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

注册号： Registration number：	ChiCTR1800017602
最近更新日期： Date of Last Refreshed on：	2018-08-06 19:31:00
注册时间： Date of Registration：	2018-08-06 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	Analgesic Efficacy of Erector Spinae Plane Block after Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Clinical Trial
Public title：	Analgesic Efficacy of Erector Spinae Plane Block after Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Clinical Trial
注册题目简写：
English Acronym：
研究课题的正式科学名称：	Analgesic Efficacy of Erector Spinae Plane Block after Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Clinical Trial
Scientific title：	Analgesic Efficacy of Erector Spinae Plane Block after Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Clinical 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：	Ali Mohamed Ali Elnabtity	研究负责人：	Ali Mohamed Ali Elnabtity
Applicant：	Ali Mohamed Ali Elnabtity	Study leader：	Ali Mohamed Ali Elnabtity
申请注册联系人电话： Applicant telephone：	+20 0596785103	研究负责人电话： Study leader's telephone：	+20 0596785103
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：	Palesteen Street, Jeddah, KSA, Egypt	研究负责人通讯地址：	Palesteen Street, Jeddah, KSA, Egypt
Applicant address：	Palesteen Street, Jeddah, KSA, Egypt	Study leader's address：	Palesteen Street, Jeddah, KSA, Egypt
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：	Zagazig University, Egypt
Applicant's institution：	Zagazig University, Egypt
研究负责人所在单位：	Zagazig University, Egypt
Affiliation of the Leader：	Zagazig University, Egypt

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：	02/REC/2017	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：	2017-09-01 00:00:00
伦理委员会联系人：	Professor Dr. Amr Keera
Contact Name of the ethic committee：	Professor Dr. Amr Keera
伦理委员会联系地址：	Palesteen Street, Jeddah, KSA, Egypt
Contact Address of the ethic committee：	Palesteen Street, Jeddah, KSA, Egypt
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：

Dr. Soliman Fakeeh Hospital

Primary sponsor：

Dr. Soliman Fakeeh Hospital

研究实施负责（组长）单位地址：

Palesteen Street, Jeddah, KSA, Egypt

Primary sponsor's address：

Palesteen Street, Jeddah, KSA, Egypt

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	Egypt	省(直辖市)：	Zagazig	市(区县)：
Country：	Egypt	Province：	Zagazig	City：
单位(医院)：	Zagazig University	具体地址：	Palesteen Street, Jeddah, KSA, Egypt
Institution hospital：	Zagazig University	Address：	Palesteen Street, Jeddah, KSA, Egypt

经费或物资来源：

Dr. Soliman Fakeeh Hospital

Source(s) of funding：

Dr. Soliman Fakeeh Hospital

研究疾病：

postoperative pain control

Target disease：

postoperative pain control

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：

治疗新技术临床试验

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

Proper controlling of postoperative pain after percutaneous nephrolithotomy procedure by doing ultrasound-guided erector spinae plane block (ESPB) at the level of the thoracic vertebra number 11.

Objectives of Study：

Proper controlling of postoperative pain after percutaneous nephrolithotomy procedure by doing ultrasound-guided erector spinae plane block (ESPB) at the level of the thoracic vertebra number 11.

药物成份或治疗方案详述：

ESPB was performed in group B before induction of general anesthesia. Following routine standardized monitoring the patients were placed in the prone position. Skin preparation was performed using 10% povidone iodine. The block was performed using portable ultrasound device (SonoSite?, Bothell, WA, USA), with a linear 6–13 MHz ultrasound transducer. The probe was covered with a sterile cover.The blocks were performed at the T8 level of the spine using an in-plane technique. The T8 spinous process was located by palpating and counting down from the C7 spinous process. The ultrasound probe was then placed in a transverse position at this level to identify the tip of the T11 transverse process. The probe was then rotated into a longitudinal orientation where the erector spinae muscles can be identified superficial to the tip of the T11 transverse process. The patient's skin was anesthetized with 3 mL of 2% lidocaine. A 22G, 80-mm, insulated needle (B?Braun Sonoplex, Melsungen, Germany) was inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact was made with the T11 transverse process The location of the needle tip was confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process.. A total of 30 ml bupivacaine 0.25% was then injected into the ESP in group B. Local anesthesia distribution was observed in both cranial and caudal directions.Group C patients were given 30 ml of normal saline by the same procedure.

Description for medicine or protocol of treatment in detail：

ESPB was performed in group B before induction of general anesthesia. Following routine standardized monitoring the patients were placed in the prone position. Skin preparation was performed using 10% povidone iodine. The block was performed using portable ultrasound device (SonoSite?, Bothell, WA, USA), with a linear 6–13 MHz ultrasound transducer. The probe was covered with a sterile cover.The blocks were performed at the T8 level of the spine using an in-plane technique. The T8 spinous process was located by palpating and counting down from the C7 spinous process. The ultrasound probe was then placed in a transverse position at this level to identify the tip of the T11 transverse process. The probe was then rotated into a longitudinal orientation where the erector spinae muscles can be identified superficial to the tip of the T11 transverse process. The patient's skin was anesthetized with 3 mL of 2% lidocaine. A 22G, 80-mm, insulated needle (B?Braun Sonoplex, Melsungen, Germany) was inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact was made with the T11 transverse process The location of the needle tip was confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process.. A total of 30 ml bupivacaine 0.25% was then injected into the ESP in group B. Local anesthesia distribution was observed in both cranial and caudal directions.Group C patients were given 30 ml of normal saline by the same procedure.

纳入标准：

Inclusion criteria

排除标准：

The exclusion criteria included patients with psychological disorders, morbid obesity, hepatic or renal dysfunction, coagulation disorders, sepsis, history of chronic analgesic use, and history of allergy to local anesthetics.

Exclusion criteria：

The exclusion criteria included patients with psychological disorders, morbid obesity, hepatic or renal dysfunction, coagulation disorders, sepsis, history of chronic analgesic use, and history of allergy to local anesthetics.

研究实施时间：

Study execute time：

从 From 2017-09-02 00:00:00至 To 2018-12-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2017-09-02 00:00:00 至 To 2018-10-01 00:00:00

干预措施：

Interventions：

组别：	Group B	样本量：	25
Group：	Group B	Sample size：	25
干预措施：	ESPB by injecting 30 ml bupivacaine 0.25%	干预措施代码：
Intervention：	ESPB by injecting 30 ml bupivacaine 0.25%	Intervention code：

组别：	Group C	样本量：	25
Group：	Group C	Sample size：	25
干预措施：	ESPB by injecting 30 ml normal saline	干预措施代码：
Intervention：	ESPB by injecting 30 ml normal saline	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	Saudi Arabia	省(直辖市)：	Makka	市(区县)：	jeddah
Country：	Saudi Arabia	Province：	Makka	City：	jeddah
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：	Morphine consumption over 24h (mg)	指标类型：	主要指标
Outcome：	Morphine consumption over 24h (mg)	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 time to the first use of PCA	指标类型：	次要指标
Outcome：	The time to the first use of PCA	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	In the postoperative period, assessment for pain using NRS on	指标类型：	次要指标
Outcome：	In the postoperative period, assessment for pain using NRS on	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Sedation was assessed at 2, 6, 12, and 24 h using the Ramsay sedation scale	指标类型：	次要指标
Outcome：	Sedation was assessed at 2, 6, 12, and 24 h using the Ramsay sedation scale	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	patients satisfaction was assessed using a 5-point scale (1: very bad; 2: bad; 3: good; 4: very good; 5: perfect).	指标类型：	次要指标
Outcome：	patients satisfaction was assessed using a 5-point scale (1: very bad; 2: bad; 3: good; 4: very good; 5: perfect).	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Duration of surgery	指标类型：	次要指标
Outcome：	Duration of surgery	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	nausea and vomiting	指标类型：	副作用指标
Outcome：	nausea and vomiting	Type：	Adverse events
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：		组织：
Sample Name：	no sample	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	65	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 were randomized 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 to determine which group the patient would be included in. The anesthesiologist performing the randomization (A

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

Patients were randomized 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 to determine which group the patient would be included in. The anesthesiologist performing the randomization (A

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：	Both investigators and patients were blind to which method was being used.
Blinding：	Both investigators and patients were blind to which method was being used.

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 stated
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：	none
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：	2018-08-06 19:31:00