane block is performed using a solution containing bupivacaine hydrochloride and epinephrine.

    This solution is administered as an injectable solution to manage pain after surgery.

  3. Step 3

    Monitoring and evaluation

    Pain relief effectiveness is assessed using a numeric scale from 0 (no pain) to 10 (worst pain) at various intervals: 4, 8, 12, and 24 hours after the block, and again on the seventh day after surgery.

    Opioid consumption is monitored at intervals of 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24 hours after the block.

  4. Step 4

    Postoperative care

    Patient satisfaction with pain management is evaluated 24 hours after the block using a satisfaction scale from 0 (not satisfied) to 10 (extremely satisfied).

    The time from arrival in the intensive care unit (ICU) to extubation and first mobilization is recorded.

  5. Step 5

    Additional assessments

    The impact of nausea and vomiting is assessed 24 hours after the block using a specific scale.

    The time to first bowel movement or need for laxatives is monitored during the hospital stay.

  6. Step 6

    Discharge and recovery

    The time from ICU arrival to meeting discharge criteria to the ward is recorded.

    The overall recovery quality is assessed on the second and seventh days after surgery using quality of life questionnaires.

Who can join the trial?

3 criteria

  • Must be scheduled for planned (elective) aortic valve surgery or planned mitral valve surgery through a right anterolateral thoracotomy, which is a type of surgical approach to the chest.
  • Must be an adult, at least 18 years old.
  • Must have a **EuroScore ii** of less than 3%. **EuroScore ii** is a system used to predict the risk of death after heart surgery.

Who cannot join the trial?

4 criteria

  • Patients who are not undergoing an aortic valve replacement surgery.
  • Patients who are not receiving a serratus anterior plane block, which is a type of pain relief technique used during surgery.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

Serratus Anterior Plane Block is a type of regional anesthesia used to numb the chest area. In this trial, it is being tested in two different doses to see if a higher dose can reduce the need for opioid pain medications after minimally invasive heart valve surgery. The goal is to find out if using a higher dose of this local anesthetic can help patients experience less pain and therefore use fewer opioids for pain relief.

What is already known about the treatment

Local Anesthesia – This medication is administered through an injection, specifically as a serratus anterior plane block, which is a type of regional anesthesia. It is currently being studied in clinical trials to assess its effectiveness in reducing opioid consumption after minimally invasive aortic valve replacement surgery. The main therapeutic indication is pain management following surgical procedures. At the molecular level, local anesthesia works by blocking nerve signals in the body, preventing pain sensations from reaching the brain. It is classified pharmacologically as a local anesthetic.

Investigated diseases

Aortic Valve Replacement – Aortic valve replacement is a surgical procedure used to treat conditions affecting the aortic valve, such as aortic stenosis or aortic regurgitation. During the procedure, the damaged valve is removed and replaced with a mechanical or biological valve. This surgery helps restore normal blood flow, reducing symptoms like chest pain, shortness of breath, and fatigue. Recovery involves monitoring for complications and gradual return to normal activities. The procedure is typically performed under general anesthesia and requires a hospital stay. Postoperative care focuses on pain management and monitoring heart function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508719-22-00Estimated enrolment100 patientsSponsorJessa Ziekenhuis

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