drugset / Trial / NCT06369870

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

NCT06369870

Phase 4 Recruiting 144 enrolled Algemeen Ziekenhuis Maria Middelares
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-09-01
Primary completion
2027-11
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levobupivacaine Other / unclassified 0.25 %
Comparator Levobupivacaine Other / unclassified 30 ml

Indications

No indication recorded.