NCT06329752Unknown不适用
Ultrasound-guided Sciatic Nerve Block for Distal Leg and Ankle Fracture Manipulation in the Emergency Department: A Feasibility Study
Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To assess the technical feasibility of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures.
研究概览
简要总结
The goal of this feasibility clinical trial is to assess the acceptability of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures.
The trial aims to assess:
- The acceptability of sciatic nerve block
- The technical feasibility of sciatic nerve block
- The technical success of sciatic nerve block
- The analgesic efficacy of sciatic nerve block
In addition to that, this study aims to
- Describe patient-reported and physician-reported satisfaction
- Assess the Adverse Event rate at 48 hours post intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Confirmed radiological diagnosis of distal tibia fracture (Group 43 according to AO classification, all subtypes included); or malleolar fracture (Group 44 according to AO classification, all subtypes included); or distal fibula fracture (Group 4F3 according to AO classification, both the two subtypes included); or any combination of the fracture patterns described
- •Fractures requiring manipulation in the ED to achieve temporary stabilization either as manual reduction and cast immobilization; or calcaneal pin traction (as per local policy or treating physician's preference)
- •Capacity to understand the aim of the study, the potential benefits and harms of the proposed intervention
- •Capacity to provide consent
- •Capacity to provide a self-assessment of pain using the written VAS Scale
排除标准
- •Fractures that do not require any form of manipulation in the ED according to the treating physician (e.g., fractures with minimal or no displacement of the bony fragments, that are immobilized in a posterior leg cast by the nursing stuff/physicians assistants without any painful manipulations of the bony fragments performed by the physician)
- •Open fractures
- •Perisynthetic or periprosthetic fractures
- •Distal leg/ankle fractures with neurovascular compromise
- •Clinical signs of compartment syndrome
- •Skin infection at the needle entry sites
- •Diabetic neuropathy or any other known form of neuropathy that causes reduced sensation in the sciatic and/or femoral nerve territory
- •Charcot-Marie-Tooth disease
- •Known allergy to local anaesthetics or opioids
- •Hemodynamic instability
- •Known diagnosis of severe cognitive impairment
- •Dementia and/or delirium (defined by a 4AT score ≥ 2)
- •Lack of capacity to provide consent and to understand the aim of the study
- •Patient's refusal to participate in the study
- •Body weight < 40 Kg
研究组 & 干预措施
Sciatic Nerve block Arm (Single Arm)
Experimental
干预措施: Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine) (Procedure)
结局指标
主要结局
To assess the technical feasibility of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures.
时间窗: From patient recruitment until sciatic nerve scanning (an estimated time frame of 30 minutes)
Percentage of patients for whom the block is deemed technically feasible by the investigator in charge of this task
次要结局
- Technical success of US-guided sciatic nerve block(15 Minutes post US-guided sciatic nerve block)
- Analgesic efficacy of US-guided sciatic nerve block(An estimated average time of 15 minutes after the beginning of fracture manipulation)
- Patient-reported and physician-reported satisfaction(An estimated average time of 30 minutes after the beginning of fracture manipulation)
研究者
Santi Di Pietro
Emergency Medicine Consultant
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (2)
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