Clinical Trial

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

Study acronym: PAINCARE
Recruiting Phase 4
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-04-12.
Status change: Not Yet Recruiting → Recruiting 2024-09-05
Trial Details
NCT Number NCT06369870
Lead Sponsor Algemeen Ziekenhuis Maria Middelares
Conditions Analgesic Effect
Enrollment 144 participants
Start Date 2024-09-01
Primary Completion 2027-11 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2024-09-19