今天是:2022-08-12 星期五

右美托咪定复合罗哌卡因腹横肌平面阻滞用于腹腔镜结肠癌根治术术后镇痛及恢复的效果观察
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注册号:

Registration number:

ChiCTR-IOR-17014122 

最近更新日期:

Date of Last Refreshed on:

2022-04-25 

注册时间:

Date of Registration:

2017-12-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

右美托咪定复合罗哌卡因腹横肌平面阻滞用于腹腔镜结肠癌根治术术后镇痛及恢复的效果观察 

Public title:

Dexmedetomidine Added to Ropivacaine in Ultrasound-guided Tranversus Abdominis Plane Block Improved Postoperative Analgesia and Recovery after Laparoscopic Radical Operation on Colon 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

右美托咪定复合罗哌卡因腹横肌平面阻滞用于腹腔镜结肠癌根治术术后镇痛及恢复的效果观察 

Scientific title:

Dexmedetomidine Added to Ropivacaine in Ultrasound-guided Tranversus Abdominis Plane Block Improved Postoperative Analgesia and Recovery after Laparoscopic Radical Operation on Colon 

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:

姜美如 

研究负责人:

马加海 

Applicant:

Jiang Meiru 

Study leader:

Ma Jiahai 

申请注册联系人电话:

Applicant telephone:

+86 13964577623 

研究负责人电话:

Study leader's telephone:

+86 13656456186 

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:

ruruqing@vip.qq.com 

研究负责人电子邮件:

Study leader's E-mail:

mjh-214@126.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:

烟台市芝罘区毓璜顶东路20号 

研究负责人通讯地址:

烟台市芝罘区毓璜顶东路20号 

Applicant address:

20 Yuhuangding Road East, Zhifu District, Yantai, Shandong, China  

Study leader's address:

20 Yuhuangding Road East, Zhifu District, Yantai, Shandong, China  

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:

青岛大学医学院附属烟台毓璜顶医院 

Applicant's institution:

The Affiliated Yantai Yuhuangding Hospital of Qingdao Medical College 

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:

2016-197 

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:

烟台毓璜顶医院伦理委员会 

Name of the ethic committee:

Institutional Human Investigations Committee of Yantai Yuhuangding Hospital of Qingdao University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-12-30 

伦理委员会联系人:

高振利 

Contact Name of the ethic committee:

Gao Zhenli 

伦理委员会联系地址:

烟台市芝罘区毓璜顶东路20号 

Contact Address of the ethic committee:

20 Yuhuangding Road East, Zhifu District, Yantai, Shandong, China  

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:

青岛大学医学院附属烟台毓璜顶医院 

Primary sponsor:

The Affiliated Yantai Yuhuangding Hospital of Qingdao Medical College 

研究实施负责(组长)单位地址:

烟台市芝罘区毓璜顶东路20号 

Primary sponsor's address:

20 Yuhuangding Road East, Zhifu District, Yantai, Shandong, 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):

山东

市(区县):

烟台

Country:

China

Province:

Shandong

City:

Yantai

单位(医院):

青岛大学医学院附属烟台毓璜顶医院

具体地址:

芝罘区毓璜顶东路20号

Institution
hospital:

The Affiliated Yantai Yuhuangding Hospital of Qingdao Medical College

Address:

20 Yuhuangding Road East, Zhifu District

经费或物资来源:

无 

Source(s) of funding:

no 

研究疾病:

结肠癌 

Target disease:

colon 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:

其它 

Study phase:

N/A 

研究目的:

多模态镇痛技术结合局部麻醉技术和系统的镇痛药治疗可以更好的疼痛控制。作为一种多模态镇痛方案的重要组成部分,在腹部手术后,TAPB已被证明有效地提供镇痛。然而,单次注射TAP所提供的镇痛时间已被证明缩短了。迄今为止,包括地塞米松、克隆尼定、芬太尼、镁和咪达唑仑在内的各种佐剂已被用于延长不同程度的神经阻滞的持续时间。然而,佐剂对周围神经阻滞的影响是有争议的;先前的研究已经报告了积极和消极的影响。本试验的目的是评估在超声引导下的TAPB中添加右美托咪定对罗哌卡因是否能延长麻醉时间,并改善腹腔镜结肠癌根治术后恢复质量。 

Objectives of Study:

A multimodal analgesia technique combining of regional anesthetic techniques and systemic administration of analgesic agents results in better pain control. As important part of a multimodal analgesic regimen following abdominal surgery, TAPB has been shown to effectively provide analgesia. However, the duration of analgesia provided by a single-injection TAPB has been demonstrated to be shorter. So far, a variety of adjuvants, including dexamethasone, clonidine, fentanyl, magnesium, and midazolam, have been used to prolong the duration of analgesia of nerve blocks with varying degrees of success.However, the effects of adjuvants on peripheral nerve blocks are controversial; previous studies have reported both positive and negative effects. The aim of trial was to evaluate whether adding DEX to ropivacaine in ultrasound-guided TAPB may prolong the analgesic duration and improve recovery following laparoscopic radical operation on colon. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

70位ASA I-II 病人(年龄25-65岁,体重52-83公斤),择期行全麻下腹腔镜下结肠癌根治术。 

Inclusion criteria

70 ASA I-II patients (aged 25-65 years, weighted 52-83 kg) scheduled for laparoscopic radical operation on colon under general anaesthesia were registered. 

排除标准:

对本研究中药物有过敏史,心理障碍,神经阻滞部位感染;腹横机平面阻滞的其他禁忌症;对阿片类药物有耐受性(本研究前48小时内使用过阿片类药物)。 

Exclusion criteria:

Patients were excluded if they had a history of allergy to the drugs used in this study, psychological disorders, infection of the block injection site or any other contraindications for TAPB, tolerance to opioids or if they had used opioids within 48 h prior to the study. 

研究实施时间:

Study execute time:

From2017-02-12To 2018-08-31 

征募观察对象时间:

Recruiting time:

From2017-12-30To  

干预措施:

Interventions:

组别:

试验组

样本量:

35

Group:

study group

Sample size:

干预措施:

腹横机平面阻滞给予20ml 0.375% 罗哌卡因加入2ml右美托咪定(1ug/kg)

干预措施代码:

Intervention:

TAP with 20 mL of ropivacaine 0.375% plus 2mL of DEX (1μg/kg)

Intervention code:

组别:

对照组

样本量:

35

Group:

control group

Sample size:

干预措施:

腹横机平面阻滞给予20ml 0.375% 罗哌卡因加入2ml生理盐水

干预措施代码:

Intervention:

TAP with 20 mL of ropivacaine 0.375% plus 2mL normal saline

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

烟台 

Country:

China 

Province:

Shandong 

City:

Yantai 

单位(医院):

青岛大学医学院附属烟台毓璜顶医院 

单位级别:

三甲医院 

Institution
hospital:

The Affiliated Yantai Yuhuangding Hospital of Qingdao Medical College  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

静息VAS评分

指标类型:

主要指标 

Outcome:

resting VAS pain score

Type:

Primary indicator 

测量时间点:

术后2,4,12,24小时

测量方法:

Measure time point of outcome:

2, 4, 12, and 24 h postoperatively

Measure method:

指标中文名:

活动后VAS评分

指标类型:

主要指标 

Outcome:

VAS score after exercise

Type:

Primary indicator 

测量时间点:

术后2,4,12,24小时

测量方法:

Measure time point of outcome:

2, 4, 12, and 24 h postoperatively

Measure method:

指标中文名:

最高感觉阻滞平面

指标类型:

次要指标 

Outcome:

The highest level of sensory block

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总感觉阻滞时间

指标类型:

次要指标 

Outcome:

duration of sensory block

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

镇痛时间

指标类型:

次要指标 

Outcome:

the duration of analgesia

Type:

Secondary indicator 

测量时间点:

神经阻滞至第一次补救镇痛药物时间

测量方法:

Measure time point of outcome:

between the end of local anesthetic administration and first rescue analgesic administration.

Measure method:

指标中文名:

不良事件

指标类型:

副作用指标 

Outcome:

Adverse events

Type:

Adverse events 

测量时间点:

术后24小时

测量方法:

Measure time point of outcome:

during 24 h postoperative period

Measure method:

指标中文名:

镇静评分

指标类型:

次要指标 

Outcome:

sedation score

Type:

Secondary indicator 

测量时间点:

术后24小时

测量方法:

Measure time point of outcome:

during 24 h postoperative period

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 25 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):

由独立的麻醉助手根据随机数字表随机分组

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

Randomization by an independent anesthesia assistant based on randomized table.

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

通过resman提供原始数据查询

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

IPD will be public accessable via ResMan

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:

暂无。

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

no

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2017-12-24
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