ChiCTR1800014983 版本V1.0 版本创建时间2019/02/10 10:08:00 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：

 ChiCTR1800014983 

最近更新日期：

Date of Last Refreshed on：

 2018-02-26 23:45:55 

注册时间：

Date of Registration：

 2018-02-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The impact of two different injection dynamics on the diaphragmatic function after interscalene brachial plexus block

Public title：

The impact of two different injection dynamics on the diaphragmatic function after interscalene brachial plexus block

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The impact of two different injection dynamics on the diaphragmatic function after interscalene brachial plexus block: A prospective randomized trial

Scientific title：

The impact of two different injection dynamics on the diaphragmatic function after interscalene brachial plexus block: A prospective randomized trial

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：

Dr. Ali Elnabtity 

研究负责人：

Dr. Ali Elnabtity 

Applicant：

Dr. Ali Elnabtity 

Study leader：

Dr. Ali Elnabtity 

申请注册联系人电话：

Applicant telephone：

 +966 5 96785103

研究负责人电话：

Study leader's
telephone：

+966 5 96785103

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：

 alielnabtity@yahoo.com

研究负责人电子邮件：

Study leader's E-mail：

 alielnabtity@yahoo.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：

Palesten st. Jeddah, Saudi Arabia

研究负责人通讯地址：

Palesten st. Jeddah, Saudi Arabia

Applicant address：

Palesten st. Jeddah, Saudi Arabia

Study leader's address：

Palesten st. Jeddah, Saudi Arabia

申请注册联系人邮政编码：

Applicant postcode：

 21461

研究负责人邮政编码：

Study leader's postcode：

 21461

申请人所在单位：

Dr. Soliman Fakeeh Hospital

Applicant's institution：

Dr. Soliman Fakeeh Hospital

研究负责人所在单位：

Dr. Soliman Fakeeh Hospital

Affiliation of the Leader：

Dr.Soliman Fakeeh 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：

 01/REC/2018

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：

RESEARCH AND ETHICS COMMITTEE

Name of the ethic committee：

RESEARCH AND ETHICS COMMITTEE

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-02-01 00:00:00

伦理委员会联系人：

Dr. Amr Keera

Contact Name of the ethic committee：

Dr. Amr Keera

伦理委员会联系地址：

Palesteen st. Jeddah, Saudi Arabia

Contact Address of the ethic committee：

Palesteen st. Jeddah, Saudi Arabia

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +966 5 44639362

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：

Dr. Soliman Fakeeh Hospital

Primary sponsor：

Dr. Soliman Fakeeh Hospital

研究实施负责（组长）单位地址：

Palesteen st. Jeddah, Saudi Arabia

Primary sponsor's address：

Palesteen st. Jeddah, Saudi Arabia

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

沙特阿拉伯

省(直辖市)：

Jeddah

市(区县)：

Jeddah

Country：

Saudi Arabia

Province：

Jeddah

City：

Jeddah

单位(医院)：

Dr. Soliman Fakeeh Hospital

具体地址：

Palesteen st. Jeddah, Saudi Arabia

Institution
hospital：

Dr. Soliman Fakeeh Hospital

Address：

Palesteen st. Jeddah, Saudi Arabia

经费或物资来源：

Dr. Soliman Fakeeh Hospital

Source(s) of funding：

Dr. Soliman Fakeeh Hospital

研究疾病：

Diaphragmatic paresis  

Target disease：

Diaphragmatic paresis

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

We hypothesized that a slower, lower-pressure, titrated injection technique during interscalene brachial plexus block of shoulder surgeries, may limit spread of injectate to the phrenic nerve, with subsequent low incidence of diaphragmatic dysfunction after the operation.  

Objectives of Study：

We hypothesized that a slower, lower-pressure, titrated injection technique during interscalene brachial plexus block of shoulder surgeries, may limit spread of injectate to the phrenic nerve, with subsequent low incidence of diaphragmatic dysfunction after the operation.

药物成份或治疗方案详述：

Patients which are scheduled for shoulder surgeries are divided into 2 groups to be anesthetized by 2 different techniques. Interventions: Group 1 ( I min injection technique); Interscalene brachial plexus block( ISBPB) was performed by 20 ml of a local anesthetic mixture containing 12.5mLof 2% lidocaine and 12.5mL of 0.5% bupivacaine, injected along 1 min duration. Group 2 (5 min injection technique); ISBPB was performed by 20 ml of a local anesthetic mixture containing 12.5mLof 2% lidocaine and 12.5mL of 0.5% bupivacaine, injected along 5 min duration, 4 ml/min. 

Description for medicine or protocol of treatment in detail：

Patients which are scheduled for shoulder surgeries are divided into 2 groups to be anesthetized by 2 different techniques. Interventions: Group 1 ( I min injection technique); Interscalene brachial plexus block( ISBPB) was performed by 20 ml of a local anesthetic mixture containing 12.5mLof 2% lidocaine and 12.5mL of 0.5% bupivacaine, injected along 1 min duration. Group 2 (5 min injection technique); ISBPB was performed by 20 ml of a local anesthetic mixture containing 12.5mLof 2% lidocaine and 12.5mL of 0.5% bupivacaine, injected along 5 min duration, 4 ml/min. 

纳入标准：

Patients scheduled for elective shoulder arthroscopy for rotator cuff repair between the ages of 18-70 years old, with American Society of Anesthesiologists (ASA) physical status I-II of either sex, body mass index < 35, and mentally competent patients.

Inclusion criteria

Patients scheduled for elective shoulder arthroscopy for rotator cuff repair between the ages of 18-70 years old, with American Society of Anesthesiologists (ASA) physical status I-II of either sex, body mass index < 35, and mentally competent patients.

排除标准：

Exclusion criteria were patients with history of allergy or anaphylactic reaction to local anesthetics, coexisting acute or chronic pulmonary dysfunction, an existing neurological deficit in the upper limb, psychiatric disorders, and history of neck surgery or radiotherapy.

Exclusion criteria：

Exclusion criteria were patients with history of allergy or anaphylactic reaction to local anesthetics, coexisting acute or chronic pulmonary dysfunction, an existing neurological deficit in the upper limb, psychiatric disorders, and history of neck surgery or radiotherapy.

研究实施时间：

Study execute time：

从 From 2018-03-01 00:00:00至 To 2018-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-03-01 00:00:00 至 To 2018-07-31 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 60

Group：

Two groups

Sample size：

干预措施：

臂丛神经阻滞

干预措施代码：

Intervention：

two different injection dynamics of interscalene brachial plexus block

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 沙特阿拉伯

省(直辖市)：

 jeddah 

市(区县)：

  

Country：

Saudi Arabia

Province：

jeddah

City：

单位(医院)：

 Dr. Soliman Fakeeh Hospital 

单位级别：

 Tertiary hospital 

Institution
hospital：

Dr. Soliman Fakeeh Hospital

Level of the institution：

Tertiary hospital

测量指标：

Outcomes：

指标中文名：

diaphragmatic function as assessed by diaphragm movement

指标类型：

主要指标

Outcome：

diaphragmatic function as assessed by diaphragm movement

Type：

Primary indicator

测量时间点：

(immediately before, and 30 min after ISB, and 30 min after surgery in postanesthesia care unit

测量方法：

using the ultrasound

Measure time point of outcome：

(immediately before, and 30 min after ISB, and 30 min after surgery in postanesthesia care unit

Measure method：

using the ultrasound

指标中文名：

Pulmonary function test values(PFT) (FVC, FEV1, and PEF)

指标类型：

次要指标

Outcome：

Pulmonary function test values(PFT) (FVC, FEV1, and PEF)

Type：

Secondary indicator

测量时间点：

before ISB and 30 min after block, and 30 min after surgery in PACU,

测量方法：

bedside spirometer

Measure time point of outcome：

before ISB and 30 min after block, and 30 min after surgery in PACU,

Measure method：

bedside spirometer

指标中文名：

onset of the sensory and motor block

指标类型：

次要指标

Outcome：

onset of the sensory and motor block

Type：

Secondary indicator

测量时间点：

20 min after the block

测量方法：

using ice cubes for sensory block and arm movement for motor block

Measure time point of outcome：

20 min after the block

Measure method：

using ice cubes for sensory block and arm movement for motor block

指标中文名：

amount of fentanyl and propofol consumed during surgery

指标类型：

次要指标

Outcome：

amount of fentanyl and propofol consumed during surgery

Type：

Secondary indicator

测量时间点：

from start of surgery till the end

测量方法：

fentanyl (microgm), propofol (mg)

Measure time point of outcome：

from start of surgery till the end

Measure method：

fentanyl (microgm), propofol (mg)

指标中文名：

frequency of oxygen desaturation

指标类型：

次要指标

Outcome：

frequency of oxygen desaturation

Type：

Secondary indicator

测量时间点：

from start of surgery till the end

测量方法：

number of readings of pulseoximeter below 94%

Measure time point of outcome：

from start of surgery till the end

Measure method：

number of readings of pulseoximeter below 94%

指标中文名：

morphine consumption in the 1st day after surgery

指标类型：

次要指标

Outcome：

morphine consumption in the 1st day after surgery

Type：

Secondary indicator

测量时间点：

from the end of surgery and upto 24 hours

测量方法：

total amount in milligrams

Measure time point of outcome：

from the end of surgery and upto 24 hours

Measure method：

total amount in milligrams

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

no samples collection

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 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）：

Patients wil be randomised into group 1 and group 2 with a 1:1 allocation ratio. The allocated intervention was written on a slip of paper, placed in sealed serially numbered and opaque envelopes. The envelopes were serially opened, and the allocated intervention will be implemented. Randomization will be d

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

Patients wil be randomised into group 1 and group 2 with a 1:1 allocation ratio. The allocated intervention was written on a slip of paper, placed in sealed serially numbered and opaque envelopes. The envelopes were serially opened, and the allocated intervention will be implemented. Randomization will be d

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：

All investigators are blinded to which technique was being used ( the anesthetist who is doing the technique is not the one who is recording the outcomes.

Blinding：

All investigators are blinded to which technique was being used ( the anesthetist who is doing the technique is not the one who is recording the outcomes.

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）：

not available

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

not available

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 available

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

not available

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2018-02-26 23:45:55