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【ChiCTR1900027410】Ankle Fractures fixed in local anesthesia vs. spinal anesthesia

基本信息
登记号

ChiCTR1900027410

试验状态

尚未开始

药物名称

/

药物类型

/

规范名称

/

首次公示信息日的期

2019-11-12

临床申请受理号

/

靶点

/

适应症

Ankle Fractures

试验通俗题目

Ankle Fractures fixed in local anesthesia vs. spinal anesthesia

试验专业题目

A Randomized Control Trial Comparing the Clinical and Postoperative Outcomes in Ankle Fixation managed under wide-awake local anesthesia versus spinal anesthesia

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

75510

联系人通讯地址
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临床试验信息
试验目的

To compare the postoperative pain levels between WALANT (Wide-awake local anesthesia with no tourniquet) patients undergoing ankle fracture fixation and spinal anesthesia patients. To document the intraoperative experience of the patient undergoing WALANT. To compare the clinical outcomes and patient satisfaction at 1 year after surgery.

试验分类
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试验类型

半随机对照

试验分期

其它

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.

盲法

double blinding

试验项目经费来源

nil

试验范围

/

目标入组人数

74;75

实际入组人数

/

第一例入组时间

2016-02-09

试验终止时间

2019-06-21

是否属于一致性

/

入选标准

1. Ankle fractures operated within 10 days of the initial injury; 2. Ankle fractures OTA/AO classification 44B1, 44B2, 44B3 44C1, 44C2 and 44C3; 3. Aged 18-60 years.;

排除标准

1. Patients that did not consent for WALANT; 2. Patients that did not consent for participation in the trial; 3. Ankle fractures with posterior malleolus requiring fixation; 4. Open Ankle Fractures; 5. Patients that did not follow up till 1 year; 6. Anxious patients; 7. Lidocaine hypersensitivity; 8. Peripheral vascular disease.;

研究者信息
研究负责人姓名
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试验机构

Allah Rakhio Jamali

研究负责人电话
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研究负责人邮箱
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研究负责人邮编

75510

联系人通讯地址
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