【ChiCTR1900026870】Comparison of Wide Awake Local Anesthesia with No Tourniquet versus Regional and General Anesthesia in The Management of Distal Radius Fractures

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基本信息

登记号

ChiCTR1900026870

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2019-10-24

临床申请受理号

靶点

适应症

Distal radius Fracture

试验通俗题目

Comparison of Wide Awake Local Anesthesia with No Tourniquet versus Regional and General Anesthesia in The Management of Distal Radius Fractures

试验专业题目

Comparison of Wide Awake Local Anesthesia with No Tourniquet versus Regional and General Anesthesia in The Management of Distal Radius Fractures

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

75500

联系人通讯地址

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临床试验信息

试验目的

We hypothesized that WALANT for distal radius fractures is cost-effective, easy to use, safe, and has a high patient satisfaction rate as compared to the current practices of anaesthesia (general anaesthesia and Bier's block). Furthermore, we hypothesized that WALANT is a reproducible technique and does not require a high set of skills. To test these hypotheses, we compared various perioperative parameters, clinical outcome, and costs of general anaesthesia, Bier’s block, and WALANT techniques in a prospective cohort study.

试验分类

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试验类型

随机抽样

试验分期

治疗新技术

随机化

A system-generated randomization algorithm was created by the research office and delivered by a dedicated officer to ensure that the allocation sequence was concealed. The individual patient was allocated treatment on a non-probability consecutive basis.

盲法

double blinding

试验项目经费来源

Nil

试验范围

目标入组人数

58;55;56

实际入组人数

第一例入组时间

2016-03-03

试验终止时间

2019-04-30

是否属于一致性

入选标准

Participants included were patients with a unilateral closed fracture of the distal radius, that presented to our hospital within ten days of the initial injury；

排除标准

Exclusion criteria consisted of open fractures of the distal radius, bilateral distal radius fractures, and polytrauma patients requiring general anaesthesia or spinal anaesthesia for other injuries, such as long bone fractures, and traumatic brain injuries. In addition, patients that were anxious, non-cooperative, and those that did not consent to surgery were also excluded from the study protocol. Furthermore, patients with peripheral vascular disease, bleeding tendency, abnormal clotting profile, hypersensitivity to lidocaine, or active infection in the body were excluded from the study.；

研究者信息

研究负责人姓名

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试验机构

Jinnah Postgraduate Medical Centre (JPMC)

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研究负责人邮箱

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研究负责人邮编

75500

联系人通讯地址