Ultrasound Guided Hematoma Block vs. Blind Hematoma Block in Distal Radius Fractures, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Effectiveness of analgesia during closed reduction of a distal radius fracture
研究概览
简要总结
This study will investigate the effectiveness of analgesia of ultrasound hematoma block compared to 'blind' hematoma block in patients with dislocated distal radius fracture.
详细描述
Distal radius fractures represent one of the most common injuries in the Emergency Department (ED). Proper treatment especially for dislocated fractures can minimize the chance of residual injury. For closed reduction anesthesia is essential for safety, satisfaction and result. Different methods of regional anesthesia can be used but hematoma block (HB) is the technique most often used in EDs in the Netherlands and recommended by Dutch guidelines. In practice however a HB, does not always lead to adequate anesthesia, this might be because of poor infiltration into the fracture site. Ultrasound could additionally provide real-time guidance of injection into the fracture site, maximizing the analgesic effect of HB. In this study the effectiveness of analgesia of ultrasound HB will be compared to 'blind' HB in patients with a dislocated distal radius fracture.
Patients with a confirmed dislocated fracture of the distal radius requiring closed reduction will be randomized to either ultrasound guided hematoma block or normal 'blind' hematoma block. NRS-scores will be given before, during and after hematoma block and during and after reduction of the fracture. These scores will be the primary endpoint of this study.
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
Because treatment in both groups are different (one group with and one group without ultrasound) it's not possible to mask the treating physician for the intervention.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 16 years
- •Confirmed fracture of the distal radius requiring closed reduction, defined as any off the following items(7):
- •>10 degrees of dorsal angulation;
- •>20 degrees of volar angulation;
- •>2 mm step-off intra-articular;
- •>3 mm radial shortening;
- •>15 degrees radial inclination;
- •Translation and non-intact radio-carpal alignment in the lateral view
- •Significant translation in the posterior-anterior(PA)-view.
排除标准
- •No informed consent can be given (cognitive impairment, severe dementia, no knowledge of Dutch language e.a.)
- •Neurovascular compromise or open fractures requiring (immediate) surgery or reduction.
- •First reduction already performed
- •Multi-trauma patients requiring other urgent procedures/tests or with respiratory or hemodynamical compromise
- •Pre-existent osteosynthesis material in situ in the affected arm
- •Skin injury (with exception of minor abrasions), local infection or recent burns hindering or contra-indicating the use of ultrasound and ultrasound gel
- •Allergy for local anesthetics
结局指标
主要结局
Effectiveness of analgesia during closed reduction of a distal radius fracture
时间窗: NRS before, during and after (10-15 min) injection of hematoma block, NRS-score during closed reduction and after closed reduction (5 min)
Pain reduction will be measured on a Numeric Rating Scale( NRS-scale; 0-10) at different moments
次要结局
- Number of participants in which hematoma was aspirated during hematoma block(During hematoma block)
- Procedural time of the reduction(From moment physician is ready to start the reduction until cast is applied (up to maximum of 30 min.))
- Procedural time of the Hematoma block(Time from insertion of the needle until needle is withdrawn out of the patient (up to maximum of 30 min.))
- Satisfaction of reduction provided by physician performing reduction measured(10-15 minutes after closed reduction)
- Satisfaction of the nurse for procedure and reduction(10-15 minutes after closed reduction)
- Years of experience of treating physician with use of ultrasound.((up to) 10-15 minutes after last closed reduction attempt)
- Satisfaction of the patient for procedure and reduction(10-15 minutes after closed reduction)
- Number of reductions((up to) 10-15 minutes after last closed reduction attempt)
- Satisfaction of the HB provided by physician performing the HB procedure(10-15 minutes after hematoma block)
- Number of patients in which palpation of an evident step-off near fracture site was felt(During performing hematoma block)
- Years of experience of treating physician in performing HB.((up to) 10-15 minutes after last closed reduction attempt)
研究者
Pieter Veenstra
Principal investigator
Frisius Medisch Centrum