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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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注册号：

Registration number：

 ChiCTR1900026870 

最近更新日期：

Date of Last Refreshed on：

 2019-10-24 21:46:29 

注册时间：

Date of Registration：

 2019-10-24 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

WALANT

研究课题的正式科学名称：

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

Scientific title：

Comparison of Wide Awake Local Anesthesia with No Tourniquet versus Bier's block and General Anesthesia in The Management of Distal Radius Fractures

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Muhammad Tahir 

研究负责人：

Muhammad Tahir 

Applicant：

Muhammad Tahir 

Study leader：

Muhammad Tahir 

申请注册联系人电话：

Applicant telephone：

 +92 33 32343828

研究负责人电话：

Study leader's
telephone：

+92 33 32343828

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 doctor.muhammad.tahir@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 doctor.muhammad.tahir@gmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Jinnah Postgraduate Medical Centre (JPMC), Rafiqui Shaheed Road, Karachi, Pakistan

研究负责人通讯地址：

Jinnah Postgraduate Medical Centre (JPMC), Rafiqui Shaheed Road, Karachi, Pakistan

Applicant address：

Jinnah Postgraduate Medical Centre (JPMC), Rafiqui Shaheed Road, Karachi, Pakistan

Study leader's address：

Jinnah Postgraduate Medical Centre (JPMC), Rafiqui Shaheed Road, Karachi, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

 75500

研究负责人邮政编码：

Study leader's postcode：

 75500

申请人所在单位：

巴基斯坦卡拉齐真纳教学医学中心骨科

Applicant's institution：

Department of Orthopaedics, Jinnah Postgraduate Medical Centre

研究负责人所在单位：

巴基斯坦卡拉齐真纳教学医学中心骨科

Affiliation of the Leader：

Department of Orthopaedics, Jinnah Postgraduate Medical Centre

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 NO.F.2-81/ GENL-2016/ 11183Ab/ JPMC

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Medical Ethics Review Board

Name of the ethic committee：

Medical Ethics Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-02-11 00:00:00

伦理委员会联系人：

Prof. A. R. Jamali

Contact Name of the ethic committee：

Prof. A. R. Jamali

伦理委员会联系地址：

Medical Ethics Review Board JPMC

Contact Address of the ethic committee：

Medical Ethics Review Board JPMC

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Jinnah Postgraduate Medical Centre (JPMC)

Primary sponsor：

Jinnah Postgraduate Medical Centre (JPMC)

研究实施负责（组长）单位地址：

Jinnah Postgraduate Medical Centre (JPMC), Rafiqui Shaheed Road, Karachi, Pakistan

Primary sponsor's address：

Jinnah Postgraduate Medical Centre (JPMC), Rafiqui Shaheed Road, Karachi, Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

巴基斯坦

省(直辖市)：

Sindh

市(区县)：

卡拉齐

Country：

Pakistan

Province：

Sindh

City：

Karachi

单位(医院)：

真纳教学医学中心

具体地址：

Ward 14

Institution
hospital：

Jinnah Postgraduate Medical Centre

Address：

Ward 14

经费或物资来源：

Nil

Source(s) of funding：

nil

研究疾病：

Distal radius Fracture  

Target disease：

Distal radius Fracture

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

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.  

Objectives of Study：

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, Biers block, and WALANT techniques in a prospective cohort study.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2016-03-03 00:00:00至 To 2019-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2016-03-08 00:00:00 至 To 2018-06-06 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 55

Group：

1

Sample size：

干预措施：

WALANT

干预措施代码：

Intervention：

WALANT

Intervention code：

组别：

2

样本量：

 56

Group：

2

Sample size：

干预措施：

GA

干预措施代码：

Intervention：

GA

Intervention code：

组别：

3

样本量：

 58

Group：

3

Sample size：

干预措施：

Bier's block

干预措施代码：

Intervention：

Bier's block

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 Sindh 

市(区县)：

 卡拉齐 

Country：

Pakistan

Province：

Sindh

City：

Karachi

单位(医院)：

 Jinnah Postgraduate Medical Centre 

单位级别：

 三甲医院 

Institution
hospital：

Jinnah Postgraduate Medical Centre

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

Patient Reported Outcomes

指标类型：

主要指标

Outcome：

Patient Reported Outcomes

Type：

Primary indicator

测量时间点：

1 year

测量方法：

qDASH, VAS, PRWE, Mayo's wrist score

Measure time point of outcome：

1 year

Measure method：

qDASH, VAS, PRWE, Mayo's wrist score

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Distal Radius Fracture

组织：

Bone

Sample Name：

Distal Radius Fracture

Tissue：

Bone

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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.

Randomization Procedure (please state who generates the random number sequence and by what method)：

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.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

double blinding

Blinding：

double blinding

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

Not stated

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not stated

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Not stated

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2019-10-24 21:46:29
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