PDF(Pubmed)
Abstract：
BACKGROUND: Ultrasound-guided supraclavicular block (UGSCB) is an emerging technique gaining interest amongst emergency physicians that provides regional anaesthesia to the upper limb to tolerate painful procedures. It offers an alternative to the more traditional technique of a Bier block (BB). However, the effectiveness or safety of UGSCB when performed in the emergency department (ED) is unclear.
METHODS: SUPERB (SUPraclavicular block for Emergency Reduction versus Bier block) is a prospective open-label non-inferiority randomised controlled trial comparing the effectiveness of UGSCB versus BB for closed reduction of upper limb fractures and/or dislocations. Adult patients presenting with upper limb fracture and/or dislocation requiring closed reduction in ED were randomised to either UGSCB or BB. Once regional anaesthesia is obtained, closed reduction of the injured part was performed and immobilised. The primary outcome is maximal pain experienced during closed reduction measured via a visual analogue scale (VAS). Secondary outcomes include post-reduction pain, patient satisfaction, total opioid requirement in ED, ED length of stay, adverse events and regional anaesthesia failure.
RESULTS: Primary outcome analysis will be performed using both the intention-to-treat and per-protocol populations. The between-group difference in maximum pain intensity will be assessed using linear regression modelling with trial group allocation (UGSCB vs BB) included as a main affect. A pre-specified non-inferiority margin of 20 mm on the VAS scale will be used to establish non-inferiority of UGSCB compared to BB.
CONCLUSIONS: SUPERB is the first randomised controlled trial to investigate the effectiveness and safety of UGSCB in the ED. The trial has the potential to demonstrate that UGSCB is an alternative safe and effective option for the management of upper extremity emergencies in the ED.
METHODS: SUPERB (SUPraclavicular block for Emergency Reduction versus Bier block) is a prospective open-label non-inferiority randomised controlled trial comparing the effectiveness of UGSCB versus BB for closed reduction of upper limb fractures and/or dislocations. Adult patients presenting with upper limb fracture and/or dislocation requiring closed reduction in ED were randomised to either UGSCB or BB. Once regional anaesthesia is obtained, closed reduction of the injured part was performed and immobilised. The primary outcome is maximal pain experienced during closed reduction measured via a visual analogue scale (VAS). Secondary outcomes include post-reduction pain, patient satisfaction, total opioid requirement in ED, ED length of stay, adverse events and regional anaesthesia failure.
RESULTS: Primary outcome analysis will be performed using both the intention-to-treat and per-protocol populations. The between-group difference in maximum pain intensity will be assessed using linear regression modelling with trial group allocation (UGSCB vs BB) included as a main affect. A pre-specified non-inferiority margin of 20 mm on the VAS scale will be used to establish non-inferiority of UGSCB compared to BB.
CONCLUSIONS: SUPERB is the first randomised controlled trial to investigate the effectiveness and safety of UGSCB in the ED. The trial has the potential to demonstrate that UGSCB is an alternative safe and effective option for the management of upper extremity emergencies in the ED.
摘要：
背景：超声引导锁骨上阻滞（UGSCB）是一种新兴的技术，引起了急诊医师的兴趣，该技术为上肢提供区域麻醉以耐受疼痛的手术。它提供了Bier块（BB）的更传统技术的替代方案。然而,UGSCB在急诊科(ED)进行时的有效性或安全性尚不清楚.
方法：SUPERB（用于急诊复位的锁骨阻滞与Bier阻滞）是一项前瞻性开放标签非劣效性随机对照试验，比较UGSCB与BB用于上肢骨折和/或脱位闭合复位的有效性。患有需要闭合复位的上肢骨折和/或脱位的成年患者随机接受UGSCB或BB治疗。一旦获得区域麻醉，对受伤部位进行闭合复位并固定。主要结果是通过视觉模拟量表（VAS）测量的闭合复位过程中经历的最大疼痛。次要结果包括减少后疼痛，患者满意度,ED中的阿片类药物总需求量，ED停留时间，不良事件和区域麻醉失败。
结果：主要结果分析将使用意向治疗和符合方案的人群进行。最大疼痛强度的组间差异将使用线性回归模型进行评估，其中试验组分配（UGSCBvsBB）作为主要影响。在VAS量表上预先指定的20mm的非劣效性界限将用于确定UGSCB与BB相比的非劣效性。
结论：SUPERB是第一个研究UGSCB在ED中的有效性和安全性的随机对照试验。该试验有可能证明UGSCB是ED上肢紧急情况管理的另一种安全有效的选择。
方法：SUPERB（用于急诊复位的锁骨阻滞与Bier阻滞）是一项前瞻性开放标签非劣效性随机对照试验，比较UGSCB与BB用于上肢骨折和/或脱位闭合复位的有效性。患有需要闭合复位的上肢骨折和/或脱位的成年患者随机接受UGSCB或BB治疗。一旦获得区域麻醉，对受伤部位进行闭合复位并固定。主要结果是通过视觉模拟量表（VAS）测量的闭合复位过程中经历的最大疼痛。次要结果包括减少后疼痛，患者满意度,ED中的阿片类药物总需求量，ED停留时间，不良事件和区域麻醉失败。
结果：主要结果分析将使用意向治疗和符合方案的人群进行。最大疼痛强度的组间差异将使用线性回归模型进行评估，其中试验组分配（UGSCBvsBB）作为主要影响。在VAS量表上预先指定的20mm的非劣效性界限将用于确定UGSCB与BB相比的非劣效性。
结论：SUPERB是第一个研究UGSCB在ED中的有效性和安全性的随机对照试验。该试验有可能证明UGSCB是ED上肢紧急情况管理的另一种安全有效的选择。
