在接受结直肠癌手术的成人中，将罗哌卡因腹横肌平面阻滞与静脉输注利多卡因联合应用：一项开放标签、剂量递增的探索性试验。
Combining ropivacaine transversus abdominis plane block with intravenous lidocaine infusion in adults undergoing colorectal cancer surgery: an open-label, dose-escalation exploratory trial.
作者信息
Zhou Mengmeng, Yu Feng, Xu Yan, Wu Jingwen, Luowu Lajing, Tang Qianqian, Hao Xiaoting, Shao Kun, Ye Mao, Bo Lulong, Zhou Li, Jiang Chunling
机构信息
Department of Anaesthesiology, West China Hospital, The Research Units of West China (2018RU012), Sichuan University, Chinese Academy of Medical Sciences, Chengdu, China.
Department of Neurology, West China Hospital, Sichuan University, Chengdu, China.
出版信息
BMC Anesthesiol. 2025 Jul 22;25(1):357. doi: 10.1186/s12871-025-03225-5.
BACKGROUND
The concurrent use of a ropivacaine transversus abdominis plane (TAP) block with intravenous lidocaine infusion, though effective for pain relief, raises safety concerns regarding local anesthetic systemic toxicity (LAST). This study aimed to assess the dose-risk relationship of LAST in this combination by escalating the ropivacaine dose while fixing the lidocaine dose.
METHODS
In this dose-escalation study, adult patients undergoing colorectal cancer surgery received a 0.2% ropivacaine TAP block (1.5, 2.0 or 2.5 mg kg) and intravenous lidocaine infusion (2 mg kg bolus, followed by 2 mg kg h), both dosed according to ideal body weight (IBW). The primary outcome was the occurrence of LAST, identified by clinical symptoms, new-onset ECG irregularities, etc. Secondary outcomes included plasma concentrations of ropivacaine and lidocaine.
RESULTS
Nine patients were included in the per-protocol analysis, and 26 were included in the intention-to-treat analysis. No signs of LAST were observed. Plasma ropivacaine concentrations remained consistently below 2.2 µg mL, however, eight patients in the intention-to-treat population and three patients in the per-protocol population had plasma lidocaine concentrations exceeding 5.0 µg mL at 10 min post-bolus. In the per-protocol population, peak plasma ropivacaine concentrations occurred at 30 min (range, 20-60) post-TAP block, with median values of 1.14 (range, 0.85-1.18), 1.42 (range, 1.29-1.80), and 1.96 (range, 1.47-2.06) µg mL across dose groups. The peak plasma lidocaine concentrations in patients occurred at 10 min post-bolus infusion, with median values of 4.59 µg mL (range, 3.24-6.67) and gradually decreased after 2 h. The intention-to-treat analysis found similar results.
CONCLUSION
Although no signs of LAST were observed with the combination of a 1.5 to 2.5 mg kg ropivacaine TAP block and intravenous lidocaine infusion under general anaesthesia, extreme caution is still warranted regarding the potential risk of LAST.
TRIAL REGISTRATION
This trial was registered at ClinicalTrials.gov (NCT06006026) on 23 August 2023.
背景
罗哌卡因腹横肌平面（TAP）阻滞与静脉输注利多卡因联合使用，虽然对缓解疼痛有效，但引发了关于局部麻醉药全身毒性（LAST）的安全担忧。本研究旨在通过固定利多卡因剂量并逐步增加罗哌卡因剂量，评估这种联合用药中LAST的剂量-风险关系。
方法
在这项剂量递增研究中，接受结直肠癌手术的成年患者接受了0.2%罗哌卡因TAP阻滞（1.5、2.0或2.5mg/kg）和静脉输注利多卡因（2mg/kg推注，随后2mg/kg/h），两者均根据理想体重（IBW）给药。主要结局是LAST的发生，通过临床症状、新发心电图异常等确定。次要结局包括罗哌卡因和利多卡因的血浆浓度。
结果
符合方案分析纳入9例患者，意向性分析纳入26例患者。未观察到LAST的迹象。罗哌卡因血浆浓度始终保持在2.2μg/mL以下，然而，意向性分析人群中的8例患者和符合方案人群中的3例患者在推注后10分钟时血浆利多卡因浓度超过5.0μg/mL。在符合方案人群中，TAP阻滞后30分钟（范围20 - 60分钟）出现罗哌卡因血浆浓度峰值，各剂量组中位数分别为1.14（范围0.85 - 1.18）、1.42（范围1.29 - 1.80）和1.96（范围1.47 - 2.06）μg/mL。患者利多卡因血浆浓度峰值出现在推注后10分钟，中位数为4.59μg/mL（范围3.24 - 6.67），2小时后逐渐下降。意向性分析得出类似结果。
结论
虽然在全身麻醉下，1.5至2.5mg/kg罗哌卡因TAP阻滞与静脉输注利多卡因联合使用未观察到LAST的迹象，但对于LAST的潜在风险仍需极度谨慎。
试验注册
本试验于2023年8月23日在ClinicalTrials.gov（NCT06006026）注册。
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