OrthoCarolina Hip & Knee Center, Charlotte, NC.
OrthoCarolina Research Institute, Charlotte, NC.
J Arthroplasty. 2018 Jan;33(1):97-101. doi: 10.1016/j.arth.2017.07.038. Epub 2017 Aug 1.
Intraoperative periarticular injections (PAIs) with local anesthetic are an important component of multimodal pain control in total joint arthroplasty. Liposomal bupivacaine is an extended-release formulation of bupivacaine designed to provide extended pain relief, approved for use in a single surgical site. The systemic safety profile for use in simultaneous bilateral TKA (bTKA) with a full dose in each knee has not been evaluated. The purpose of this study was to determine the safety and pharmacokinetics of bilateral full-dose PAI liposomal bupivacaine in the blood collected in patients undergoing simultaneous bTKA.
In this prospective study, patients had an identical PAI consisting of 20 cc of liposomal bupivacaine (266 mg), 30 cc of 0.25% bupivacaine (75 mg) with epinephrine, and 10 cc of normal saline injected into each knee during bTKA. Blood samples were collected at predefined intervals until patient discharge. No exogenous bupivacaine was administered. Pharmacokinetic evaluations were subsequently performed and compared to bupivacaine toxicity levels. Patients were monitored for adverse events related to anesthetic toxicity (cardiac and neurologic).
Fifteen patients (mean age, 60.7 years; range, 57-64 years) were enrolled in the study. The mean peak level (Cmax) was 0.8 μg/mL (range, 0.4-1.2 μg/mL). All patients were well below the reported systemic cardiac and toxicity levels reported as 2-4 μg/mL. There were no reported cardiac and neurotoxic events in any patients.
The use of full-dose PAI with liposomal bupivacaine placed into each knee during simultaneous bTKA is safe with systemic bupivacaine levels well below reported cardiac and neurotoxic levels.
关节周围注射（PAI）局部麻醉是全膝关节置换术多模式疼痛控制的重要组成部分。脂质体布比卡因是布比卡因的一种延长释放制剂，旨在提供延长的疼痛缓解，已批准用于单一手术部位。同时双侧全膝关节置换术（bTKA）中每侧膝关节均给予全剂量的脂质体布比卡因的系统安全性概况尚未得到评估。本研究的目的是确定同时进行双侧全膝关节置换术时，在收集的血液中使用双侧全剂量关节周围注射脂质体布比卡因的安全性和药代动力学。
在这项前瞻性研究中，患者在双侧全膝关节置换术期间，每侧膝关节接受相同的 PAI，包括 20 cc 的脂质体布比卡因（266 mg）、30 cc 的 0.25%布比卡因（75 mg）加肾上腺素和 10 cc 的生理盐水。在预定的时间间隔采集血样，直到患者出院。未给予外源性布比卡因。随后进行药代动力学评估，并与布比卡因毒性水平进行比较。监测患者与麻醉毒性相关的不良事件（心脏和神经）。
本研究纳入了 15 名患者（平均年龄 60.7 岁；范围，57-64 岁）。平均峰值水平（Cmax）为 0.8 μg/mL（范围，0.4-1.2 μg/mL）。所有患者的系统心脏毒性和毒性水平均远低于报告的 2-4 μg/mL。在任何患者中均未报告心脏和神经毒性事件。
在同时进行双侧全膝关节置换术时，每侧膝关节均给予全剂量关节周围注射脂质体布比卡因是安全的，系统布比卡因水平远低于报告的心脏和神经毒性水平。
