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Analgesic Efficacy of Erector Spinae Plane Block after Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Clinical Trial
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注册号:

Registration number:

ChiCTR1800017602 

最近更新日期:

Date of Last Refreshed on:

2018-08-06 

注册时间:

Date of Registration:

2018-08-06 

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 

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 

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.  

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

Inclusion criteria were patients with American Society of Anesthesiologists (ASA) physical status Classes I and II, aged 18–65 years, and scheduled for first-stage unilateral PCNL to extract stones which are large, multiple, or resistant to shockwave lithotripsy from the upper ureter and the pelvicalyceal system. 

Inclusion criteria

Inclusion criteria were patients with American Society of Anesthesiologists (ASA) physical status Classes I and II, aged 18–65 years, and scheduled for first-stage unilateral PCNL to extract stones which are large, multiple, or resistant to shockwave lithotripsy from the upper ureter and the pelvicalyceal system. 

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:

From2017-09-02To 2018-12-01 

干预措施:

Interventions:

组别:

Group B

样本量:

25

Group:

Group B

Sample size:

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:

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 years
最大 Max age 65 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

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.

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-08-06
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