[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531905":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":39,"locations":49,"responsibleParty":70,"collaborators":27,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":27,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":27,"enrollmentInfo":83,"targetDuration":27,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":52,"whyStopped":27,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Jessa Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Patients in the intervention group will receive a mixture of high-dose local anesthetic and epinephrine administered via a serratus anterior plane block.",[13,14],"Procedure: High dose serratus anterior plane block (2.4 mg\u002Fkg patient ideal body weight)","Drug: PCIA with morphine",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","ACTIVE_COMPARATOR","Patients in the control group will receive a serratus anterior plane block with a low dose local anesthetic (based upon our primary trial).",[20,14],"Procedure: Low dose serratus anterior plane block (1.2mg\u002Fkg patient ideal body weight)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","High dose serratus anterior plane block (2.4 mg\u002Fkg patient ideal body weight)","The needle will be introduced in-plane from supero-anterior to postero-inferior until the needle tip is positioned in the plane underneath the serratus muscle (deep compartment). Under continuous ultrasound guidance, 3\u002F4th of the bupivacaine 0.25% plus epinephrine solution will be injected in the deep compartment. After the deep component of the serratus anterior plane block is completed, the needle will be withdrawn to the subcutaneous tissues. The needle will be flattened and advanced in-plane to the plane superficial to the serratus muscles. The remainder quarter of the bupivacaine 0.25% plus epinephrine solution will be injected superficial to the serratus muscles after correct placement of the needle tip is confirmed on ultrasound. In total a dose of 2.4mg\u002Fkg patient ideal body weight will be administered. There is a maximal dose of 200 mg adrenalized bupivacaine for patients with an ideal body weight of 83 kg or more.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Low dose serratus anterior plane block (1.2mg\u002Fkg patient ideal body weight)","The needle will be introduced in-plane from supero-anterior to postero-inferior until the needle tip is positioned in the plane underneath the serratus muscle (deep compartment). Under continuous ultrasound guidance, 3\u002F4th of the bupivacaine 0.25% will be injected in the deep compartment. After the deep component of the serratus anterior plane block is completed, the needle will be withdrawn to the subcutaneous tissues. The needle will be flattened and advanced in-plane to the plane superficial to the serratus muscles. The remainder quarter of the bupivacaine 0.25% will be injected superficial to the serratus muscles after correct placement of the needle tip is confirmed on ultrasound.",[16],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","PCIA with morphine","A patient controlled intravenous analgesia system (Bodyguard 595 Colorvision®) with morphine (Sterop®) using following settings: bolus 1.5 mg and lockout interval 7 min with maximal dose of 30mg per 4 hours.",[16,9],[38],"PCIA with Sterop",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":27,"email":44},"Björn Stessel, Dr","CONTACT","003211222107","bjorn.stessel@jessazh.be",{"name":46,"role":42,"phone":47,"phoneExt":27,"email":48},"Ina Callebout, PhD","003211339848","ina.callebaut@jessazh.be",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Jessa hospital","RECRUITING","Hasselt","Limburg","3500","Belgium","BE",{"type":59,"coordinates":60},"Point",[61,62],5.33781,50.93106,{"lat":62,"lon":61},[65,68],{"name":66,"role":42,"phone":67,"phoneExt":27,"email":44},"Björn Stessel, Dr.","003211339856",{"name":69,"role":42,"phone":47,"phoneExt":27,"email":48},"Ina Callebaut, PhD",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Stessel Björn","Principle investigator","100531905","high-versus-low-dose-serratus-anterior-plane-block-after-minimally-invasive-valve-surgery-100531905",false,"NCT06205875","High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery.","High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery: a Double-blinded Randomized Controlled Trial.","Inclusion Criteria:\n\n* Scheduled for elective aortic valve surgery or elective mitral valve surgery via right anterolateral thoracotomy\n* Adult patients (minimally 18 years old)\n* Bodyweight \\> 50kg\n* EuroScore ii \\\u003C 3%\n\nExclusion Criteria:\n\n* Refusal to participate\n* Inability to communicate due to language or neurologic barriers\n* Inability to control and self-administer opioids with PCIA or to comprehend the NRS pain score due to confusion or learning difficulties\n* Chronic use of opioids\n* Chronic use of analgesic antidepressants and\u002For antiepileptics\n* Use of prohibited medication which possibly interacts with bupivacaine-epinephrine or opioids (mexiletine, ketoconazole, theophylline, IMAO, Digitalis and cimetidine)\n* History of major trauma or surgery to right chest wall\n* History of chronic pain at right chest wall\n* Allergy to opioids and\u002For local anesthetics\n* Allergy to paracetamol\n* Class 3 obesity (BMI 40 or more)\n* Pregnancy\n* Intraoperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, brady-arrhytmias requiring external pacing,...)","ALL","18 Years",{"count":84,"type":85},100,"ESTIMATED","INTERVENTIONAL",[88],"NA","This study aims to compare the efficacy and quality of pain relief provided by the high-dose serratus anterior plane (SAP) block with the standard SAP block in preventing and treating acute postoperative pain after total endoscopic aortic or mitral valve surgery.",[91,92,93,94],"Analgesia","Surgery","Cardiac Disease","Post Operative Pain",[96,97,98,99],"Aorta\u002Fmitral valve surgery","Serratus anterior plane block","Enhanced recovery after surgery","post operative pain","2025-05-12",{"date":102,"type":103},"2025-05-14","ACTUAL",{"date":105,"type":103},"2024-02-21",{"date":107,"type":85},"2027-12-31",{"name":5,"class":6},1]