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Application of electroacupuncture combined with erector spinae plane block in anesthesia of non tracheal intubation thoracoscopic surgery

注册号：

Registration number：

ITMCTR2000003773

最近更新日期：

Date of Last Refreshed on：

2020-08-27

注册时间：

Date of Registration：

2020-08-27

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

电针联合竖脊肌平面阻滞在非气管插管胸腔镜手术麻醉中的应用

Public title：

Application of electroacupuncture combined with erector spinae plane block in anesthesia of non tracheal intubation thoracoscopic surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

电针联合竖脊肌平面阻滞在非气管插管胸腔镜手术麻醉中的应用

Scientific title：

Application of electroacupuncture combined with erector spinae plane block in anesthesia of non tracheal intubation thoracoscopic surgery

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

2019YYQ13

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：

ChiCTR2000037222 ; ChiMCTR2000003773

申请注册联系人：

施海峰

研究负责人：

施海峰

Applicant：

Haifeng Shi

Study leader：

Haifeng Shi

申请注册联系人电话：

Applicant telephone：

+86 18721752280

研究负责人电话：

Study leader's telephone：

+86 18721752280

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：

215756265@qq.com

研究负责人电子邮件：

Study leader's E-mail：

215756265@qq.com

申请单位网址(自愿提供)：

Study leader's 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：

上海市虹口区甘河路110号3号楼8楼

研究负责人通讯地址：

上海市虹口区甘河路110号3号楼8楼

Applicant address：

8th Floor, Building 3, 110 Ganhe Road, Hongkou District, Shanghai

Study leader's address：

8th Floor, Building 3, 110 Ganhe Road, Hongkou District, Shanghai

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：

上海中医药大学附属岳阳中西医结合医院

Applicant's institution：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2020-033

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2020/6/23 0:00:00

伦理委员会联系人：

殷从全

Contact Name of the ethic committee：

Congquan Yin

伦理委员会联系地址：

上海市虹口区甘河路110号8号楼1楼

Contact Address of the ethic committee：

8th Floor, Building 3, 110 Ganhe Road, Hongkou District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 65161782-8122

伦理委员会联系人邮箱：

Contact email of the ethic committee：

yyyyllwyh@163.com

研究实施负责（组长）单位：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Medicine

研究实施负责（组长）单位地址：

上海市虹口区甘河路110号3号楼8楼

Primary sponsor's address：

8th Floor, Building 3, 110 Ganhe Road, Hongkou District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

具体地址：

虹口区甘河路110号

Institution
hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Medicine

Address：

110 Ganhe Road, Hongkou District

经费或物资来源：

岳阳医院院内基金孵育项目

Source(s) of funding：

Funding for scientific research projects in Yueyang Hospital（2019YYQ13）

研究疾病：

胸腔镜肺叶切除手术

研究疾病代码：

Target disease：

Thoracoscopic lobectomy

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

本研究目的在于将针刺麻醉与竖脊肌平面阻滞技术相结合，为胸腔镜手术的麻醉方式提供了新的方法和思路。一方面针刺麻醉镇静、稳定循环、器官保护的作用减少了术中静脉辅助用药的量，另一方面竖脊肌平面阻滞弥补了针刺麻醉的镇痛不足，两者的结合期望为胸腔镜手术麻醉探索出一项可行、安全、医患均体验良好且能加快患者康复的麻醉技术，并为该技术的广泛推广提供理论依据和实践方案。

Objectives of Study：

The purpose of this study is to combine acupuncture anesthesia with erector spinalis plane block technology, and provide a new method and idea for the anesthesia of thoracoscopic surgery. On the one hand, acupuncture anesthesia sedation, stable circulation, organ protection reduce the amount of intravenous adjuvant drugs, on the other hand, erector spinalis plane block makes up for the lack of acupuncture anesthesia analgesia, the combination of the two is expected to explore a feasible, safe, good experience for both doctors and patients, and can accelerate the recovery of patients, and promote the technology widely Provide theoretical basis and practical plan.

药物成份或治疗方案详述：

由于竖脊肌平面阻滞是一项新型的神经阻滞技术，其局麻药用量尚无统一方案，为了保证竖脊肌平面阻滞应用于胸腔镜手术镇痛的有效性，本研究将分为两部分进行。第一部分主要通过序贯法来测定竖脊肌平面阻滞用于胸腔镜手术镇痛时0.5%罗哌卡因容量的ED95，第二部分试验在第一部分试验的基础上，采用第一部分试验得出的局麻药使用推荐量进行竖脊肌平面阻滞，从而保证竖脊肌平面阻滞的有效性，为第二部分无气管插管麻醉方法试验的顺利进行提供基础。 1.竖脊肌平面阻滞用于胸腔镜手术镇痛时0.5%罗哌卡因容量的ED95。 术前使用不同容量的0.5%罗哌卡因对患者进行T6节段的竖脊肌平面阻滞，首例患者用药量为35ml ,此容量为预实验中证明阻滞有效的一个较大的容量值。由于竖脊肌平面阻滞起效较慢，临床观察需要30-60分钟，而临床工作繁忙且节奏较快，且测试阻滞平面靠患者主观感觉，存在较大误差，所以本研究以手术开始切皮时生命体征无明显波动，术后患者苏醒拔管时无躁动，术后2小时未使用补救性镇痛药物时患者VAS评分≤3分来判断竖脊肌平面阻滞有效或者无效。按照 DIXON的上下序贯法，第一例患者若有效，第二例患者的局麻药容量下降一个阶梯即减少2ml，相反若无效，第二例患者需增加2ml容量，以此类推，直至出现7个无效容量的拐点，然后根据probit概率回归法计算容量的ED95及95%可信区间（CI）。 2.比较无气管插管电针联合竖脊肌平面阻滞清醒镇静的麻醉方法与单纯竖脊肌平面阻滞复合静脉镇静镇痛的麻醉方法，明确电针能够减少静脉镇静镇痛药物的使用，电针能够使循环更加稳定。 通过两种麻醉方法术中静脉镇静镇痛药物的使用量，术中生命体征的变化，术中外科医师的操作体验、患者的舒适度、术后恢复质量等进行评估，同时检测多项与手术应激及预后相关的分子生物学指标，如：血浆皮质醇、血浆的痛介质β-内啡肽、5-羟色胺、炎症介质IL-6、TNF-?等，证实无气管插管电针联合竖脊肌平面阻滞清醒镇静的麻醉方法安全可行且可以加速患者康复。

Description for medicine or protocol of treatment in detail：

As the erector spinalis plane block is a new type of nerve block technology, there is no unified plan for its local anesthetic dosage. In order to ensure the effectiveness of spinal plane block in thoracoscopic surgery analgesia, this study will be divided into two parts. In the first part, ED95 of 0.5% ropivacaine volume was determined by sequential method. In the second part, on the basis of the first part of the experiment, the recommended amount of local anesthetics obtained from the first part of the experiment was used to carry out the erector spinalis plane block, so as to ensure the effectiveness of the erector spinalis plane block, which is the second part of anesthesia without tracheal intubation The test of drunk method provides the basis for the smooth progress of the test. 1. ED95 of 0.5% ropivacaine volume was used for analgesia in thoracoscopic surgery. Before operation, 0.5% ropivacaine with different volumes was used to block the erector spinalis at T6 segment. The dosage of ropivacaine in the first patient was 35ml, which was a larger volume value proved to be effective in the preliminary experiment. Because of the slow onset of erector spinalis plane block, clinical observation takes 30-60 minutes, while the clinical work is busy and the rhythm is fast, and the test of block plane depends on the subjective feeling of patients, there is a large error. Therefore, in this study, there is no significant fluctuation of vital signs at the beginning of skin incision, there is no agitation when patients wake up and extubate, and VAS score is not used 2 hours after surgery when no remedial analgesic drugs are used No more than 3 points were used to judge whether the erector spinalis plane block was effective or ineffective. According to Dixon's up-down sequential method, if the first patient is effective, the second patient's local anesthetic capacity will decrease by one step, that is, 2ml. On the contrary, if it is ineffective, the second patient needs to increase 2ml volume, and so on until there are seven inflection points of invalid volume. Then ED95 and 95% confidence interval (CI) of capacity are calculated according to probit probability regression method. 2. To compare the anesthesia method of conscious sedation by electroacupuncture combined with erector spinalis plane block without tracheal intubation and the anesthesia method of simple spinal muscle plane block combined with intravenous sedation and analgesia, it is clear that electroacupuncture can reduce the use of intravenous sedative and analgesic drugs, and electroacupuncture can make the circulation more stable. The usage of intravenous sedative and analgesic drugs, the changes of vital signs, the operating experience of surgeons, the comfort of patients, and the quality of postoperative recovery were evaluated. Meanwhile, a number of molecular biological indicators related to surgical stress and prognosis were detected, such as plasma cortisol, plasma pain mediators β - endorphin, 5-hydroxytryptamine and inflammatory mediators The results of IL-6, TNF - α and so on confirmed that the anesthesia method of conscious sedation without tracheal intubation combined with erector spinalis plane block is safe and feasible, and can accelerate the recovery of patients.

纳入标准：

1) ASA分级为Ⅰ-Ⅲ级； 2) 年龄18 -65周岁，性别不限； 3) 既往无免疫系统疾病者； 4) 签署知情同意书。

Inclusion criteria

1) The ASA grade was I - III; 2) Aged 18-65 years, no gender limit; 3) Patients without previous immune system diseases; 4) Sign informed consent.

排除标准：

研究一排除标准 1)近四周内参加过其它临床试验患者； 2)不能配合完成研究计划的病人，包括传染病及其它病史； 3)孕妇、产妇、尿妊娠试验阳性的患者； 4)术前合并疼痛，正在使用中枢性镇痛药物的患者，阿片类药物成瘾、依赖者； 5)术前合并严重的其它系统疾病及严重精神疾病； 6)肝肾功能异常（ALT、AST、BUN、Cr 超出正常值1.5倍）者； 7)BMI≥30kg/m2或体重小于50kg者； 8)器质性心脏病或心律失常者； 9)急诊手术或再次胸腔镜手术者； 10)脊柱畸形、凝血异常、竖脊肌平面阻滞穿刺部位感染。 研究二排除标准 1)经穴局部有皮肤感染的患者，有肢体神经损伤的患者； 2)近四周内参加过其它临床试验患者； 3)不能配合完成研究计划的病人，包括传染病及其它病史； 4)孕妇、产妇、尿妊娠试验阳性的患者； 5)术前合并疼痛，正在使用中枢性镇痛药物的患者，阿片类药物成瘾、依赖者； 6)术前合并严重的其它系统疾病及严重精神疾病； 7)肝肾功能异常（ALT、AST、BUN、Cr 超出正常值1.5倍）者； 8)BMI≥30kg/m2或体重小于50kg者； 9)器质性心脏病或心律失常者； 10)急诊手术或再次胸腔镜手术者； 11)脊柱畸形、凝血异常、竖脊肌平面阻滞穿刺部位感染。

Exclusion criteria：

Study one exclusion criteria 1) Patients who have participated in other clinical trials in the past four weeks; 2) Patients who could not cooperate to complete the study included infectious diseases and other medical history; 3) Patients with positive urine pregnancy test; 4) Patients with preoperative pain, using central analgesics, opioid addicts and addicts; 5) Severe other system diseases and serious mental diseases were found before operation; 6) Patients with abnormal liver and kidney function (ALT, AST, BUN, Cr exceeding 1.5 times of normal value); 7) BMI>=30kg/m2 or Weight less than 50kg; 8) Organic heart disease or arrhythmia; 9) Emergency surgery or video-assisted thoracoscopic surgery; 10) Spinal deformity, abnormal blood coagulation, and infection of puncture site of erector spinalis plane block. Study 2 exclusion criteria 1) Patients with skin infection at acupoints and limb nerve injury; 2) Patients who have participated in other clinical trials in the past four weeks; 3) Patients who could not cooperate to complete the study included infectious diseases and other medical history; 4) Patients with positive urine pregnancy test; 5) Patients with preoperative pain, using central analgesics, opioid addicts and addicts; 6) Severe other system diseases and serious mental diseases were found before operation; 7) Patients with abnormal liver and kidney function (ALT, AST, BUN, Cr exceeding 1.5 times of normal value); 8) BMI>=30kg/m2 or Weight less than 50kg; 9) Organic heart disease or arrhythmia; 10) Emergency surgery or video-assisted thoracoscopic surgery; 11) Spinal deformity, abnormal blood coagulation, and infection of puncture site of erector spinalis plane block.

研究实施时间：

Study execute time：

从From 2020-10-01

至To      2021-12-31

征募观察对象时间：

Recruiting time：

从From 2020-10-01

至To      2021-12-31

干预措施：

Interventions：

组别：

电针联合竖脊肌平面阻滞组

样本量：

20

Group：

Electroacupuncture combined with erector spinalis plane block group

Sample size：

干预措施：

电针刺激穴位联合竖脊肌平面阻滞

干预措施代码：

Intervention：

Electroacupuncture point stimulation combined with erector spinalis plane block group

Intervention code：

组别：

电针组

样本量：

20

Group：

Electroacupuncture group

Sample size：

干预措施：

电针刺激穴位

干预措施代码：

Intervention：

Acupoint stimulation by Electroacupuncture

Intervention code：

样本总量 Total sample size ： 40

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海

市(区县)：

虹口区

Country：

China

Province：

Shanghai

City：

Hongkou District

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

单位级别：

三级甲等

Institution/hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术中血气分析二氧化碳分压最高值

指标类型：

次要指标

Outcome：

The highest value of partial pressure of carbon dioxide in blood gas analysis during operation

Type：

Secondary indicator

测量时间点：

术中

测量方法：

动脉血气分析

Measure time point of outcome：

Intraoperative

Measure method：

Arterial blood gas analysis

指标中文名：

术中瑞芬太尼使用量

指标类型：

主要指标

Outcome：

Intraoperative remifentanil dosage

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术前术后血液指标血浆皮质醇、血浆的痛介质β-内啡肽、5-羟色胺、炎症介质IL-6、TNF-?等变化

指标类型：

次要指标

Outcome：

The changes of blood indexes such as plasma cortisol, pain mediators β - endorphin, 5-hydroxytryptamine, inflammatory mediators IL-6 and TNF - α before and after operation

Type：

Secondary indicator

测量时间点：

手术开始前及手术结束2小时后

测量方法：

Measure time point of outcome：

Before and 2 hours after the operation

Measure method：

指标中文名：

麻醉诱导后恢复自主呼吸的时间

指标类型：

次要指标

Outcome：

Time of spontaneous respiration recovery after anesthesia induction

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者苏醒拔出气管导管时有无躁动

指标类型：

主要指标

Outcome：

Does the patient have agitation when extubation tracheal tube

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

手术开始切皮时生命体征变化

指标类型：

主要指标

Outcome：

Changes of vital signs at the beginning of skin incision

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后2小时是否使用补救性镇痛药物以及VAS评分

指标类型：

主要指标

Outcome：

Whether or not to use remedial analgesics 2 hours after operation and VAS score

Type：

Primary indicator

测量时间点：

术后2小时

测量方法：

VAS评分

Measure time point of outcome：

2 hours after operation

Measure method：

VAS score

指标中文名：

术中瑞芬太尼使用量

指标类型：

次要指标

Outcome：

Intraoperative remifentanil dosage

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：

血液

组织：

Sample Name：

Blood

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：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

采用随机数字表法将纳入本试验的研究对象平均分为试验组和对照组。

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

The subjects were randomly divided into experimental group and control group.

盲法：

未说明

Blinding：

Not stated

是否共享原始数据：

IPD sharing：

是

Yes

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）：

试验完成6个月内将原始数据上传http://www.medresman.org.cn/login.aspx，ResMan临床试验公共管理平台

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

The original data will be uploaded to http://www.medresman.org.cn/login.aspx within 6 months after the completion of the test.

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：

及时填写CRF表，并上传于ResMan临床试验公共管理平台。

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

Fill in CRF form in time and upload it to Resman clinical trial public management platform.

数据管理委员会：

Data Managemen Committee：

无

No

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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