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

6. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

26

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Postup: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Maximum Plasma Levobupivacaine Concentration (Cmax)
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Area Under the Plasma Concentration-Time Curve From 0 to 180 Minutes (AUC0-180) of Levobupivacaine
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Liege

Vyšetřovatelé

  • Ředitel studie: Vincent Bonhomme, MD PhD, Centre Hospitalier Universitaire de Liege

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. prosince 2026

Dokončení studie (Odhadovaný)

15. prosince 2026

Termíny zápisu do studia

První předloženo

29. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

6. května 2026

První zveřejněno (Aktuální)

12. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • B7072026000035

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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