Radial Artery Blood Gas Sampling: A Randomised Controlled Trial of Lidocaine Local Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
Arterial Blood Gas (ABG) sampling is a common procedure in all hospitals worldwide. Often, ABG samples are obtain from inserting a needle into the radial artery at the wrist - this procedure is often painful and dreaded by patients. Therefore, some doctors use local anaesthetic but others argue that it makes the procedure more difficult and causes pain itself. The use of local anaesthetic costs approximately £1 per injection and when thousands of ABGs are performed per month, the cost is easily appreciable. However, there is no good research to guide clinicians in the use or omission of local anaesthetic for ABGs. This is the first randomised clinical trial to assess the efficacy of injected local anaesthetic on the perceived pain of radial artery puncture.
详细描述
Introduction Arterial Blood Gas (ABG) sampling is a common procedure in clinical practice, in order to obtain arterial blood for monitoring of respiratory/metabolic disease.
Normally, ABG sampling involves puncturing the radial artery with a needle and syringe. which is associated with significant pain.
Local anaesthetic agents (LA) may be infiltrated into the skin overlying the radial artery in order to reduce pain and vasospasm. LA may be in the form of topical creams or solutions for subcutaneous injection (eg. lignocaine). Similarly, LA formulations have varying concentrations of the active agent, incrementally ranging from 0.5% to 4%.
An early 3-group placebo controlled trial by Lightower and Elliot (1977) showed that infiltration with lidocaine vs. placebo vs. no infiltration reduced the amount of pain associated with arterial puncture. However, there are numerous weaknesses to their trial design and write-up. Since, there have been no further published trials comparing subcutaneous local anaesthesia to placebo or controls which represents a significant gap in the literature.
More recently, topical anaesthetic agents have been shown to reduce the pain associated with venepuncture but no studies have shown topical agents to be beneficial for arterial puncture. To-date there is no good evidence to guide practice.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (≥18 years old) undergoing their first radial artery blood sampling as part of their normal care during hospital admission, will be included within the trial.
排除标准
- •Patients meeting any of the below criteria will be excluded:
- •Negative Allen's test - patients with no clinically visible connection between the radial and ulnar arteries will be excluded, as compromise of the radial artery through puncture and thrombosis may theoretically result in hand ischaemia.
- •Urgent ABG - patients requiring an urgent ABG (within 20 minutes) will be unable to fully consider the participant information sheet and consent, so will be excluded.
- •GCS <15 - patients who are not fully alert and orientated will be excluded as they cannot consent to participate and altered conscious levels may affect pain perception.
- •Prior failed ABG attempt on the contralateral limb.
- •Previous participation - this will be ascertained from the Trial folder (participants will have their JPUH Patient ID recorded).
结局指标
主要结局
Pain
时间窗: Immediate
Our primary outcome was pain experienced by patients during radial artery puncture, reported on a 10 cm Visual Analogue Scale (VAS). A VAS allows accurate pain assessment (being able to differentiate up to 1 mm or 1%) and does not limit responses unlike a Likert scale.
次要结局
- Success of ABG(Immediate)
- Use of systemic analgesia(Immediate)
- Need guage for local anaesthesia(Immediate)
- Needle gauge for ABG acquisition(Immediate)
- Movement during ABG acquisition(Immediate)
- Quality of Pulse(Immediate)
- Arterial blood biochemical parameters(Immediate)
- Preference for Local Anaesthesia(Post-hoc)
研究者
Mr Ryckie George Wade
Core Surgical Trainee
James Paget University Hospital NHS Foundation Trust