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

2026년 5월 6일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

26

연락처 및 위치

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연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Maximum Plasma Levobupivacaine Concentration (Cmax)
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Area Under the Plasma Concentration-Time Curve From 0 to 180 Minutes (AUC0-180) of Levobupivacaine
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Liege

수사관

  • 연구 책임자: Vincent Bonhomme, MD PhD, Centre Hospitalier Universitaire de Liege

간행물 및 유용한 링크

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2026년 12월 15일

연구 등록 날짜

최초 제출

2026년 4월 29일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 6일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • B7072026000035

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아니요

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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