简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
Multi-level Thoracic Paravertebral Block and Its Effects on Acute and Chronic Pain, and Health-Related Quality of Life after Major Breast Cancer Surgery
下载XML文档

注册号：

Registration number：

 ChiCTR-TRC-14004201 

最近更新日期：

Date of Last Refreshed on：

 2025-04-17 09:53:03 

注册时间：

Date of Registration：

 2014-01-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Multi-level Thoracic Paravertebral Block and Its Effects on Acute and Chronic Pain, and Health-Related Quality of Life after Major Breast Cancer Surgery

Public title：

Multi-level Thoracic Paravertebral Block and Its Effects on Acute and Chronic Pain, and Health-Related Quality of Life after Major Breast Cancer Surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Thoracic Paravertebral Block and the Risk of Developing Chronic Pain after Major Breast Cancer Surgery: A Prospective Randomizeda Single-level versus ulti-level ThoracicStudy ComparingParavertebral Block

Scientific title：

Thoracic Paravertebral Block and the Risk of Developing Chronic Pain after Major Breast Cancer Surgery: A Prospective Randomizeda Single-level versus ulti-level ThoracicStudy ComparingParavertebral Block

研究课题代号(代码)：

Study subject ID：

 CRE-2013.637-T

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：

CUHK_CCT00391

申请注册联系人：

Winnie Samy 

研究负责人：

Manoj K Karmakar 

Applicant：

Winnie Samy 

Study leader：

Manoj K Karmakar 

申请注册联系人电话：

Applicant telephone：

 +852 26323155

研究负责人电话：

Study leader's
telephone：

+852 26322737

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)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00391

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00391

申请注册联系人通讯地址：

Department of Anesthesia and Intensive Care, Prince of Wales Hospital

研究负责人通讯地址：

Department of Anesthesia and Intensive Care, Prince of Wales Hospital

Applicant address：

Department of Anesthesia and Intensive Care, Prince of Wales Hospital

Study leader's address：

Department of Anesthesia and Intensive Care, Prince of Wales Hospital

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：

Prince of Wales Hospital

Applicant's institution：

Prince of Wales Hospital

研究负责人所在单位：

Prince of Wales Hospital

Affiliation of the Leader：

Prince of Wales Hospital

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：

 2013.637-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：

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

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：

 2014-01-15 00:00:00

伦理委员会联系人：

Amy Li

Contact Name of the ethic committee：

Amy Li

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince ofWales Hospital, Shatin, HK

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince ofWales Hospital, Shatin, HK

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：

The Chinese University of Hong Kong, Prince of Wales Hospital

Primary sponsor：

The Chinese University of Hong Kong, Prince of Wales Hospital

研究实施负责（组长）单位地址：

30-32 Ngan Shing Street , Shatin, New Territories, Hong Kong, SAR, China

Primary sponsor's address：

30-32 Ngan Shing Street , Shatin, New Territories, Hong Kong, SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Not stated

省(直辖市)：

Not stated

市(区县)：

Not stated

Country：

Not stated

Province：

Not stated

City：

Not stated

单位(医院)：

Not stated

具体地址：

Not stated

Institution
hospital：

Not stated

Address：

Not stated

经费或物资来源：

Department resources (The Department of Anesthesia and Intensive Care)

Source(s) of funding：

Department resources (The Department of Anesthesia and Intensive Care)

研究疾病：

Breast cancer in females  

Target disease：

Breast cancer in females

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：

Objectives during Phase I (72-h postoperative): To determine the effects of a multi-level TPVB on acute postoperative pain, analgesic consumption and “Quality of Recovery” after BCS and compare these effects with that produced by a single-level TPVB. Objectives during Phase II (Telephone interview at 3 months, 6 months, 1 year, 2 year, 3 year, 4 year, and 5 year after surgery): To determine the effects of a multi-level TPVB on the incidence of chronic pain and “Quality of Life” after BCS and compare these effects with that produced by a single-level TPVB.  

Objectives of Study：

In this study, there are two study groups. In both groups three injections will be made in the back. In one group, local anesthetic will be injected in all the three levels; while in the other group, local anesthetic will be injected in one thoracic level and saline will be injected subcutaneously or intramuscularly in the other two levels. You will be assigned to one of the two groups randomly. There is 50:50 chance of each group which is determined by the allocation. No matter which drug is used, it will not affect your surgery because rescue analgesia will be administered whenever necessary during the surgery. The whole procedure will last approximately 20-30 minutes.

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：

The following patients will be excluded from the study: history of chronic pain, history of regular analgesic usage, contraindication to the use of non-steroidal anti-inflammatory drugs (NSAID), known allergy to local anaesthetic drugs, infection at the site of block placement, bleeding tendency or with evidence of coagulopathy, pre-existing neurological or muscular disorders, history of psychiatric illness, pregnant patients, pre-existing nausea or vomiting, patients who received opioid or drugs with antiemetic properties in the 24 h before surgery, patients who received radiotherapy before surgery and patients with breast pain before surgery.

Exclusion criteria：

The following patients will be excluded from the study: history of chronic pain, history of regular analgesic usage, contraindication to the use of non-steroidal anti-inflammatory drugs (NSAID), known allergy to local anaesthetic drugs, infection at the site of block placement, bleeding tendency or with evidence of coagulopathy, pre-existing neurological or muscular disorders, history of psychiatric illness, pregnant patients, pre-existing nausea or vomiting, patients who received opioid or drugs with antiemetic properties in the 24 h before surgery, patients who received radiotherapy before surgery and patients with breast pain before surgery.

研究实施时间：

Study execute time：

从 From 2015-07-01 00:00:00至 To 2029-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-07-05 00:00:00 至 To 2024-02-02 00:00:00

干预措施：

Interventions：

组别：

Group I

样本量：

 110

Group：

Group I

Sample size：

干预措施：

Local anesthetic will be injected in one thoracic level and saline will be injected subcutaneously or intramuscularly in the other two levels

干预措施代码：

Intervention：

Ultrasound guided multi-level thoracic paravertebral nerve block: In one group, local anesthetic will be injected in all the three levels; while in the other group, local anesthetic will be injected in one thoracic level and saline will be injected subcutaneously or intramuscularly in the other two levels.

Intervention code：

组别：

Group II

样本量：

 110

Group：

Group II

Sample size：

干预措施：

Local anesthetic will be injected in all the three levels

干预措施代码：

Intervention：

Local anesthetic will be injected in all the three levels

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Chinese University of Hong Kong 

单位级别：

 University 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Acute postoperative pain

指标类型：

主要指标

Outcome：

Acute postoperative pain

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Analgesic consumption

指标类型：

主要指标

Outcome：

Analgesic consumption

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Quality of Recovery

指标类型：

主要指标

Outcome：

Quality of Recovery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

The incidence of chronic pain

指标类型：

次要指标

Outcome：

The incidence of chronic pain

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Quality of Life

指标类型：

次要指标

Outcome：

Quality of Life

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：

未说明

组织：

Sample Name：

Not stated

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 30 岁 years
最大 Max age 75 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）：

The randomization sequence will be generated using online randomization software (www.randomization.com).

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

The randomization sequence will be generated using online randomization software (www.randomization.com).

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-blind (The principle investigator (MK) will prepare the drug and supervise all TPVB and general anesthesia. All of the participants, Surgeons, a research nurse who will record data in the recovery room and at regular intervals in the postoperative ward and who will also conduct the telephone interview, the ward nurse assigned to care for the patient during out of office hours (1700h – 0800 h) will be all blinded to the study groups.)

Blinding：

Double-blind (The principle investigator (MK) will prepare the drug and supervise all TPVB and general anesthesia. All of the participants, Surgeons, a research nurse who will record data in the recovery room and at regular intervals in the postoperative ward and who will also conduct the telephone interview, the ward nurse assigned to care for the patient during out of office hours (1700h – 0800 h) will be all blinded to the study groups.)

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

否No

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）：

None

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

None

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：

注册人：

Name of Registration：

  2014-01-25 00:00:00
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统