【ChiCTR-TRC-05000736】Analgesic Efficacy and Pharmacokinetic of Ropivacaine Continuous Wound Instillation Following Hepatic Resection

查看原文

立即下载

基本信息

登记号

ChiCTR-TRC-05000736

试验状态

暂停或中断

药物名称

药物类型

规范名称

首次公示信息日的期

2005-10-31

临床申请受理号

靶点

适应症

Pain control after elective liver resection surger

试验通俗题目

Analgesic Efficacy and Pharmacokinetic of Ropivacaine Continuous Wound Instillation Following Hepatic Resection

试验专业题目

Analgesic Efficacy and Pharmacokinetic of Ropivacaine Continuous Wound Instillation Following Hepatic Resection

申办单位信息

申请人联系人

请登录查看

申请人名称

请登录查看

联系人邮箱

请登录查看

联系人邮编

联系人通讯地址

请登录查看

临床试验信息

试验目的

Analgesic Efficacy and Pharmacokinetic of Ropivacaine Continuous Wound Instillation Following Hepatic Resection

试验分类

请登录查看

试验类型

随机平行对照

试验分期

其它

随机化

Random

盲法

试验项目经费来源

N/A

试验范围

目标入组人数

实际入组人数

第一例入组时间

2005-07-15

试验终止时间

2012-09-05

是否属于一致性

入选标准

To qualify for admission to this study, a patient must satisfy the criteria listed below: 1. The patient must be at least 18 years old and of legal age of consent; 2. If the patient is a female of childbearing potential: (1) she must has been using effective contraception and would continue to use effective contraception during the study period; (2) is not lactating and (3) must has a negative urine pregnancy test within 7 days prior to the surgery. 3. The patient is in satisfactory health as determined by the investigator on the basis of medical history and physical examination; 4. The patient is undergoing elective hepatic resection surgery and is expected to experience post-surgical pain in the absence of post-operative analgesia; 5. The patient has given written informed consent prior to undergoing any procedures for the study.；

排除标准

A patient will be excluded from this study if he/she meets any of the criteria listed below: 1. The patient is undergoing an emergency hepatic resection surgery; 2. The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness, which in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results; 3. The patient has any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures; 4. The patient's age is 70 or above; 5. The patient has a history of alcohol, analgesic or narcotic abuse; 6. The patient is unable to use PCA; 7. The patient has a known hypersensitivity to local anaesthetic drugs; 8. The patient is considered to have clinically significant intravascular volume-depletion in the opinion of the investigator; 9. The patient has history of opioid intolerance; 10. The patient has received any investigational medication within 30 days prior to administration of study medication or is scheduled to receive an investigational drug other than ropivacaine during the course of this study; 11. The patient develops major intra-operative complications, such as major haemorrhage or haemodynamic instability, which in the opinion of the investigator, would contraindicate study participation; 12. The patient has been admitted to this study previously.；

研究者信息

研究负责人姓名

请登录查看

试验机构

Department of Anaesthesia and Intensive Care, CUHK

研究负责人电话

请登录查看

研究负责人邮箱

请登录查看

研究负责人邮编

联系人通讯地址

请登录查看