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临床试验/NCT03376100
NCT03376100已完成不适用

Ultrasound Guided Radial and Median Nerve Blocks Versus Haematoma Block for Closed Reduction of Distal Forearm Fractures; a Randomised Controlled Trial.

Regionshospitalet Viborg, Skive2 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
268
试验地点
2
主要终点
Reduction satisfaction

研究概览

简要总结

Randomized controlled trial comparing the standard haematoma block used for reduction of distal forearm fractures in the Emergency Department with ultrasound guided nerveblocks. The investigators hypothesize that ultrasound guided blocking of the radial and median nerves will improve fracture reduction satisfaction for the true Colles' fractures and improve analgesia for reduction of all distal forearm fracture types compared to the standard haematoma block.

详细描述

Multicenter randomized controlled trial comparing the standard hematoma block as the local anaesthetic procedure for reduction of distal forearm fracture with ultrasound guided radial and median nerve blocks.

Among all dislocated fractures of the distal forearm only the true Colles' fracture can potentially be treated adequately with a closed reduction and a cast, while the other fracture types are unstable by definition and require surgical stabilization. Most dislocated forearm fractures, however, require a primary reduction and this procedure requires the patient to be relieved of pain and the muscle traction on the fracture to be minimal. The conventional local anaesthetic procedure used in Denmark is the hematoma block where the local anaesthetic agent is injected directly in the fracture. This is done using either a blind technique or with the aid of X-ray to visualize the fracture line. The radial and median nerves supply periosteal innervation for the radius and the ulna as well as muscular innervation for the majority of muscles in the forearm and wrist. Blocking these nerves at the level of the cubital fossa should relieve pain and minimize muscular traction when performing closed reductions on distal forearm fractures.

The investigators hypothesize that ultrasound guided blocking of the radial and median nerves will improve fracture reduction satisfaction for the true Colles' fractures and improve analgesia for reduction of all fracture types compared to the standard haematoma block.

Patients eligible for screening for inclusion are identified in the Emergency Department (ED) at all recruitment sites upon primary contact. When an X-ray has revealed the relevant fracture, the ED-staff will call the available anaesthesiologist or anaesthesiologist trainee who will perform the inclusion process and randomisation. Participants will be randomized in either the intervention or the control group using the online randomization tool Research Electronic Data Capture (REDCap, Aarhus University, Denmark). In both groups, the reduction process will begin 10 minutes after the block has been performed. The technique for the actual reduction may vary amongst physicians. To best reflect the clinical practices and to avoid the risk of an insufficient reduction due to the physician being forced to comply to a technique unfamiliar to him, no further standardisation will be made in this regard. Following casting of the fracture a control X-ray will be performed and subsequently evaluated independently by two skilled orthopaedic surgeons to establish if the reduction was satisfactory. In case of disputes a third orthopaedic surgeon will evaluate the X-ray and make a final ruling. The fracture will be deemed satisfactory using a binary outcome measure (yes/no) if all the following requirements set by the National Clinical Guideline for Treatment of Distal Radius Fractures are met.

Binary data, including primary endpoint will be analysed using chi squared test. For normally distributed measurements the differences between groups will be compared using Student´s t-test. Variables considered not to be normally distributed will be analysed by Mann-Whitney´s U-test. Two-tailed P-values < 0.05 will be considered statistically significant.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of a closed distal forearm fracture in need of a closed reduction
  • Age > 18 years
  • Legally competent

排除标准

  • Inability to give informed consent
  • Allergy or intolerance towards local anaesthetics
  • Infection or burns at either injection site
  • Multi trauma (defined as other fractures or significant injuries)
  • Known pregnancy
  • Participation in other studies

研究组 & 干预措施

Control Group

Active Comparator

Patients with distal forearm fractures randomized to Hematoma Block.

干预措施: Hematoma Block (Procedure)

Intervention Group

Active Comparator

Patients with distal forearm fractures randomized to Ultrasound guided nerve block

干预措施: Ultrasound guided nerve blocks (Procedure)

结局指标

主要结局

Reduction satisfaction

时间窗: Within 8 hours from admission

Based on objective X-ray measures according to the Danish National Guideline for Treatment of Distal Forearm Fractures. The primary outcome applies for the true Colles' fractures only.

次要结局

  • Secondary fracture dislocation(Records obtained 2 months after primary treatment)
  • Pain, when local anaesthetic is injected(Within 8 hours from admission)
  • Pain, during reduction(Within 8 hours from admission)
  • Time spent on reduction(Within 8 hours from admission)

研究者

发起方
Regionshospitalet Viborg, Skive
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoffer Grant Sølling

Consultant, Head of Research, MD, PhD

Regionshospitalet Viborg, Skive

研究点 (2)

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