The Ultrasound Guided Infraclavicular Block: Decreased Incidence of Tourniquet Pain, Compared to Axillary Brachial Plexus Block?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Incidence of tourniquet pain
研究概览
简要总结
The purpose of this study is to determine whether the incidence of tourniquet pain is decreased if infraclavicular nerve block is administered, compared to axillary brachial plexus block, for surgical interventions at the level or distal to the elbow.
详细描述
Pneumatic tourniquets are often used in orthopedic surgery to ensure bloodless surgical field. Besides their obvious positive effects, arterial tourniquets have some unfavorable properties. One of these is tourniquet pain, which can manifest in the presence of an otherwise adequate neuraxial or peripheral nerve block. If it develops, it is usually difficult to manage, and can be severe enough to necessitate conversion to general anaesthesia.
In the past the incidence of tourniquet pain, associated with different nerve blocks has been estimated in clinical trials for which it was a secondary outcome measure. One recent meta-analysis addressed the question: is infraclavicular block (ICB) associated with a lesser incidence of tourniquet pain compared to other brachial plexus blocks. The studies selected by this meta-analysis used different types of nerve block. However it did not address the clinically relevant question: using standard techniques for ultrasound guided brachial plexus block (USgBPB) is the infraclavicular approach associated with a lesser incidence of tourniquet pain than the axillary approach? The following nerves contribute to the perception of tourniquet pain: musculocutaneous, radial, medial cutaneous brachial (MCBN) and intercostobrachial (ICBN). The potential advantage of the ICB over the axillary brachial plexus block (ABPB) in regards to tourniquet pain comes from anatomical reasons. In the pyramid shaped infraclavicular space the cords are much closer to each other; thus the likelihood of achieving effective MCBN and ICBN block is greater. The infraclavicular route has proven to result in an equally effective, reliable and safe block of the brachial plexus, compared to the axillary approach. We hypothesize that the incidence of tourniquet pain is less with infraclavicular block compared to axillary brachial plexus block.
The aim of the study is, to compare the incidence and severity of tourniquet pain associated with ultrasound guided ICB and ABPB in patients undergoing orthopedic surgery at the level or distal to the elbow, with a tourniquet time longer than 45 minutes.
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 (Investigator)
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
- •ASA I-III
- •Orthopedic surgery at the level or distal to the elbow
- •Expected tourniquet time > 45 min (K-wiring not suitable)
排除标准
- •Contraindication of regional anaesthesia, patient is allergic to local anesthetics
- •Clinically significant cognitive impairment (Minimental state score < 24)
- •Chronic pain syndrome
- •Preexisting nerve damage in the operated arm (sensory or motor deficit)
- •Axillary clearance in the past
- •History of peripheral neuropathy)
- •Pregnancy
研究组 & 干预措施
Infraclavicular Block
The patient will be positioned supine. The operating limb may be positioned abducted or adducted by side depending on operator preference and patient factors. After standard preparation, the needle will be directed towards the target area using an in-plane, short-axis technique. Local anaesthetic (lidocaine 2% with epinephrine 1:200.000) will be injected posterior to the artery with the intention achieving the U shape, cranio-postero-caudal spread. Local anaesthetic will be deposited to the lateral and medial cords as well, if required. The total dose of the local anaesthetic will be 20-30 ml, as clinically indicated.
干预措施: Ultrasound guided peripheral nerve block (Procedure)
Axillary Brachial Plexus Block
The patient will be positioned supine with the operative upper limb extended, flexed at the elbow, rested on a pillow to expose the axilla. After standard preparation, the needle will be directed towards the target area using an in-plane, short-axis technique. All four nerves in the axillary region are being blocked. The local anesthetic (lidocaine 2% with epinephrine 1:200.000, 15-25 ml) will be divided among the four nerves as clinically indicated by the spread, but at least 3 ml applied to each nerve.
干预措施: Ultrasound guided peripheral nerve block (Procedure)
结局指标
主要结局
Incidence of tourniquet pain
时间窗: Intraoperative period
次要结局
- Onset time of tourniquet pain(Intraoperative period)
- Block performance time(During block placement)
- Severity of tourniquet pain(Intraoperative period)
- Block onset time(30 minutes after block placement)
- Incidence of block failure(30 minutes after block placement)
- Incidence of adverse events(During block placement)
研究者
Dr. David Brenner
Principial Investigator
Cork University Hospital