protocolSection identificationModule nctId: NCT06369870, orgStudyIdInfo id: PAINCARE, briefTitle: Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy, acronym: PAINCARE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-11, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Algemeen Ziekenhuis Maria Middelares, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Analgesic Effect, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The trial is designed as a single-center, prospective, double-blind, randomized controlled superiority trial. Patients will be randomly assigned to either the IPP-PSP block group or the sham block group (placebo)., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Neither the participant, anesthesiologist, study nurse, surgeon, nor the doctors and nurses in the Intensive Care Unit will know the participant's group assignment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Levobupivacaine Hydrochloride 0.25 % Injectable Solution, interventions name: Sodium chloride 0.9%, outcomesModule primaryOutcomes measure: Cumulative opioid consumption, secondaryOutcomes measure: Number of episodes of postoperative pain, secondaryOutcomes measure: Time to need for rescue medication, secondaryOutcomes measure: Number of patients with respiratory complications, secondaryOutcomes measure: PaCO2 levels, secondaryOutcomes measure: Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire, secondaryOutcomes measure: Number of episodes of postoperative nausea and vomiting, secondaryOutcomes measure: Time to extubation, secondaryOutcomes measure: Number of hours spent in the Intensive Care Unit, secondaryOutcomes measure: Hospitalization duration, secondaryOutcomes measure: Quality of life measured by the 5 level version of the EuroQoL-5 Dimension questionnaire, secondaryOutcomes measure: Days alive and at home, secondaryOutcomes measure: Vital status (whether the patient is alive or dead), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bart Vaes, city: Gent, state: Oost-Vlaanderen, zip: 9000, country: Belgium, contacts name: Bart Vaes, MD, role: CONTACT, phone: +3292461700, email: bart.vaes@mijnziekenhuis.be, contacts name: Steffi Ryckaert, MSc, role: CONTACT, phone: +3292461910, email: steffi.ryckaert@mijnziekenhuis.be, geoPoint lat: 51.05, lon: 3.71667, hasResults: False