Optimization of Local Anesthetic Effect With Duplex Ultrasound Guided Injection of Lidocaine Before Femoral Artery Catheterization: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- visual analog scale (VAS) for pain evaluation
研究概览
简要总结
The aim of this study is to evaluate the optimization of local anesthetic effect with duplex ultrasound-guided injection of lidocaine before femoral artery puncture during diagnostic or therapeutic interventional procedures.
In total, 200 patients scheduled for various diagnostic or therapeutic interventional radiology procedures requiring femoral artery puncture, will be randomized in two groups after informed consent. Patients will be randomized to undergo groin local anesthesia with the proposed method of duplex ultrasound guided injection of lidocaine versus standard injection of lidocaine with manual palpation (control group).
The protocol includes the registration of patients' demographics (age, gender, risk factors for peripheral arterial disease), arterial morphological characteristics (calcifications and presence of atheromatous disease), as well as technical details of the procedure (total puncture duration, sheath size, antegrade/retrograde puncture, etc.)
Primary study endpoint will be peri-procedural pain that will be assessed with the use of a visual analog scale (VAS) completed by the patient at the end of the procedure. Secondary study endpoints will evaluate procedural safety and complications during the immediate post-procedural period (up to 7 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for diagnostic intra-arterial procedures
- •Patient scheduled for therapeutic intra-arterial procedures
- •At least 1 palpable femoral artery
- •Patient informed consent
排除标准
- •Allergic reaction to iodine contrast media
- •Allergic reaction to lidocaine
- •Bilateral obstruction of femoral arteries
- •Impaired or lost vision
研究组 & 干预措施
Manual palpation
Local anesthetic before femoral artery puncture will be injected with the classic manual palpation technique
干预措施: Injection of femoral local anesthetic (lidocaine) with manual palpation (Procedure)
Ultrasound guidance
Local anesthetic before femoral artery puncture will be performed with the use of duplex ultrasound guidance
干预措施: Ultrasound guided injection of femoral local anesthetic (lidocaine) (Procedure)
结局指标
主要结局
visual analog scale (VAS) for pain evaluation
时间窗: immediatelly after sheath placement, days 0-7
次要结局
- major and/or minor puncture site complications (infection, groin hematoma, pseudoaneurysm formation,arterio-venous fistula, major bleeding)(immediate, up to 7 days)