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Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Surgery (LEVO-TAP-PK)

6 maggio 2026 aggiornato da: Michele Carella, University of Liege

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

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/MS 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This prospective single-center pharmacokinetic observational study is designed to characterize systemic exposure to levobupivacaine after ultrasound-guided transversus abdominis plane (TAP) block performed as part of routine perioperative analgesia for elective abdominal surgery under general anesthesia.

TAP block is widely integrated into multimodal analgesic pathways because it may reduce postoperative pain and opioid requirements. However, administration of relatively large volumes of local anesthetic into fascial planes can result in measurable systemic absorption. Although levobupivacaine has a favorable safety profile compared with racemic bupivacaine, understanding peak plasma concentrations and their timing remains clinically relevant, particularly when additional analgesic strategies such as intravenous lidocaine may be considered during the perioperative period.

Eligible adult participants scheduled for abdominal surgery and already planned to receive TAP block according to institutional practice will be enrolled after informed consent. No changes to standard anesthetic or surgical management are mandated by the study. The TAP block will be performed by experienced anesthesiologists using the institutional standard technique with levobupivacaine 0.375% (total volume 40 mL; maximum dose 150 mg).

The reference time (T0) will be defined as completion of local anesthetic injection. Serial blood samples will be obtained during the early postoperative period at predefined time points up to 180 minutes after T0 to capture the expected absorption phase and early elimination profile. Plasma levobupivacaine concentrations will be quantified using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay.

The primary pharmacokinetic parameters of interest are maximum observed plasma concentration (Cmax) and time to maximum concentration (Tmax). Secondary analyses will include concentration-time profiles, area under the curve from 0 to 180 minutes (AUC0-180), interindividual variability, and exploratory evaluation of associations between exposure metrics and selected demographic or clinical variables such as age, body mass index, sex, and surgical category.

Results are expected to provide real-world pharmacokinetic data for levobupivacaine after TAP block and may help inform safer sequencing of multimodal analgesic approaches, including timing of intravenous lidocaine administration after fascial plane block. Safety monitoring will follow routine perioperative standards, and any suspected local anesthetic systemic toxicity will be managed immediately according to institutional protocols.

Tipo di studio

Osservativo

Iscrizione (Stimato)

26

Contatti e Sedi

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Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adult patients treated at CHU Liège who are scheduled for elective abdominal surgery under general anesthesia and for whom an ultrasound-guided transversus abdominis plane (TAP) block with levobupivacaine is planned as part of routine perioperative analgesic care. The study population consists of clinically stable surgical patients able to provide informed consent and undergo serial perioperative blood sampling for pharmacokinetic analysis.

Descrizione

Inclusion Criteria:

  • Age ≥18 years
  • Scheduled elective abdominal surgery under general anesthesia
  • Planned ultrasound-guided TAP block as part of standard perioperative analgesic care
  • Able to understand and speak French sufficiently to understand the study information and consent form
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Refusal or inability to provide informed consent
  • Known allergy or hypersensitivity to amide local anesthetics
  • Severe hepatic impairment
  • Renal impairment (estimated glomerular filtration rate <50 mL/min/1.73 m²)
  • Contraindication to repeated blood sampling or inability to complete the sampling schedule
  • Participation in another clinical study that could affect absorption, distribution, metabolism, or elimination of local anesthetics
  • Pregnancy
  • Emergency surgery or life-threatening urgent condition
  • Immediate postoperative instability requiring intensive care transfer (e.g., hemodynamic instability)
  • Inability to understand French sufficiently for study information and consent
  • Persons requiring special legal protection for consent (e.g., minors, guardianship, incapacity to consent)

Piano di studio

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Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
TAP Block Pharmacokinetic Cohort
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.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximum Plasma Levobupivacaine Concentration (Cmax)
Lasso di tempo: From completion of TAP block (T0) to 180 minutes post-block placement
Maximum observed plasma concentration (Cmax, µg/mL) of levobupivacaine after TAP block, determined from serial plasma samples collected during the first 180 minutes after completion of the block.
From completion of TAP block (T0) to 180 minutes post-block placement
Time to Maximum Plasma Levobupivacaine Concentration (Tmax)
Lasso di tempo: From completion of TAP block (T0) to 180 minutes post-block placement
Time to maximum observed plasma concentration (Tmax, minutes) of levobupivacaine after TAP block, determined from serial plasma samples collected during the first 180 minutes after completion of the block.
From completion of TAP block (T0) to 180 minutes post-block placement

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Area Under the Plasma Concentration-Time Curve From 0 to 180 Minutes (AUC0-180) of Levobupivacaine
Lasso di tempo: From completion of TAP block (T0) to 180 minutes post-block placement
Area under the plasma concentration-time curve (AUC0-180, µg·min/mL) of levobupivacaine following TAP block, calculated from serial plasma concentration measurements obtained during the first 180 minutes after completion of the block.
From completion of TAP block (T0) to 180 minutes post-block placement
Plasma Levobupivacaine Concentration at Each Sampling Time Point
Lasso di tempo: From completion of TAP block (T0) to 180 minutes post-block placement.
Measured plasma concentration (µg/mL) of levobupivacaine at predefined sampling time points after TAP block.
From completion of TAP block (T0) to 180 minutes post-block placement.
Interindividual Variability of Maximum Plasma Levobupivacaine Concentration (Cmax)
Lasso di tempo: From completion of TAP block (T0) to 180 minutes post-block placement
Interindividual variability of maximum plasma levobupivacaine concentration (Cmax), assessed using descriptive dispersion measures including standard deviation and coefficient of variation.
From completion of TAP block (T0) to 180 minutes post-block placement
Association Between Area Under the Plasma Concentration-Time Curve (AUC0-180) and Clinical Factors
Lasso di tempo: From completion of TAP block (T0) to 180 minutes post-block placement
Association between levobupivacaine AUC0-180 (µg·min/mL) and predefined clinical factors including age, sex, body mass index (BMI), and type of surgery.
From completion of TAP block (T0) to 180 minutes post-block placement
Time to Reach Plasma Levobupivacaine Concentration Below Prespecified Safety Threshold
Lasso di tempo: From completion of TAP block (T0) to 180 minutes post-block placement
Time required for plasma levobupivacaine concentrations to decrease below the predefined safety threshold considered compatible with initiation of intravenous lidocaine administration after TAP block.
From completion of TAP block (T0) to 180 minutes post-block placement
Interindividual Variability of Area Under the Plasma Concentration-Time Curve (AUC0-180)
Lasso di tempo: From completion of TAP block (T0) to 180 minutes post-block placement
Interindividual variability of levobupivacaine AUC0-180, assessed using descriptive dispersion measures including standard deviation and coefficient of variation.
From completion of TAP block (T0) to 180 minutes post-block placement

Collaboratori e investigatori

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Sponsor

University of Liege

Investigatori

  • Direttore dello studio: Vincent Bonhomme, MD PhD, Centre Hospitalier Universitaire de Liege

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

15 dicembre 2026

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • B7072026000035

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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