Changes in Plasma Local Anesthetic Concentration at Different Drug Injection Sites in Paravertebral block by proxy

Nihon University Itabashi hospital0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年7月24日

试验速览

阶段: 不适用
状态: 招募中
发起方: Nihon University Itabashi hospital
入组人数: 30
主要终点: C max

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 20age old over 至 No limit（—）

入选标准

•Adults 20 years of age or older
•Those who fall under BMI 18.5 to 25.0 kg/m2
•Patients with American Society of Anesthesiologists Pre-Anesthesia Risk Assessment (ASA-PS) 3 or less (ASA-PS Classification 1: No organic, biochemical or psychiatric abnormalities. Classification 2: Mild to moderate systematic impairment. Classification 3: Severe systematic disorder. Classification 4: Severe, life-threatening systemic disorders that cannot be cured by surgery (Classification 5: Dying). Classification 5: Dying.)
•Persons who give written consent to participate in the research.

排除标准

•Patients who do not meet the above selection criteria
•Patients allergic to amide-type local anesthetics
•Patients on anticoagulation therapy with PT-INR (Prothrombin Time International Normalized Ratio) > 1.2 or on dual anti-platelet therapy (DAPT), excluding biaaspirin monotherapy and prophylactic low molecular weight heparin therapy
•Patients with any of the contraindications listed in the package insert.
•Patients with moderate to severe hepatic dysfunction
•Patients with arrhythmia requiring pacemaker insertion
•Patients who meet all of the above selection criteria and none of the above exclusion criteria.
•Patients who have refused to participate in this study.

结局指标

主要结局

C max

时间窗: 5min, 10min, 15min, 30min, 45min, 60min, 90min and 120 min after nerve block

Determine the maximum local anaesthetic plasma concentration

Tmax

时间窗: 5min, 10min, 15min, 30min, 45min, 60min, 90min and 120 min after nerve block

The time (min) to reach the maximum plasma concentration from the value of the ropivacaine plasma concentration

次要结局

Patient pain score VAS or NRS after extubation in the operating theatre(0 h, 2 h, 6 h, before sleep, next morning after surgery, 24 h after extubation)
Record of analgesic use
Presence of PONV
Vital signs on leaving the operating theatre(on leaving the operating theatre)
Patient information and treatment from the electronic anaesthetic record
Number of cases requiring additional prescriptions for rescue analgesia
Time since awake extubation when additional analgesia was requested

研究者

发起方

Nihon University Itabashi hospital

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