Today is 2019-12-14

Ankle Fractures fixed in local anesthesia vs. spinal anesthesia
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注册号:

Registration number:

ChiCTR1900027410 

最近更新日期:

Date of Last Refreshed on:

2019-11-12 

注册时间:

Date of Registration:

2019-11-12 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Ankle Fractures fixed in local anesthesia vs. spinal anesthesia 

Public title:

Ankle Fractures fixed in local anesthesia vs. spinal anesthesia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

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

Scientific title:

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

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:

Department of Orthopaedics JPMC, Karachi, Pakistan 

研究负责人通讯地址:

Department of Orthopaedics JPMC, Karachi, Pakistan 

Applicant address:

Department of Orthopaedics JPMC, Karachi, Pakistan 

Study leader's address:

Department of Orthopaedics, JPMC, Karachi, Pakistan 

申请注册联系人邮政编码:

Applicant postcode:

75510 

研究负责人邮政编码:

Study leader's postcode:

75510 

申请人所在单位:

巴基斯坦卡拉齐真纳教学医学中心研究生医学中心 

Applicant's institution:

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/ 603/ 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:

2016-01-30 

伦理委员会联系人:

Prof. Shereen Z. Bhutta 

Contact Name of the ethic committee:

Prof. Shereen Z. Bhutta 

伦理委员会联系地址:

巴基斯坦卡拉齐真纳教学医学中心研究生医学中心 

Contact Address of the ethic committee:

Jinnah Postgraduate Medical Centre 

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:

Allah Rakhio Jamali 

Primary sponsor:

Allah Rakhio Jamali 

研究实施负责(组长)单位地址:

巴基斯坦卡拉齐真纳教学医学中心研究生医学中心 

Primary sponsor's address:

Jinnah Postgraduate Medical Centre 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

nil 

Source(s) of funding:

nil 

研究疾病:

Ankle Fractures 

Target disease:

Ankle Fractures 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

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. 

Objectives of Study:

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. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

半随机对照 

Study design:

Quasi-randomized controlled 

纳入标准:

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. 

Inclusion criteria

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. 

Exclusion criteria:

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. 

研究实施时间:

Study execute time:

From2016-02-09To 2019-06-21 

干预措施:

Interventions:

组别:

1

样本量:

74

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:

75

Group:

2

Sample size:

干预措施:

Spinal Anesthesia

干预措施代码:

Intervention:

Spinal Anesthesia

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

巴基斯坦 

省(直辖市):

信德 

市(区县):

卡拉齐 

Country:

Pakistan 

Province:

Sindh 

City:

Karachi 

单位(医院):

真纳教学医学中心 

单位级别:

 

Institution
hospital:

Jinnah Postgraduate Medical Centre  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

Postoperative Pain Score

指标类型:

主要指标 

Outcome:

Postoperative Pain Score

Type:

Primary indicator 

测量时间点:

24 hours after surgery

测量方法:

Visual Analogue Scale

Measure time point of outcome:

24 hours after surgery

Measure method:

Visual Analogue Scale

指标中文名:

Clinical Outcome

指标类型:

主要指标 

Outcome:

Clinical Outcome

Type:

Primary indicator 

测量时间点:

1 year

测量方法:

American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale

Measure time point of outcome:

1 year

Measure method:

American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale

指标中文名:

Clinical Outcome

指标类型:

主要指标 

Outcome:

Clinical Outcome

Type:

Primary indicator 

测量时间点:

Fracture Union

测量方法:

X-rays

Measure time point of outcome:

Fracture Union

Measure method:

X-rays

指标中文名:

Blood loss

指标类型:

主要指标 

Outcome:

Blood loss

Type:

Primary indicator 

测量时间点:

Intraoperative

测量方法:

Suction machine

Measure time point of outcome:

Intraoperative

Measure method:

Suction machine

指标中文名:

Patient Satisfaction

指标类型:

次要指标 

Outcome:

Patient Satisfaction

Type:

Secondary indicator 

测量时间点:

1 year

测量方法:

SF-12

Measure time point of outcome:

1 year

Measure method:

SF-12

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

Ankle Fracture

组织:

Sample Name:

Ankle 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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 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.

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.

盲法:

double blinding

Blinding:

double blinding

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

spss

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

spss

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 allowed

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

not allowed

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-12
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