ChiCTR1900021592 版本V1.1 版本创建时间2019/06/12 16:06:49 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR1900021592 

最近更新日期：

Date of Last Refreshed on：

 2019-06-12 16:06:29 

注册时间：

Date of Registration：

 2019-02-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Real-time Ultrasound Guided Spinal Anaesthesia: Comparison of the Transverse Interspinous In-plane and Paramedian Saggital Oblique In-plane Injection Techniques

Public title：

Real-time Ultrasound Guided Spinal Anaesthesia: Comparison of the Transverse Interspinous In-plane and Paramedian Saggital Oblique In-plane Injection Techniques

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Real-time Ultrasound Guided Spinal Anaesthesia: Comparison of the Transverse Interspinous In-plane and Paramedian Saggital Oblique In-plane Injection Techniques

Scientific title：

Real-time Ultrasound Guided Spinal Anaesthesia: Comparison of the Transverse Interspinous In-plane and Paramedian Saggital Oblique In-plane Injection Techniques

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：

Ms Winnie Samy 

研究负责人：

Prof. Manoj K Karmakar 

Applicant：

Ms Winnie Samy 

Study leader：

Prof. Manoj K Karmakar 

申请注册联系人电话：

Applicant telephone：

 +852 3505 2735

研究负责人电话：

Study leader's
telephone：

+852 3505 2735

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：

 wsamy@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 karmakar@cuhk.edu.hk

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：

中國香港特別行政區新界沙田威爾斯親王醫院麻醉與重症監護部

研究负责人通讯地址：

中國香港特別行政區新界沙田威爾斯親王醫院麻醉與重症監護部

Applicant address：

Dept of Anaesthesia & Intensive Care, 4/F Prince of Wales Hospital, Shatin

Study leader's address：

Dept AIC, 4/F, Prince of Wales Hospital, Shatin, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

威爾斯親王醫院麻醉與重症監護部

Applicant's institution：

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital, CUHK

研究负责人所在单位：

威爾斯親王醫院麻醉與重症監護部

Affiliation of the Leader：

Dept of Anaesthesia & Intensive Care

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：

 CREC 2018.617-T

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

The Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-01-22 00:00:00

伦理委员会联系人：

Jenny Ng

Contact Name of the ethic committee：

Jenny Ng

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾斯親王醫院呂志和臨床科學大樓8樓

Contact Address of the ethic committee：

8/F Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35053935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 www.crec.cuhk.edu.hk

研究实施负责（组长）单位：

香港中文大學威爾斯親王醫院麻醉與重症監護部

Primary sponsor：

Dept of Anaesthesia & Intensive Care, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

中國香港特別行政區新界沙田牛盛街威爾斯親王醫院4樓

Primary sponsor's address：

4/F Prince of Wales Hospital, 30 Ngan Shing street, Shatin, New Territories

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

香港中文大學威爾斯親王醫院

具体地址：

新界沙田牛盛街威爾斯親王醫院4樓

Institution
hospital：

The Chinese University of Hong Kong

Address：

4/F Prince of Wales Hospital, 30 Ngan Shing street, Shatin, New Territories

经费或物资来源：

香港中文大學威爾斯親王醫院麻醉與重症監護部

Source(s) of funding：

Department of Anaesthesia & Intensive Care, The Chinese University of Hong Kong

研究疾病：

Musculoskeletal system and connective tissue  

Target disease：

Musculoskeletal system and connective tissue

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：

 IV期临床试验 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The objective of this prospective, randomized study is to compare the cerebrospinal fluid (CSF) efflux time using either the traditional paramedian spinal anaesthesia using the Paramedian sagittal oblique (PMSO) window from the non-dependent side, or the transverse in-plane dependent (TIPD) technique from the dependent side, with the patient in the lateral decubitus position.  

Objectives of Study：

The objective of this prospective, randomized study is to compare the cerebrospinal fluid (CSF) efflux time using either the traditional paramedian spinal anaesthesia using the Paramedian sagittal oblique (PMSO) window from the non-dependent side, or the transverse in-plane dependent (TIPD) technique from the dependent side, with the patient in the lateral decubitus position.

药物成份或治疗方案详述：

This prospective, randomized study will involve performing real-time ultrasound guided spinal anaesthesia for patients scheduled for surgery under spinal anaesthesia (SA). It will be done either by scanning from the traditional paramedian sagittal oblique acoustic window to perform SA (PMSO approach) or from the transverse interspinous in-plane acoustic window to perform SA (TIPD approach). All patients will be lying on their left side and have the same local anaesthetic agents fro SA, and the dosage received will be calculated according to their body weight. 

Description for medicine or protocol of treatment in detail：

This prospective, randomized study will involve performing real-time ultrasound guided spinal anaesthesia for patients scheduled for surgery under spinal anaesthesia (SA). It will be done either by scanning from the traditional paramedian sagittal oblique acoustic window to perform SA (PMSO approach) or from the transverse interspinous in-plane acoustic window to perform SA (TIPD approach). All patients will be lying on their left side and have the same local anaesthetic agents fro SA, and the dosage received will be calculated according to their body weight. 

纳入标准：

Adult patients, American Society of Anesthesiologists (ASA) physical status I-III, age between 20 to 85 years, and patients scheduled to undergo elective groin, lower limb, lower abdominal gynaecological and urogenital surgery under spinal anesthesia.

Inclusion criteria

Adult patients, American Society of Anesthesiologists (ASA) physical status I-III, aged between 20 to 85 years, and patients scheduled to undergo elective groin, lower limb, lower abdominal gynaecological and urogenital surgery under spinal anesthesia.

排除标准：

Patient refusal or unwilling to participate in the study, ASA physical status > Ⅲ, spinal deformity, previous spine surgery, pregnancy, coagulopathy, allergy to local anesthetic drugs,
skin infection at the site of needle insertion, severe Cardiac disease like atrial stenosis, atrial fibrillation, ongoing ischemic heart disease, autonomic dysfunction, and sepsis

Exclusion criteria：

Patient refusal or unwilling to participate in the study, ASA physical status >III, spinal deformity, previous spine surgery, pregnancy, coagulopathy, allergy to local anesthetic drugs,
skin infection at the site of needle insertion, severe Cardiac disease like atrial stenosis, atrial fibrillation, ongoing ischemic heart disease, autonomic dysfunction, and sepsis

研究实施时间：

Study execute time：

从 From 2019-04-08 00:00:00至 To 2020-05-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-04-08 00:00:00 至 To 2020-04-07 00:00:00

干预措施：

Interventions：

组别：

PMSO group

样本量：

 20

Group：

PMSO group

Sample size：

干预措施：

Perform real-time ultrasound guided spinal anaesthesia by scanning from PMSO approach

干预措施代码：

Intervention：

Perform real-time ultrasound guided spinal anaesthesia by scanning from PMSO approach

Intervention code：

组别：

TIPD group

样本量：

 20

Group：

TIPD group

Sample size：

干预措施：

Perform real-time ultrasound guided spinal anaesthesia by scanning from TIPD approach

干预措施代码：

Intervention：

Perform real-time ultrasound guided spinal anaesthesia by scanning from TIPD approach

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 香港中文大學威爾斯親王醫院 

单位级别：

 香港中文大學威爾斯親王醫院 

Institution
hospital：

Prince of Wales Hospital, The Chinese University of Hong Kong

Level of the institution：

Prince of Wales Hospital, The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

CSF efflux time

指标类型：

主要指标

Outcome：

CSF efflux time

Type：

Primary indicator

测量时间点：

after the insertion of the spinal needle during spinal anaesthesia

测量方法：

defined as the time it takes for the first drop of CSF to efflux from the hub of the spinal needle after removal of the stylet

Measure time point of outcome：

after the insertion of the spinal needle during spinal anaesthesia

Measure method：

defined as the time it takes for the first drop of CSF to efflux from the hub of the spinal needle after removal of the stylet

指标中文名：

Time taken to perform spinal anaesthesia

指标类型：

次要指标

Outcome：

Time taken to perform spinal anaesthesia

Type：

Secondary indicator

测量时间点：

right after spinal anaesthesia

测量方法：

The time it takes from the skin puncture by the introducer of the spinal needle until the removal of the spinal needle and introducer from the patient's back

Measure time point of outcome：

right after spinal anaesthesia

Measure method：

The time it takes from the skin puncture by the introducer of the spinal needle until the removal of the spinal needle and introducer from the patient's back

指标中文名：

number of needle insertion and redirection attemtps

指标类型：

次要指标

Outcome：

number of needle insertion and redirection attemtps

Type：

Secondary indicator

测量时间点：

during spinal anaesthesia

测量方法：

count the number of needle insertion and redirection attemps to enter the subarachnoid space

Measure time point of outcome：

during spinal anaesthesia

Measure method：

count the number of needle insertion and redirection attemps to enter the subarachnoid space

指标中文名：

successful spinal anaethesia

指标类型：

次要指标

Outcome：

successful spinal anaethesia

Type：

Secondary indicator

测量时间点：

the end of operation

测量方法：

defined as the ability to complete the planned surgery under spinal anaesthesia. "failure of the spinal anaesthesia" defined as failure to access the subarachnoid space after multiple attempts (>5) or conversion to general anaesthesia or other modes of anaesthesia for the completion of the scheduled surgery

Measure time point of outcome：

the end of operation

Measure method：

defined as the ability to complete the planned surgery under spinal anaesthesia. "failure of the spinal anaesthesia" defined as failure to access the subarachnoid space after multiple attempts (>5) or conversion to general anaesthesia or other modes of anaesthesia for the completion of the scheduled surgery

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Nil

组织：

N/A

Sample Name：

nil

Tissue：

not applicable

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 20 岁 years
最大 Max age 85 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）：

After recruitment, subjects (both male and female) will be randomly allocated to receive real-time USG SI using either the TIPD or PMSO technique. The randomization sequence will be generated using an online randomization software (www.randomization.com) and prepared by a third party (Research assistant).

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

After recruitment, subjects (both male and female) will be randomly allocated to receive real-time USG SI using either the TIPD or PMSO technique. The randomization sequence will be generated using an online randomization software (www.randomization.com) and prepared by a third party (Research assistant).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

double blinding

Blinding：

double blinding

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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 applicable

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

not applicable

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：

paper CRF

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

paper CRF

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：

  2019-02-28 21:02:23