[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639984":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":10,"responsibleParty":31,"collaborators":10,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":37,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":10,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":10},{"fullName":5,"class":6},"University of Liege","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TAP Block Pharmacokinetic Cohort",null,"Adult participants undergoing elective abdominal surgery under general anesthesia at CHU Liège who receive an ultrasound-guided transversus abdominis plane (TAP) block with levobupivacaine 0.375% (total volume 40 mL; maximum dose 150 mg) as part of standard perioperative analgesic management. This is a single observational cohort. The intervention of interest is the routine TAP block, after which serial blood samples are collected up to 180 minutes to characterize plasma levobupivacaine pharmacokinetics. No experimental treatment is assigned by the study.",[13],"Procedure: Ultrasound-Guided Transversus Abdominis Plane Block with Levobupivacaine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Ultrasound-Guided Transversus Abdominis Plane Block with Levobupivacaine","Ultrasound-guided transversus abdominis plane (TAP) block performed as part of routine perioperative analgesia after induction of general anesthesia for elective abdominal surgery. Levobupivacaine 0.375% is injected into the transversus abdominis fascial plane under real-time ultrasound visualization, using a total volume of 40 mL (typically bilateral administration, adjusted to surgical indication), with a maximum total dose of 150 mg. The block is performed by an experienced anesthesiologist according to institutional standard practice.",[9],[21],{"name":22,"affiliation":23,"role":24},"Vincent Bonhomme, MD PhD","Centre Hospitalier Universitaire de Liege","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Michele Carella, MD PhD","CONTACT","+32 4 2843658","mcarella@chuliege.be",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Michele Carella","Clinical Professor","100639984","plasma-kinetics-of-levobupivacaine-after-transversus-abdominis-plane-tap-block-in-abdominal-surgery-100639984",false,"NCT07581275","Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Surgery","Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Surgery: A Prospective Study and Definition of a Safety Window for Intravenous Lidocaine Administration","LEVO-TAP-PK","Inclusion Criteria:\n\n* Age ≥18 years\n* Scheduled elective abdominal surgery under general anesthesia\n* Planned ultrasound-guided TAP block as part of standard perioperative analgesic care\n* Able to understand and speak French sufficiently to understand the study information and consent form\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent\n* Known allergy or hypersensitivity to amide local anesthetics\n* Severe hepatic impairment\n* Renal impairment (estimated glomerular filtration rate \\\u003C50 mL\u002Fmin\u002F1.73 m²)\n* Contraindication to repeated blood sampling or inability to complete the sampling schedule\n* Participation in another clinical study that could affect absorption, distribution, metabolism, or elimination of local anesthetics\n* Pregnancy\n* Emergency surgery or life-threatening urgent condition\n* Immediate postoperative instability requiring intensive care transfer (e.g., hemodynamic instability)\n* Inability to understand French sufficiently for study information and consent\n* Persons requiring special legal protection for consent (e.g., minors, guardianship, incapacity to consent)","ALL","18 Years","75 Years",{"count":47,"type":48},26,"ESTIMATED","OBSERVATIONAL","This prospective single-center observational pharmacokinetic study will evaluate plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane (TAP) block in adult patients undergoing elective abdominal surgery under general anesthesia at CHU Liège. Participants receiving TAP block as part of standard clinical care (levobupivacaine 0.375%, total volume 40 mL, maximum dose 150 mg) will undergo serial blood sampling at 3, 7, 15, 30, 60, 120, and 180 minutes after block completion. Plasma levobupivacaine concentrations will be measured using validated LC-MS\u002FMS methods. The primary objectives are to estimate maximum plasma concentration (Cmax) and time to maximum concentration (Tmax). Secondary objectives include characterization of the concentration-time profile, AUC0-180, interindividual variability, and exploratory associations with clinical factors (age, sex, BMI, type of surgery). The study also aims to inform a pragmatic safety window for subsequent intravenous lidocaine infusion used in multimodal analgesia protocols. Approximately 26 participants will be enrolled. No modification of routine anesthesia or analgesic care is required apart from study-related blood sampling.",[52,53,54,55,56],"Abdominal Surgery Patients","Transversus Abdominis Plane (TAP) Block","Pharmacokinetic Analysis","Levobupivacaine","Local Anaesthetic Systemic Toxicity","NOT_YET_RECRUITING","2026-05-06",{"date":60,"type":61},"2026-05-12","ACTUAL",{"date":63,"type":48},"2026-07-01",{"date":65,"type":48},"2026-12-15",{"name":5,"class":6}]