今天是:2019-11-15 星期五

四肢骨折保守治疗后镇痛药物效果研究——一项随机对照双盲试验
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注册号:

Registration number:

ChiCTR1800017015 

最近更新日期:

Date of Last Refreshed on:

2019-06-16 

注册时间:

Date of Registration:

2018-07-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

四肢骨折保守治疗后镇痛药物效果研究——一项随机对照双盲试验 

Public title:

Pain management after nonoperative treatment of limb fracture - a double-blind randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

四肢骨折保守治疗后镇痛药物效果研究——一项随机对照双盲试验 

Scientific title:

Pain management after nonoperative treatment of limb fracture - a double-blind randomized controlled trial 

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:

郑宪友 

研究负责人:

郑宪友 

Applicant:

Xianyou Zheng 

Study leader:

Xianyou Zheng 

申请注册联系人电话:

Applicant telephone:

+86 13916180968 

研究负责人电话:

Study leader's telephone:

+86 13916180968 

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:

zhengxianyou@126.com 

研究负责人电子邮件:

Study leader's E-mail:

zhengxianyou@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:

中国上海市徐汇区宜山路600号 

研究负责人通讯地址:

中国上海市徐汇区宜山路600号 

Applicant address:

600 Yishan Road, Xuhui District, Shanghai, China 

Study leader's address:

600 Yishan Road, Xuhui District, Shanghai, 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:

上海交通大学附属第六人民医院 

Applicant's institution:

Shanghai Jiaotong University Affiliated Sixth People's Hospital 

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:

2018-024(2) 

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:

上海交通大学附属第六人民医院伦理委员会 

Name of the ethic committee:

Shanghai Jiaotong University Affiliated Sixth People 's Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-06-08 

伦理委员会联系人:

孙秀秀 

Contact Name of the ethic committee:

Xiuxiu Sun 

伦理委员会联系地址:

中国上海市徐汇区宜山路600号 

Contact Address of the ethic committee:

600 Yishan Road, Xuhui District, Shanghai, 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:

上海交通大学附属第六人民医院 

Primary sponsor:

Shanghai Jiaotong University Affiliated Sixth People's Hospital 

研究实施负责(组长)单位地址:

中国上海市徐汇区宜山路600号 

Primary sponsor's address:

600 Yishan Road, Xuhui District, Shanghai, 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):

上海

市(区县):

徐汇

Country:

China

Province:

Shanghai

City:

Xuhui

单位(医院):

上海交通大学附属第六人民医院

具体地址:

中国上海市徐汇区宜山路600号

Institution
hospital:

Shanghai Jiaotong University Affiliated Sixth People's Hospital

Address:

600 Yishan Road, Xuhui District, Shanghai, China

经费或物资来源:

上海交通大学医学院高峰高原计划—“研究型医师”基金 

Source(s) of funding:

Shanghai Jiaotong University School of Medicine peak plateau plan -  

研究疾病:

四肢骨折 

Target disease:

limb fracture 

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:

本研究的目的是确定骨折保守治疗患者单独应用对乙酰氨基酚是否不差于应用对乙酰氨基酚/羟考酮复合制剂的镇痛效果。本研究的更大目标是为该类患者提供安全有效的镇痛计划。 

Objectives of Study:

The aim of this study will be to determine whether acetaminophen alone is comparable to acetaminophen/oxycodone in pain relief after nonoperative treatment of limb fractures. The larger aim is to provide a safe and effective analgesic plan for such patients. 

药物成份或治疗方案详述:

受试者被随机分配至试验组或对照组。干预组将接受含有羟考酮(5mg)/对乙酰氨基酚(325mg)的口服药片(泰勒宁),对照组将接受仅含对乙酰氨基酚(650mg)的药片(泰诺林)。所有受试者被指导按需要服用他们指定的处方药,并且不超过每4小时一次。 

Description for medicine or protocol of treatment in detail:

Participants will be randomly allocated into the intervention group or control group. The intervention group will receive oral pills containing oxycodone (5 mg)/acetaminophen (325 mg), and the control group will receive pills containing acetaminophen (650 mg) only. All participants will be instructed to take their assigned prescription medication on a per need basis, and no more frequently than every 4 hours. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

年龄18-100周岁,性别不限;少于一天的急性四肢骨折;骨折部位包括足、踝、胫骨、腓骨、膝、股骨、髋、手、腕、前臂、肘、肱骨、肩与锁骨。有保守治疗的指征;有意愿参加本试验。 

Inclusion criteria

Aged from 18 to 100 years old, male or female is not limited; diagnosis of acute limb fracture less than one day after injury; location of fractures including foot, ankle, tibia, fibula, knee, femur, hip, hand, wrist, forearm, elbow, humerus, shoulder and clavicle; indicated for nonoperative treatment; and willing to participated in this study. 

排除标准:

合并其他非四肢骨折者;多部位多发骨折者;合并血管、神经及肌腱损伤者;开放性骨折者;需要频繁疼痛管理的慢性病者,如镰状细胞病,纤维肌痛或任何神经性疼痛等;曾使用过美沙酮者;对研究药物产生过不良反应者;对研究药物过敏或禁忌症者,如消化性溃疡;曾使用过娱乐性麻醉品者;可能影响阿片类药物、对乙酰氨基酚代谢的医疗状态者,如肝炎,肾功能不全或衰竭,甲状腺功能低下或亢进症,艾迪生氏病或库欣病;正服用任何可能与研究药物相互作用者,例如抗胆碱能药、口服避孕药、髓袢利尿剂、丙磺舒或肝酶诱导剂;精神疾病史、无法正常交流及回答问题者,例如痴呆等;肢体残疾行动不便者;无固定地址易失访者;血或尿HCG检测显示怀孕者;不愿意或无法配合资料收集者; 

Exclusion criteria:

With other non-limb fractures; multiple fractures involved more than one site; with vascular, nerve or tendon injuries; open fractures; chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy; have taken methadone ever; report of an adverse reaction to any of the study medications; allergic to any of the study medications or contraindications such as peptic ulcer disease; report of any prior use of recreational narcotics; medical condition that might affect metabolism of opioid analgesics, acetaminophen, such as hepatitis, renal insufficiency or failure, hypo- or hyperthyroidism, Addisons or Cushings disease; taking any medicine that might interact with any of the study medications, such as anticholinergic drugs, oral contraceptives, loop diuretic, probenecid or liver enzyme inducer; history of mental disorders, unable to communicate properly and answer questions such as dementia etc; physically handicapped people with mobility problems; no fixed address and easily lost to visitors; pregnancy by either urine or serum HCG testing; unwilling or unable to cooperate with data collectors. 

研究实施时间:

Study execute time:

From2018-07-02To 2020-07-02 

干预措施:

Interventions:

组别:

试验组

样本量:

500

Group:

intervention group

Sample size:

干预措施:

服用泰勒宁(羟考酮5mg+对乙酰氨基酚325mg)

干预措施代码:

Intervention:

receive oral pills containing oxycodone (5 mg)/acetaminophen (325 mg)

Intervention code:

组别:

对照组

样本量:

500

Group:

control group

Sample size:

干预措施:

服用泰诺林(对乙酰氨基酚650mg)

干预措施代码:

Intervention:

receive oral pills containing acetaminophen (650 mg) only

Intervention code:

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):

徐汇 

Country:

China 

Province:

Shanghai 

City:

Xuhui 

单位(医院):

上海交通大学附属第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Jiaotong University Affiliated Sixth People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

NRS评分

指标类型:

主要指标 

Outcome:

NRS score

Type:

Primary indicator 

测量时间点:

随机入组后第0、1、3、7、14天

测量方法:

Measure time point of outcome:

at 0, 1, 3, 7, and 14 days after randomization

Measure method:

指标中文名:

焦虑自评量表评分

指标类型:

次要指标 

Outcome:

SAS score

Type:

Secondary indicator 

测量时间点:

随机入组后第0、14天

测量方法:

Measure time point of outcome:

at 0 and 14 days after randomization

Measure method:

指标中文名:

抑郁自评量表评分

指标类型:

次要指标 

Outcome:

SDS score

Type:

Secondary indicator 

测量时间点:

随机入组后第0、14天

测量方法:

Measure time point of outcome:

at 0 and 14 days after randomization

Measure method:

指标中文名:

EQ-5d生活质量量表

指标类型:

次要指标 

Outcome:

EQ-5d

Type:

Secondary indicator 

测量时间点:

随机入组后第0、14天

测量方法:

Measure time point of outcome:

at 0 and 14 days after randomization

Measure method:

指标中文名:

对镇痛的满意度(0-10)

指标类型:

次要指标 

Outcome:

the patient’s satisfaction with the medication (0-10)

Type:

Secondary indicator 

测量时间点:

随机入组后第0、14天

测量方法:

Measure time point of outcome:

at 0 and 14 days after randomization

Measure method:

指标中文名:

睡眠情况变化

指标类型:

次要指标 

Outcome:

change in the quality and duration of sleep

Type:

Secondary indicator 

测量时间点:

随机入组后第0、14天

测量方法:

受试者本人记录夜间睡眠日记

Measure time point of outcome:

at 0 and 14 days after randomization

Measure method:

A nighttime sleeping diary will be recorded by the participants.

指标中文名:

服用研究药物的数量

指标类型:

次要指标 

Outcome:

number of study medications used

Type:

Secondary indicator 

测量时间点:

随机入组后第14天

测量方法:

Measure time point of outcome:

at 14 days after randomization

Measure method:

指标中文名:

服用研究药物的持续时间

指标类型:

次要指标 

Outcome:

duration that analgesics were taken

Type:

Secondary indicator 

测量时间点:

随机入组后第14天

测量方法:

受试者自述

Measure time point of outcome:

at 14 days after randomization

Measure method:

participant-report

指标中文名:

不良事件

指标类型:

次要指标 

Outcome:

adverse events

Type:

Secondary indicator 

测量时间点:

整个试验期间

测量方法:

Measure time point of outcome:

throughout the trial

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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 18 years
最大 Max age 100 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):

应用分层随机化的方法将受试者随机分配。将骨折部位作为分层因素:(1)足,踝,胫骨或腓骨;(2)膝,股骨或髋部;(3)手;(4)手腕或前臂;(5)肘或肱骨;(6)肩部或锁骨。随机化将由一名独立的研究助理进行,他不参与后续的受试者入组、干预、评估或数据分析等工作。通过SAS?V.9.4软件为每组(共6组)生成一千个不同的八位数随机数排列成的随机序列。

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

Stratified blocked randomization will be used to group the participants randomly. The fracture site will be a stratification factor, with the following blocks: (1) foot, ankle, tibia, or fibula; (2) knee, femur, or hip; (3) hand; (4) wrist or forearm; (5) elbow or humerus; (6) shoulder or clavicle. The

盲法:

本临床试验采用双盲的方法,即受试者及研究者皆不知受试者被分配至A组(干预组)还是B组(对照组),采用药物模拟技术完成。每个研究药物包装包含一个药瓶,并且每个药瓶含有20片泰勒宁或泰诺林(根据盲底设置)。药物将被相同的无标记的不透明明胶胶囊包裹,并充以少量的乳糖以平衡胶囊的重量。外包装和药瓶的形状完全相同,将随机数序列附于外包装。

Blinding:

This study will be a double-blind trial, in which neither the subjects nor the investigators knew whether the subjects were assigned to either group A (intervention group) or group B (control group). A single dummy technique will be used. Each study drug package contains one bottle, and each bottle contains 20 tablets of either oxycodone/acetaminophen or acetaminophen tablets (according to the blinding code). The drugs will be contained within identical unmarked, opaque gel capsules. The capsules will be topped up with small quantities of lactose to equalize the weight of the capsules. The shape of the outer packaging and the bottle is exactly the same. A random number sequence will be attached to the outer packet.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

在临床试验中获得的原始数据将在试验结束后6个月通过网站(http://www.medresman.org)公开。

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

The raw data obtained in this clinical trial will be disseminated to patients and the public via the Research Manager website (http://www.medresman.org) 6 months after the end of the trial.

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:

病例报告表由试验协调员与试验管理小组一起设计。所有电子患者身份信息将在一个安全的,受密码保护的数据库上进行,只能由基本人员访问。 具有患者识别信息的纸张形式将在上海交通大学医学院限制区内的安全锁定的文件柜中进行。患者只能由代码号识别。 直接访问源数据/文件将需要与试用有关的监控。所有纸张和电子数据将在试验完成后至少保留五年。

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

The case report form was designed by the test coordinator and the trial management team. All electronic patient identity information will be on a secure, password-protected database that can only be accessed by basic personnel. The form of paper with patient identification information will be carried out in a securely locked file cabinet in the restricted area of Shanghai Jiaotong University School of Medicine. Patients can only be identified by the code number. Direct access to source data/files will require trial-related monitoring. All paper and electronic data will be retained for at least five years after the test is completed.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-07-09
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