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

    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
    申请人名称
    联系人邮箱
    联系人邮编

    联系人通讯地址
    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
    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

    22

    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
    试验机构

    Department of Anaesthesia and Intensive Care, CUHK

    研究负责人电话
    研究负责人邮箱
    研究负责人邮编

    /

    联系人通讯地址

    Department of Anaesthesia and Intensive Care, CUHK的其他临床试验

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    Chinese University of Hong Kong的其他临床试验

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