Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06369870

Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy

Led by Algemeen Ziekenhuis Maria Middelares · Updated on 2024-09-19

144

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia, specifically the interpectoral pectoserratus plane (IPP-PSP) block, in comparison to a placebo (sham block) after Aortic Valve Replacement via Right Anterior Minithoracotomy (AVR-RAT). The main question the trial aims to answer is: Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery? The purpose is to understand the impact of the IPP-PSP block on postoperative pain. Therefore, the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients' first 48 hours after surgery. Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, including differences in pain scores, incidence of nausea and vomiting, quality of recovery, quality of life, and the length of hospital stay between the two groups. Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery.

CONDITIONS

Official Title

Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (18 years of age or older)
  • Patients scheduled for minimally invasive aortic valve replacement via right anterior minithoracotomy
  • Patients with American Society of Anesthesiologists (ASA) physical status classification II, III or IV
  • Patients with European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 4%
  • Patient has given written, free and informed consent
Not Eligible

You will not qualify if you...

  • BMI > 35
  • Patients under legal protection (curatorship, guardianship)
  • Patients subject to a legal protection measure
  • An adult who is incapable or unable to give consent
  • Patients requiring emergency surgery within 24 hours
  • Chronic opioid use (> 3 administrations per week or continuous transdermal therapy, longer than the last 3 months)
  • Patients known with chronic pain
  • Patients known with an allergy to levobupivacaine or drugs used as standard of care, including amongst others piritramide, dexamethasone, propofol, remifentanil, rocuronium, acetaminophen, ondansetron
  • Patients who receive medication that could possibly interact with levobupivacaine (mexiletine, ketoconazole, theophylline)
  • Patients who took monoamine oxidase (MAO) inhibitors within the last 2 weeks before surgery
  • Patients with chronic renal failure (dialysis dependent, estimated glomerular filtration rate (eGFR) < 30 ml.min-1.(1,73 m�b2)-1)
  • Patients with severe hepatic impairment (Model for End-Stage Liver Disease (MELD) score 4 20)
  • Patients with preoperative cognitive dysfunction (Mini Mental State Examination (MMSE) score < 24)
  • Patients with uncontrolled epilepsy
  • Patients with severe arterial hypotension (Systolic Arterial Pressure (SAP) < 90 mmHg, cardiogenic shock)
  • Patients who simultaneously participate in another interventional clinical trial
  • Soft tissue infection in the area of the procedure
  • Patients who are pregnant, parturient or breast-feeding women
  • Patients who are unable to sufficiently speak and write in the Dutch language

AI-Screening

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Trial Site Locations

Total: 1 location

1

AZ Maria Middelares

Ghent, East-Flanders, Belgium, 9000

Actively Recruiting

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Research Team

B

Bart Vaes, MD

CONTACT

E

Ella Hermie, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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