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临床试验/NCT04239053
NCT04239053已完成不适用

Measurement of Bupivacaine Level Following ESPB (Erector Spinae Plane Block ) as a Part of Multimodal Analgesia

Maltepe University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年3月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Bupivacaine plasma concentration

研究概览

简要总结

Erector Spinae Plane Block (ESPB) is a regional anesthesia technique that is used for as a part of multimodal analgesia. Bupivacaine is one of the local anesthetic drugs and it is applied for ESPB. In this study, it is aimed to examine its blood concentration following the application for ESPB regarding its adverse effects and pharmacokinetics.

详细描述

ESPB is prefered block technique for thoraco abdominal surgeries. Bupivacaine is a widely used drug for these kind blocks.The systemic absorption rate of bupivacaine depends on the dose administered, the route of administration, and the vascularization of the injection site. The highest plasma concentration is achieved in intercostal blocks due to its rapid absorption (4 mg / liter after 400 mg dose).

The lowest plasma concentrations are seen in subcutaneous administration in the abdominal region. Total plasma clearance of bupivacaine was 0.58 L / min, steady state distribution volume was 73 liters, the elimination half-life was 2.7 hours and the hepatic extraction rate was 0.40. The maximum applicable legal dose varies by country. While it is 150 mg in Sweden, it is administered up to 400 mg in 24 hours in Finland. Clearance of bupivacaine has been shown to be lower in uremic patients. Plasma concentrations of highly proteing binding drugs are significantly effected by low cardiac output. The pharmacokinetics of many local anesthetics are influenced by inadequate liver function due to changes in body fluids and circulation. However, it seems safe in single dose blocks in patients with hepatic dysfunction. CYP2D6 enzyme inhibitors such as propranolol and CYP3A4 inhibitors such as itraconazole can reduce the clearance of bupivacaine by up to 30%.

As the concentration of local anesthetics including bupivacaine increases in systemic circulation, signs and symptoms of cardiovascular central nervous systems appear. The doses of bupivacaine that produce cardiovascular toxicity / central nervous system toxicity are similar. Stopping the administration of local anesthetics when early signs of the central nervous system observed does not prevent cardiotoxicity. Therefore, measurement of plasma levels of the drug may be important.

The blood level of bupivacaine is not routinely measured. Bupivacaine When the arterial plasma concentration is above 1.5 /g / ml, dizziness may occur, peripheral paresthesia above 2.0 /g / ml, and convulsions above 4.0 /g / ml. Intramuscular administration of 1.3 ug/kg causes psychomotor impairment in motor vehicle use. Dose-dependent central nervous system adverse effects are monitored and patient-related adverse event information is recorded. In a study in which toxic effects were observed with bupivacaine, which included 11,080 patients, the number of systemic toxicities was found to be 15 and none of them had permanent sequelae.

There are no reports on plasma bupivacaine levels in patients undergoing ESPB.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

ESPB block group

Patients receiving ESPB will be enrolled to this group.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Bupivacaine plasma concentration

时间窗: 10 sampling in 720 minutes after application.

Determining plasma bupivacaine level after injection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Onur Selvi

Associate professor

Maltepe University

研究点 (1)

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