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【ChiCTR2000028730】Randomized Comparison of Intrathecal Morphine Versus Standard Therapy on Post-Caesarean Delivery Quality of Recovery

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基本信息

登记号

ChiCTR2000028730

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2020-01-01

临床申请受理号

靶点

适应症

Parturients

试验通俗题目

Randomized Comparison of Intrathecal Morphine Versus Standard Therapy on Post-Caesarean Delivery Quality of Recovery

试验专业题目

Randomized Comparison of Intrathecal Morphine Versus Standard Therapy on Post-Caesarean Delivery Quality of Recovery

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

0000

联系人通讯地址

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临床试验信息

试验目的

To measure the quality of recovery in parturients receiving intrathecal morphine versus standard oral therapy after elective cesarean delivery.

试验分类

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试验类型

随机平行对照

试验分期

Ⅳ期

随机化

Intrathecal morphine and placebo groups will be numbered group 0 or 1 randomly with the assignment concealed in a sealed opaque envelope until after the final data analysis. After recruitment, patients will be randomly allocated into either groups in a 1:1 ratio using computer generated random number sequence.

盲法

None

试验项目经费来源

Departmental funding

试验范围

目标入组人数

实际入组人数

第一例入组时间

2020-02-03

试验终止时间

2022-12-30

是否属于一致性

入选标准

1. Elective cesarean delivery under single shot spinal anesthesia; 2. Lower segment cesarean delivery with planned Pfannestiel incision; 3. ASA (American Society of Anesthesiologists) Class 1 to 2; 4. Aged >=18 years old; 5. Willing and able to give consent.；

排除标准

1. Emergency cesarean delivery; 2. Indication for additional post-operative analgesics on top of usual departmental regime (e.g. classical cesarean, pre-eclampsia, post-partum hemorrhage); 3. Contraindicated to paracetamol or diclofenac (e.g. allergy, renal or liver impairment, asthma, peptic ulcer disease); 4. Allergic to morphine.；

研究者信息

研究负责人姓名

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试验机构

Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

0000

联系人通讯地址