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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity of Liege

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ultrasound-Guided Transversus Abdominis Plane Block with Levobupivacaine

    Procedure/Surgery

    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.

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: TAP Block Pharmacokinetic Cohort1 intervention

Trial outcomes

Primary outcomes

1

Maximum Plasma Levobupivacaine Concentration (Cmax)

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.

Time frame
From completion of TAP block (T0) to 180 minutes post-block placement
2

Time to Maximum Plasma Levobupivacaine Concentration (Tmax)

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.

Time frame
From completion of TAP block (T0) to 180 minutes post-block placement

Secondary outcomes

1

Area Under the Plasma Concentration-Time Curve From 0 to 180 Minutes (AUC0-180) of Levobupivacaine

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.

Time frame
From completion of TAP block (T0) to 180 minutes post-block placement
2

Plasma Levobupivacaine Concentration at Each Sampling Time Point

Measured plasma concentration (µg/mL) of levobupivacaine at predefined sampling time points after TAP block.

Time frame
From completion of TAP block (T0) to 180 minutes post-block placement.
3

Interindividual Variability of Maximum Plasma Levobupivacaine Concentration (Cmax)

Interindividual variability of maximum plasma levobupivacaine concentration (Cmax), assessed using descriptive dispersion measures including standard deviation and coefficient of variation.

Time frame
From completion of TAP block (T0) to 180 minutes post-block placement
4

Association Between Area Under the Plasma Concentration-Time Curve (AUC0-180) and Clinical Factors

Association between levobupivacaine AUC0-180 (µg·min/mL) and predefined clinical factors including age, sex, body mass index (BMI), and type of surgery.

Time frame
From completion of TAP block (T0) to 180 minutes post-block placement

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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