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Rhomboid intercostal block versus Rhomboid intercostal block combined with serratus plane block for postoperative analgesia after video-assisted thoracoscopic surgery: a double-blind randomized controlled trial.
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注册号:

Registration number:

ChiCTR2000038264 

最近更新日期:

Date of Last Refreshed on:

2020-12-07 

注册时间:

Date of Registration:

2020-09-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

超声引导下菱形肋间神经阻滞与菱形肋间神经阻滞联合前锯肌神经阻滞在胸科手术中的应用 

Public title:

Rhomboid intercostal block versus Rhomboid intercostal block combined with serratus plane block for postoperative analgesia after video-assisted thoracoscopic surgery: a double-blind randomized controlled trial. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

超声引导下菱形肋间神经阻滞与菱形肋间神经阻滞联合前锯肌神经阻滞在胸科手术中的应用 

Scientific title:

Rhomboid intercostal block versus Rhomboid intercostal block combined with serratus plane block for postoperative analgesia after video-assisted thoracoscopic surgery: a double-blind randomized controlled 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:

邓威 

研究负责人:

邓威 

Applicant:

Wei Deng 

Study leader:

Wei Deng 

申请注册联系人电话:

Applicant telephone:

+86 19884340796 

研究负责人电话:

Study leader's telephone:

+86 19884340796 

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:

dengwei1992868@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dengwei1992868@163.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:

中国浙江嘉兴南湖区杨柳湾路23号紫欣公寓1栋406 

研究负责人通讯地址:

中国浙江嘉兴南湖区杨柳湾路23号紫欣公寓1栋406 

Applicant address:

Room 406, Building1, Zixin Apartment, 23 Yangliuwan Road, Nanhu District, Jiaxing, Zhejiang, China 

Study leader's address:

Room 406, Building1, Zixin Apartment, 23 Yangliuwan Road, Nanhu District, Jiaxing, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

314000 

研究负责人邮政编码:

Study leader's postcode:

314000 

申请人所在单位:

嘉兴第一医院 

Applicant's institution:

Jiaxing First 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:

LS2020-298 

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:

嘉兴第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Jiaxing First Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-17 

伦理委员会联系人:

李振平 

Contact Name of the ethic committee:

Zhenping Li 

伦理委员会联系地址:

浙江省嘉兴市中环南路1882号 

Contact Address of the ethic committee:

1882 Zhonghuan Road South, Jiaxing, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 19884340796 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

dengwei1992868@163.com 

研究实施负责(组长)单位:

浙江省嘉兴市嘉兴第一医院 

Primary sponsor:

Jiaxing First Hospital, Jiaxing, Zhejiang  

研究实施负责(组长)单位地址:

中国浙江嘉兴南湖区杨柳湾路23号紫欣公寓1栋406 

Primary sponsor's address:

Room 406, Building1, Zixin Apartment, 23 Yangliuwan Road, Nanhu District, Jiaxing, Zhejiang, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

嘉兴

Country:

china

Province:

Zhejiang

City:

Jiaxing

单位(医院):

嘉兴学院附属医院

具体地址:

中环南路1882号

Institution
hospital:

Affiliated Hospital of Jiaxing University

Address:

1882 Zhonghuan Road South

经费或物资来源:

嘉兴市第一医院麻醉科 

Source(s) of funding:

Department of Anesthesiology, Jiaxing First Hospital 

研究疾病:

肺癌 

Target disease:

Lung cancer 

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:

探索性研究/预试验 

Study phase:

研究目的:

研究超声引导下菱形肋间神经阻滞联合前锯肌神经阻滞在胸科手术术后镇痛效果的评价。 

Objectives of Study:

To evaluate the analgesic effect of ultrasonic guided rhomboid intercostal nerve block combined with anterior serratus nerve block after thoracic surgery. 

药物成份或治疗方案详述:

常规患者禁食6 h、禁饮2 h。患者入手术室后常规监测RR、ECG、MAP、HR、SpO2,三方(手术医生、麻醉医生、巡回护士)核查患者信息,麻醉诱导前预充氧3min,麻醉诱导:静脉注射丙泊酚2 mg/kg,咪达唑仑注射液:0.05 mg/kg,顺苯磺酸阿曲库铵:0.15 mg/kg,舒芬太尼注射液:0.5μg/kg;3 min后放置气管导管。RIS组行菱形肌神经阻滞(0.5%罗哌卡因10ml)联合前锯肌神经阻滞(0.5%罗哌卡因20ml),C组不进行任何神经阻滞。 RISS组行菱形肌神经阻滞(0.5%罗哌卡因10ml):患者取侧卧位,同侧手臂穿过胸部内收,肩胛骨向外侧移动。在斜矢状面置于肩胛骨内侧缘的内侧,采用线阵超声探头(LOGIQe GE公司超声机;Deutschland GmbH & Co. KG, Solingen, GERMAN),频率为10mHZ,明确超声标志、斜方肌、菱形肌、肋间肌、胸膜和肺,以 1%利多卡因行局部浸润麻醉,在T5水平将阻滞针平面内入路法进入,边回抽边进针,神经阻滞穿刺针成像后进针至菱形肌和肋间外肌之间的筋膜间隙内,将0.5%罗哌卡因10ml注射到此间隙内。 RISS组行前锯肌神经阻滞(0.5%罗哌卡因20ml):患者取侧卧位,在腋中线水平,采用线阵超声探头(LOGIQe GE公司超声机;Deutschland GmbH & Co. KG, Solingen, GERMAN),频率为10mHZ,明确超声标志前锯肌、肋间肌、胸膜和肺,以 1%利多卡因行局部浸润麻醉,在T5水平将阻滞针平面内入路法进入,边回抽边进针,神经阻滞穿刺针成像后进针至前锯肌和肋间外肌之间的筋膜间隙内,将0.5%罗哌卡因20ml注射到此间隙内。 两组术中均行容量控制模式机械通气,通气参数设置:VT 8-10ml/,RR 10-12次/分控制,PETCO2在35-45 mmHg。静吸复合全身麻醉维持:丙泊酚50-150ug/(kg·min),瑞芬太尼0.1-1ug/(kg·mim),顺苯磺酸阿曲库铵单次间断推注3-5mg,术中根据BIS值调整麻醉深度。术中补液量按照4-2-1法则补液,尽量维持循环稳定并在正常范围。 

Description for medicine or protocol of treatment in detail:

Conventional patients fasted for 6 h and drank for 2 h.Patients into the operating room after routine surveillance RR, ECG, MAP, HR, SpO2, three parties (the surgeon, anesthesiologist, nurse tour) check patient information, beforehand oxygenation 3 min before anesthesia induction, anesthesia induction: 2 mg/kg intravenous propofol, midazolam injection: 0.05 mg/kg, shun benzene sulfonic acid atracurium: 0.15 mg/kg, sufentanil injection: 0.5 mu g/kg;Tracheal catheter was placed 3 min later.RIS group received rhomboid muscle block (0.5% ropivacaine 10ml) combined with anterior serratus nerve block (0.5% ropivacaine 20ml), while C group did not receive any nerve block. Rhomboid muscle block (0.5% ropivacaine 10ml) was performed in the RISS group: the patient was placed in a lateral position, with the ipsilateral arm passing through the chest addention and the shoulder blades moving laterally.A linear array ultrasonic probe was placed on the oblique sagittal plane inside the medial edge of the scapula (LOGIQe GE ultrasonic machine;Deutschland GmbH & Co. KG, Solingen, GERMAN), frequency of 10 MHZ, clear indications of ultrasonic, trapezius muscle, diamond, intercostals muscles, the pleura and lungs, with 1% lidocaine local infiltration anesthesia, in T5 levels will block needle into plane approach, while withdrawing into needle, nerve block last in needle puncture needle imaging to rhomboid muscle and fascia space between the outside intercostals muscles, took 0.5% pp paid 10 ml injected into the gap. In the RISS group, serratus nerve block (0.5% ropivacaine 20ml) was performed: the patients were placed in lateral lying position at midaxillary line level, and a linear array ultrasonic probe was used (LOGIQe GE ultrasound machine;Deutschland GmbH & Co. KG, Solingen, GERMAN), frequency of 10 MHZ, saws, intercostals muscles before clear indications of ultrasonic, the pleura and lungs, with 1% lidocaine local infiltration anesthesia, in T5 levels will block needle into plane approach, while withdrawing into needle, nerve block saw before last in needle puncture needle imaging to muscle and fascia space between the outside intercostals muscles, took 0.5% pp paid within 20 ml injected into the gap. During the operation, both groups received volume-controlled mechanical ventilation. Ventilation parameters were set as follows: VT 8-10ml/ min, RR 10-12 times/min control, and PETCO2 was within 35-45 mmHg.Inhalation combined general anesthesia was maintained: propofol 50-150ug/(kg·min), Remifentanil 0.1-1ug/(kg· MIm), atracurium cisphenylsulfonic acid single intermittent injection 3-5mg, and the anesthesia depth was adjusted according to BIS value during the operation.The amount of intraoperative fluid should be supplemented according to the 4-2-1 rule to keep the circulation stable and within the normal range as far as possible. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.2020年9月至2022年9月于嘉兴市第一医院行单侧胸腔镜肺叶切手术,患者60例; 2.年龄18~80岁,ASA Ⅰ~Ⅲ级。 

Inclusion criteria

1. From September 2020 to September 2022, 60 patients underwent unilateral thoracoscopic lobectomy in Jiaxing first hospital; 2. Patients aged 18-80 years, ASA I - III. 

排除标准:

(1)休克或昏迷状态; (2) 心、肺、肝、肾及凝血功能异常; (3) 拟行阻滞区域感染,阻滞侧肢体严重神经损伤; (4) 有慢性疼痛服用镇痛药物史、服用精神病物病史、放化疗病史,对非甾体类抗炎药物有禁忌症的患者; (5) 对局麻药如利多卡因、罗哌卡因以及全身麻醉药物过敏患者; (6)患者及家属拒绝手术麻醉。 

Exclusion criteria:

1. Patients in shock or coma; 2. Patients with abnormal heart, lung, liver, kidney and coagulation function; 3. In patients with infection in the block area, severe nerve injury occurred in the limb of the block side; 4. Patients with chronic pain, history of taking analgesics, psychosis, radiotherapy and chemotherapy, and contraindications to non steroidal anti-inflammatory drugs; 5. Patients allergic to local anesthetics such as lidocaine, ropivacaine and general anesthetics; 6. Patients and their family members refused anesthesia. 

研究实施时间:

Study execute time:

From2020-09-17To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-09-17To 2021-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

菱形肋间神经阻滞组

样本量:

30

Group:

Rhombic intercostal nerve block

Sample size:

干预措施:

罗哌卡因20ml

干预措施代码:

Intervention:

Ropivacaine 20ml

Intervention code:

组别:

菱形肋间联合前锯肌神经阻滞组

样本量:

30

Group:

Rhombic intercostal nerve block combined with Anterior serratus nerve block

Sample size:

干预措施:

罗哌卡因40ml

干预措施代码:

Intervention:

Ropivacaine 40ml

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

嘉兴 

Country:

China 

Province:

Zhejiang 

City:

Jiaxing 

单位(医院):

嘉兴学院附属医院 

单位级别:

三甲 

Institution
hospital:

Affiliated Hospital of Jiaxing University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

NRS评分

指标类型:

主要指标 

Outcome:

NRS score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阿片类药物用量

指标类型:

主要指标 

Outcome:

Opioid use

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恶心呕吐

指标类型:

次要指标 

Outcome:

Nausea and vomiting

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第一次疼痛时间

指标类型:

次要指标 

Outcome:

Time of first pain

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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 80 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):

计算机随机数字法

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

Computer random number method

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

采用中国知网 https://www.cnki.net/

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

Adopt cnki https://www.cnki.net/

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:

嘉兴市第一医院伦理委员会保管,嘉兴市第一医院电子病历系统登记采集信息

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

The Ethics Committee of Jiaxing First Hospital shall keep it, and the electronic medical record system of Jiaxing First Hospital shall register and collect information

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-09-15
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