Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,716
- 试验地点
- 1
- 主要终点
- Cumulative proportion of patients with distal radius fracture surgery
研究概览
简要总结
The aim of the project is to evaluate the beneficial and harmful effects of an ultrasound-guided brachial plexus nerve block for patients with a distal radius (wrist) fracture in the need of realignment of fractured bone endings without cutting the skin (closed reduction), in comparison to a haematoma block, which is standard care in Denmark.
Every participant will receive one of the following types of anaesthesia for the realignment of the wrist fracture:
- A nerve block of the arm (plexus brachialis block)
- A haematoma block, which is the current standard anaesthesia in the emergency departments.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the nature of the intervention, it is unfeasible to blind the patients, the doctor who performs the brachial plexus nerve block and the doctor who performs the standard care and the closed reduction. As a result, data on patient evaluated outcomes, i.e. maximum pain score during closed reduction; maximum pain within the first 24 hours after closed reduction; pain at rest; discomfort related to the anaesthetic procedure; overall satisfaction with the treatment; PRWE; DASH; EQ-5D-5L; and data on the closed reduction, i.e. number of attempts used for closed reduction and difficulty of closed reduction of the fracture, will be reported unblinded. Importantly, other caregivers and all outcome assessors are blinded, including the doctor who evaluate the radiographic results and assess the need for surgery, as well as all personnel involved in the subsequent outcome evaluations.
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
- •Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction
排除标准
- •Patients who would never qualify for surgery according to local guidelines
- •Lack of informed consent
- •No Danish Central Person Register (CPR) number
- •Allergies to the trial medication
- •Distal radius fracture initially deemed to require surgery regardless of the outcome of the closed reduction
- •Open fractures (fracture-related wound requiring sutures)
- •Other fractures on the same extremity ((NOT including distal ulna fracture(s))
- •Bilateral distal radius fractures both requiring closed reduction
- •Concomitant medical or surgical condition taking priority over the closed reduction of the distal radius fracture.
结局指标
主要结局
Cumulative proportion of patients with distal radius fracture surgery
时间窗: 90 days after closed reduction
次要结局
- Composite outcome of treatment related complications(90 days after closed reduction)
- Patient Rated Wrist Evaluation (PRWE)(90 days after closed reduction)
- Maximum pain score in the affected wrist during closed reduction(s)(0-12 hours after the closed reduction)
- Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction(0 -24 hours after closed reduction)