Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Surgery (LEVO-TAP-PK)
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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Michele Carella, MD PhD
- 電話番号：+32 4 2843658
- メール：mcarella@chuliege.be
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maximum Plasma Levobupivacaine Concentration (Cmax)
時間枠：From completion of TAP block (T0) to 180 minutes post-block placement
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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.
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From completion of TAP block (T0) to 180 minutes post-block placement
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Time to Maximum Plasma Levobupivacaine Concentration (Tmax)
時間枠：From completion of TAP block (T0) to 180 minutes post-block placement
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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.
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From completion of TAP block (T0) to 180 minutes post-block placement
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Area Under the Plasma Concentration-Time Curve From 0 to 180 Minutes (AUC0-180) of Levobupivacaine
時間枠：From completion of TAP block (T0) to 180 minutes post-block placement
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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.
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From completion of TAP block (T0) to 180 minutes post-block placement
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Plasma Levobupivacaine Concentration at Each Sampling Time Point
時間枠：From completion of TAP block (T0) to 180 minutes post-block placement.
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Measured plasma concentration (µg/mL) of levobupivacaine at predefined sampling time points after TAP block.
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From completion of TAP block (T0) to 180 minutes post-block placement.
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Interindividual Variability of Maximum Plasma Levobupivacaine Concentration (Cmax)
時間枠：From completion of TAP block (T0) to 180 minutes post-block placement
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Interindividual variability of maximum plasma levobupivacaine concentration (Cmax), assessed using descriptive dispersion measures including standard deviation and coefficient of variation.
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From completion of TAP block (T0) to 180 minutes post-block placement
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Association Between Area Under the Plasma Concentration-Time Curve (AUC0-180) and Clinical Factors
時間枠：From completion of TAP block (T0) to 180 minutes post-block placement
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Association between levobupivacaine AUC0-180 (µg·min/mL) and predefined clinical factors including age, sex, body mass index (BMI), and type of surgery.
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From completion of TAP block (T0) to 180 minutes post-block placement
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Time to Reach Plasma Levobupivacaine Concentration Below Prespecified Safety Threshold
時間枠：From completion of TAP block (T0) to 180 minutes post-block placement
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Time required for plasma levobupivacaine concentrations to decrease below the predefined safety threshold considered compatible with initiation of intravenous lidocaine administration after TAP block.
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From completion of TAP block (T0) to 180 minutes post-block placement
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Interindividual Variability of Area Under the Plasma Concentration-Time Curve (AUC0-180)
時間枠：From completion of TAP block (T0) to 180 minutes post-block placement
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Interindividual variability of levobupivacaine AUC0-180, assessed using descriptive dispersion measures including standard deviation and coefficient of variation.
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From completion of TAP block (T0) to 180 minutes post-block placement
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Vincent Bonhomme, MD PhD、Centre Hospitalier Universitaire de Liege
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
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研究記録日
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研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
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最終確認日
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