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临床试验/jRCT1031240232
jRCT1031240232招募中不适用

Analgesic effect of intraosseous catheter placement in the anterior scalene muscle during brachial plexus block

Nihon University Itabashi hospital0 个研究点目标入组 30 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
主要终点
Pain score (VAS scale)

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

Pain score (VAS scale)

时间窗: 0, 2, 6, 12 (before sleep and after waking), 24, and 24 hours after surgery

Visual Analogue Scale

Pain score (NRS)

时间窗: 0, 2, 6, 12 (before sleep and after waking), 24, and 24 hours after surgery

Numerical rating scale

次要结局

  • Number of cases requiring additional rescue analgesia
  • Presence of PONV
  • Vital signs upon leaving the operating room
  • Degree of muscle weakness
  • Time to rehabilitation ambulation
  • Number of days in hospital
  • Presence or absence of postoperative delirium
  • Presence or absence of sleep disturbance

研究者

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