Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Sur… (NCT07581275) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Surgery
26 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Plasma Levobupivacaine Concentration (Cmax)
Timeframe: From completion of TAP block (T0) to 180 minutes post-block placement
2
Time to Maximum Plasma Levobupivacaine Concentration (Tmax)
Timeframe: From completion of TAP block (T0) to 180 minutes post-block placement