Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- Visual Analog Scale of Pain Perception during sheath insertion
研究概览
简要总结
A randomized clinical trial to test the efficacy of EMLA cream (lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local anesthesia during transradial coronary angiography.
详细描述
A total of 444 consecutive patients, who are referred for elective coronary angiography to 1st Cardiology Department cathlab, with the suspicion of coronary artery disease (CAD) will be enrolled in this study. Exclusion criteria are acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal. Baseline clinical, demographic and procedural data of the study population were recorded.
Participants will be randomly assigned to either the EMLA (AO) or the lidocaine group (LA), by a randomization table.
Primary end-point: the perception of radial pain assessed during artery puncture and 30 minutes after sheath removal.
Secondary end-point: The number of puncture attempts, the total time required before successful sheath insertion, and the occurrence of radial artery spasm will be also documented in each group
Participants will be observed for 4 hours post angiography for development of local complications or side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •referral for elective diagnostic coronary angiography
排除标准
- •acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal.
研究组 & 干预措施
EMLA anesthetic ointment (AO)
In AO group a layer of 2.5 gr EMLA cream (standard adult dose) is applied to both wrists, 1 cm above the styloid process of the radius 30 minutes before the puncture, by an experienced cathlab nurse.
干预措施: Local anesthetic (Drug)
Local Skin Anesthetic Injection (LA)
In LA group the radial artery is infiltrated with 1-2 mL of 2% lidocaine, using a 26 G needle, 0.5-1 cm proximal to the styloid process one minute before the puncture
干预措施: local anaesthetic injection (Drug)
结局指标
主要结局
Visual Analog Scale of Pain Perception during sheath insertion
时间窗: During artery puncture
The primary end-point of the study is the perception of radial pain assessed during artery puncture
Visual Analog Scale of Pain Perception after sheath removal
时间窗: 30 minutes after sheath removal
The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal
次要结局
- Puncture efficiency (number of puncture attempts)(During radial artery catheterization)
- Radial artery spasm(During radial artery catheterization)
研究者
Dimitris Tousoulis
Professor of Cardiology
Hippocration General Hospital