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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlgemeen Ziekenhuis Maria Middelares

About this trial

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.

Eligibility criteria

Qualifiers

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%;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Levobupivacaine Hydrochloride 0.25 % Injectable Solution
  • Sodium chloride 0.9%

Treatment groups

144 Participants
are divided into 2 treatment groups