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

NCT07581275 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Abdominal Surgery Patients
  • Transversus Abdominis Plane (TAP) Block
  • Pharmacokinetic Analysis
  • Levobupivacaine
  • Local Anaesthetic Systemic Toxicity

Interventions

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.

Sponsors & Collaborators

  • University of Liege

    lead OTHER

Principal Investigators

  • Vincent Bonhomme, MD PhD · Centre Hospitalier Universitaire de Liege

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-01
Completion
2026-12-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07581275 on ClinicalTrials.gov