Ultrasound-guided Block of the Supraclavicular Nerves for Clavicular Fractures in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale
研究概览
简要总结
A Clavicular fractures (CF) is uncomfortable for the affected patients because the fragments are often strongly displaced by the muscles attached to them and the bony fragments move painfully with every movement of the shoulder. In emergency departments (ED), so far CF has been tackled with drugs that are taken by mouth or injected into a vein. This type of pain management has many side effects since these painkillers act systemically.
The aim of the study is to investigate the effectiveness of pain relief in CF to be operated using regional anaesthesia. For this purpose, the supraclavicular nerves (SCN), which run directly under the skin of the neck, will be located using an ultrasound device (US). Under US-guidance the injection needle approaches the SCN and 2-3 millilitres of local aesthetic (LA) are injected around the nerves. The pain relief may last 12 up to 24 hours, which bridges the time until the operation (OP).
In order to compare this procedure, CF-patients will be divided into two groups, of which the control group (21) will be treated with painkillers in the conventional manner and the intervention group (21) will receive the US-guided block of the SCN.
With the small amount of LA injected, adverse events (AE) are very rare. Nevertheless, the puncture in the side of the neck may cause bruises at the site of the injection or uncomfortable, spreading pain. Systemic side effects are unlikely.
In the intervention group, the investigators expect a nearly complete pain relief up to the operation than with conventional pain therapy and a lower rate of side effects than with systemic administration of painkillers.
详细描述
In 2013 Tran and colleagues reported about a controversial knowledge concerning the sensory innervation of the clavicle which may lead to different approaches of regional analgesia (RA) in CF: superficial cervical plexus blocks, interscalene blocks, and combined superficial cervical plexus-interscalene blocks. Since the innervation of the clavicle comes from four nerves (supraclavicular nerves, subclavian nerve, long thoracic nerve and suprascapular nerve) it seams to be quite difficult to guarantee a complete sensible clavicular block for an operation. Nevertheless, few case reports exist, witch describe clavicle operations under RA alone. However, in these cases a considerable amount of local anaesthetics (LA) has been used that it may be assumed that there could have been dangerous side effects.
Valdés-Vilches and Sánchez-del Águila pronounced the importance of the supraclavicular nerves (SCN) in CF. For that reason, our purpose is to determine the effectivity of a single nerve block of SCN in CF in the ED with only 2-3 millilitres of LA. The aim of our study is to investigate the effectiveness of this method in CF to be operated up to 24 hours later. For this purpose, the SCN, which run directly under the skin of the neck, will be located using an ultrasound device (US). Under US-guidance the injection needle approaches the SCN and 2-3 millilitres of LA are injected around the nerves. The pain relief may last 12 up to 24 hours, which bridges the time until the operation (OP).
In order to compare this new procedure, CF-patients will be divided into two groups, of which the control group (20) will be treated with painkillers in the conventional manner and the intervention group (20) will receive the US-guided block of the SCN.
The following medical products and medicaments will be used, which are all already registered and authorised in Switzerland:
- US-machines: Samsung HS60 High-End with linear-probe (array) LA4-18BD; Samsung RS85 Premium Radiology with linear probe LA4-18B.
- Needle: PAJUNK SonoTAP 24 Gauge x 40mm
- LA: 3 ml Bupivacaine 0.5% +75mcg Clonidine as an adjuvant. The LA will be used in accordance with the prescribing information. The dose will be up to 10 fold lower than the usual used dosages in cervical nerve blocks, since with US-guidance there will be an excellent accuracy to approach the desired single nerve.
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
盲法说明
The comparator group will get systemic conventional pain management. Pain management using placebo would be harmful in patients with clavicular fractures. If these patients will have a severely dislocated fracture, they will be scheduled to have internal fixation of the fracture within the next 24 hours. They will receive oral and intravenous pain management.
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
- •adult ED-patients with sonographic and / or radiologically diagnosed clavicular fracture, who are scheduled for operation within the next 24 hours
- •older then 18 years
- •no known allergies to local anesthetic drugs
排除标准
- •refusal of the procedure by the patient
- •infection at the site of possible injection of local anaesthetics
- •known allergies against local anaesthetics
- •inability of consent or no carer
研究组 & 干预措施
Group 1: Control
Systemic conventional pain management. Adult patients with acute fractures of the clavicle, who are scheduled to have internal fixation of the fracture within the next 24 hours receive oral and intravenous pain management.
干预措施: Conventional pain management (Drug)
Group 2: Nerve Block
Adult patients with acute fractures of the clavicle, who are scheduled for an internal fixation of the fracture within the next 24 hours will receive an ultrasound-guided block of the supraclavicular nerves using a maximum of 3 ml of a long-acting local anesthetic. The injection is carried out directly in the emergency department following a sonographic or radiological diagnosis.
干预措施: Ultrasound-guided block of the supraclavicular nerves (Procedure)
结局指标
主要结局
Numeric Rating Scale
时间窗: within the first 24 hours after ED-Admission or until the operation
The numerical rating scale (NRS) is one of the most widely used pain rating scales. It ranges from zero to ten, with zero being no pain and ten being the worst possible pain. The measurement of the NRS is achieved using the patient evaluation sheet.
次要结局
- Incidence of side effects(within the first 24 hours after ED-Admission)
- Painkillers in milligrams until surgery(within the first 24 hours after ED-Admission or until the operation)
- Patient Questionnaire(Within the first 24 hours after ED-Admission or after operation)
- Painkillers in milligrams after surgery(within the first 24 hours after ED-Admission after the operation)
研究者
Eckehart SCHÖLL
Head of Emergency Department
Merian Iselin Klinik