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

NCT07581275 | Not Yet Recruiting

• 1 other identifier: B7072026000035
• Study Type: observational
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (6)

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

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

• Plasma Levobupivacaine Concentration at Each Sampling Time Point

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

• Interindividual Variability of Maximum Plasma Levobupivacaine Concentration (Cmax)

  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

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

• Time to Reach Plasma Levobupivacaine Concentration Below Prespecified Safety Threshold

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

Study Arms (1)

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.

Procedure: Ultrasound-Guided Transversus Abdominis Plane Block with Levobupivacaine

Interventions

Ultrasound-Guided Transversus Abdominis Plane Block with Levobupivacaine PROCEDURE

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.

TAP Block Pharmacokinetic Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Liege: lead

Related Publications (4)

• Jokinen MJ, Neuvonen PJ, Lindgren L, Hockerstedt K, Sjovall J, Breuer O, Askemark Y, Ahonen J, Olkkola KT. Pharmacokinetics of ropivacaine in patients with chronic end-stage liver disease. Anesthesiology. 2007 Jan;106(1):43-55. doi: 10.1097/00000542-200701000-00011.

  PMID: 17197844 BACKGROUND

• Mann B, Burch E, Shakeshaft C. Attitudes Toward Acupuncture Among Pain Fellowship Directors. Pain Med. 2016 Mar;17(3):494-500. doi: 10.1093/pm/pnv001. Epub 2015 Dec 7.

  PMID: 26814237 BACKGROUND

• Atwill ER, Harp JA, Jones T, Jardon PW, Checel S, Zylstra M. Evaluation of periparturient dairy cows and contact surfaces as a reservoir of Cryptosporidium parvum for calfhood infection. Am J Vet Res. 1998 Sep;59(9):1116-21.

  PMID: 9736387 BACKGROUND

• Yun H, Park M, Lee H, Choi EK. Healthcare Interventions for Children Using Nonimmersive Virtual Reality: A Mixed Methods Systematic Review. J Pediatr Health Care. 2024 Sep-Oct;38(5):703-716. doi: 10.1016/j.pedhc.2024.01.008. Epub 2024 Mar 10.

  PMID: 38466243 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serial venous or arterial blood samples collected during the first 180 minutes after TAP block placement. Samples will be processed to obtain plasma, which will be stored frozen for measurement of levobupivacaine concentrations using validated LC-MS/MS analysis.

MeSH Terms

Conditions

Bites and Stings

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Vincent Bonhomme, MD PhD

  Centre Hospitalier Universitaire de Liege

  STUDY DIRECTOR

Central Study Contacts

Michele Carella, MD PhD

CONTACT

+32 4 2843658; mcarella@chuliege.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share