ChiCTR2000028730 版本V1.0 版本创建时间2022/03/25 18:10:40 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：

 ChiCTR2000028730 

最近更新日期：

Date of Last Refreshed on：

 2020-01-01 21:21:26 

注册时间：

Date of Registration：

 2020-01-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Randomized Comparison of Intrathecal Morphine Versus Standard Therapy on Post-Caesarean Delivery Quality of Recovery

Public title：

Randomized Comparison of Intrathecal Morphine Versus Standard Therapy on Post-Caesarean Delivery Quality of Recovery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Randomized Comparison of Intrathecal Morphine Versus Standard Therapy on Post-Caesarean Delivery Quality of Recovery

Scientific title：

Randomized Comparison of Intrathecal Morphine Versus Standard Therapy on Post-Caesarean Delivery Quality of Recovery

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：

Floria Ng 

研究负责人：

Dr LAU Lai Ning Lydia 

Applicant：

Floria Ng 

Study leader：

Dr LAU Lai Ning Lydia 

申请注册联系人电话：

Applicant telephone：

 +852 35053155

研究负责人电话：

Study leader's
telephone：

+852 35053034

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：

 floria_ng@yahoo.com.hk

研究负责人电子邮件：

Study leader's E-mail：

 lydialnlau@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：

A&IC Department PWH, 30-32 Ngan Shing Street, Shatin, NT, Hong Kong, China

研究负责人通讯地址：

A&IC Department PWH, 30-32 Ngan Shing Street, Shatin, NT, Hong Kong, China

Applicant address：

A&IC Department PWH, 30-32 Ngan Shing Street, Shatin, NT, Hong Kong, China

Study leader's address：

A&IC Department PWH, 30-32 Ngan Shing Street, Shatin, NT, Hong Kong, China

申请注册联系人邮政编码：

Applicant postcode：

 0000

研究负责人邮政编码：

Study leader's postcode：

 0000

申请人所在单位：

香港中文大學

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

Chinese University of Hong Kong

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：

 2019.384

伦理委员会批件附件：

Approved file of Ethical Committee：

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：

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：

 2019-09-26 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士親王醫院呂志和臨床科學大樓8/F

Contact Address of the ethic committee：

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

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：

研究实施负责（组长）单位：

Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong

Primary sponsor：

Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong

研究实施负责（组长）单位地址：

4/F, Main Clinical Block and Trauma Centre, Prince of Wales Hospital, NT, Hong Kong, China

Primary sponsor's address：

4/F, Main Clinical Block and Trauma Centre, Prince of Wales Hospital, NT, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Not Applicable

市(区县)：

Hong Kong

Country：

China

Province：

Not Applicable

City：

Hong Kong

单位(医院)：

PWH

具体地址：

As above

Institution
hospital：

PWH

Address：

As above

经费或物资来源：

Departmental funding

Source(s) of funding：

Departmental funding

研究疾病：

Parturients  

Target disease：

Parturients

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：

To measure the quality of recovery in parturients receiving intrathecal morphine versus standard oral therapy after elective cesarean delivery.  

Objectives of Study：

To measure the quality of recovery in parturients receiving intrathecal morphine versus standard oral therapy after elective cesarean delivery.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Elective cesarean delivery under single shot spinal anesthesia;
2. Lower segment cesarean delivery with planned Pfannestiel incision;
3. ASA (American Society of Anesthesiologists) Class 1 to 2;
4. Aged >=18 years old;
5. Willing and able to give consent.

Inclusion criteria

1. Elective cesarean delivery under single shot spinal anesthesia;
2. Lower segment cesarean delivery with planned Pfannestiel incision;
3. ASA (American Society of Anesthesiologists) Class 1 to 2;
4. Aged >=18 years old;
5. Willing and able to give consent.

排除标准：

1. Emergency cesarean delivery;
2. Indication for additional post-operative analgesics on top of usual departmental regime (e.g. classical cesarean, pre-eclampsia, post-partum hemorrhage);
3. Contraindicated to paracetamol or diclofenac (e.g. allergy, renal or liver impairment, asthma, peptic ulcer disease);
4. Allergic to morphine.

Exclusion criteria：

1. Emergency cesarean delivery;
2. Indication for additional post-operative analgesics on top of usual departmental regime (e.g. classical cesarean, pre-eclampsia, post-partum hemorrhage);
3. Contraindicated to paracetamol or diclofenac (e.g. allergy, renal or liver impairment, asthma, peptic ulcer disease);
4. Allergic to morphine.

研究实施时间：

Study execute time：

从 From 2020-02-03 00:00:00至 To 2022-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-05-04 00:00:00 至 To 2022-05-09 00:00:00

干预措施：

Interventions：

组别：

Placebo group

样本量：

 76

Group：

Placebo group

Sample size：

干预措施：

Intrathecal saline 0.1ml

干预措施代码：

Intervention：

Intrathecal saline 0.1ml

Intervention code：

组别：

morphine group

样本量：

 76

Group：

morphine group

Sample size：

干预措施：

intrathecal morphine 0.1ml

干预措施代码：

Intervention：

intrathecal morphine 0.1ml

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)：

 威爾士親王醫院 

单位级别：

 三级医院 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Tertiary institution

测量指标：

Outcomes：

指标中文名：

QoR-15 Questionnaire

指标类型：

主要指标

Outcome：

QoR-15 Questionnaire

Type：

Primary indicator

测量时间点：

at 24 hours after surgery

测量方法：

Measure time point of outcome：

at 24 hours after surgery

Measure method：

指标中文名：

American Pain Society Patient Outcome Questionnaire

指标类型：

次要指标

Outcome：

American Pain Society Patient Outcome Questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Incidence of clinically significant respiratory depression events

指标类型：

次要指标

Outcome：

Incidence of clinically significant respiratory depression events

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

Not Applicable

Tissue：

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 岁 years
最大 Max age 50 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

Intrathecal morphine and placebo groups will be numbered group 0 or 1 randomly with the assignment concealed in a sealed opaque envelope until after the final data analysis. After recruitment, patients will be randomly allocated into either groups in a 1:1 ratio using computer generated random number sequence.

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

Intrathecal morphine and placebo groups will be numbered group 0 or 1 randomly with the assignment concealed in a sealed opaque envelope until after the final data analysis. After recruitment, patients will be randomly allocated into either groups in a 1:1 ratio using computer generated random number sequence.

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：

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）：

protocol

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

protocol

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：

Data will be stored on an encrypted and password protected server in the Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong. Data will be kept confidential in secure offices of the Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong. Only grouped data will be published. The protocol will adhere to local laws, and complies with the Declaration of Helsinki, Principles of Good Clinical Practice and institutional policies. Approval for the project will be obtained from the Joint Chinese University of Hong Kong-New Terriroties East Cluster Clinical Research Ethics Committee.

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

Data will be stored on an encrypted and password protected server in the Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong. Data will be kept confidential in secure offices of the Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong. Only grouped data will be published. The protocol will adhere to local laws, and complies with the Declaration of Helsinki, Principles of Good Clinical Practice and institutional policies. Approval for the project will be obtained from the Joint Chinese University of Hong Kong-New Terriroties East Cluster Clinical Research Ethics Committee.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2020-01-01 21:21:26