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Single shot versus continuous saphenous nerve block for postoperative pain management after total knee replacement: a randomised, double-blind trial
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注册号：

Registration number：

 ChiCTR-IIR-17011735 

最近更新日期：

Date of Last Refreshed on：

 2017-06-22 10:01:51 

注册时间：

Date of Registration：

 2017-06-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Single shot versus continuous saphenous nerve block for postoperative pain management after total knee replacement: a randomised, double-blind trial

Public title：

Single shot versus continuous saphenous nerve block for postoperative pain management after total knee replacement: a randomised, double-blind trial

注册题目简写：

English Acronym：

Saphenous nerve block for postop pain after total knee replacement

研究课题的正式科学名称：

Single shot versus continuous saphenous nerve block for postoperative pain management after total knee replacement: a randomised, double-blind trial

Scientific title：

Single shot versus continuous saphenous nerve block for postoperative pain management after total knee replacement: a randomised, double-blind 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：

Chan Chin Chin 

研究负责人：

Chan Chin Chin 

Applicant：

Chan Chin Chin 

Study leader：

Chan Chin Chin 

申请注册联系人电话：

Applicant telephone：

 95143667

研究负责人电话：

Study leader's
telephone：

95143667

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：

 chinchancc@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 chinchancc@gmail.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：

5/F, Operating Theatre, Main Block, Tuen Mun Hospital 23 Tsing Chung Koon Road, Tuen Mun, Hong Kong

研究负责人通讯地址：

5/F, Operating Theatre, Main Block, Tuen Mun Hospital 23 Tsing Chung Koon Road, Tuen Mun, Hong Kong

Applicant address：

5/F, Operating Theatre, Main Block, Tuen Mun Hospital 23 Tsing Chung Koon Road, Tuen Mun, Hong Kong

Study leader's address：

5/F, Operating Theatre, Main Block, Tuen Mun Hospital 23 Tsing Chung Koon Road, Tuen Mun, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

 852

研究负责人邮政编码：

Study leader's postcode：

 852

申请人所在单位：

Department of Anaesthesia and Intensive Care, Pok Oi Hospital

Applicant's institution：

Department of Anaesthesia and Intensive Care, Pok Oi Hospital

研究负责人所在单位：

Department of Anaesthesia and Intensive Care, Pok Oi Hospital

Affiliation of the Leader：

Department of Anaesthesia and Intensive Care, Pok Oi 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：

 NTWC/CREC/16081

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：

New Territories West Cluster Clinical & Research Ethics Committee

Name of the ethic committee：

New Territories West Cluster Clinical & Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-02-23 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

Department of Anaesthesia and Intensive Care, Pok Oi Hospital

Primary sponsor：

Department of Anaesthesia and Intensive Care, Pok Oi Hospital

研究实施负责（组长）单位地址：

Au Tau, Yuen Long, Hong Kong

Primary sponsor's address：

Au Tau, Yuen Long, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Departmental funding

Source(s) of funding：

Departmental funding

研究疾病：

Primary osteoarthritis of knee undergoing total knee replacement  

Target disease：

Primary osteoarthritis of knee undergoing total knee replacement

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：

 IV期临床试验 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To investigate and compare the effect of single shot versus continuous saphenous nerve blockade on pain control in the early postoperative period for patients undergoing unilateral primary total knee replacement.  

Objectives of Study：

To investigate and compare the effect of single shot versus continuous saphenous nerve blockade on pain control in the early postoperative period for patients undergoing unilateral primary total knee replacement.

药物成份或治疗方案详述：

Total of 60 patients with primary osteoarthritis of knee undergoing unilateral primary total knee replacement will be recruited. They will be randomised into 2 groups: single shot (n = 30) and continuous saphenous nerve block group (n = 30). Both groups will receive a bolus of 4 - 6ml 1% ropivacaine injected via the saphenous nerve catheter immediately after total knee replacement. Single shot group will then receive placebo (4 - 6ml 0.9% normal saline) while continuous nerve block group will receive 4 - 6 ml of 1% ropivacaine, injected via the saphenous nerve catheter every 6 hours regularly and 15 min before physiotherapy sessions twice daily, for post-op 2- 3 days. They will be assessed regularly for postop pain score, opioid usage and side effects.  

Description for medicine or protocol of treatment in detail：

Total of 60 patients with primary osteoarthritis of knee undergoing unilateral primary total knee replacement will be recruited. They will be randomised into 2 groups: single shot (n = 30) and continuous saphenous nerve block group (n = 30). Both groups will receive a bolus of 4 - 6ml 1% ropivacaine injected via the saphenous nerve catheter immediately after total knee replacement. Single shot group will then receive placebo (4 - 6ml 0.9% normal saline) while continuous nerve block group will receive 4 - 6 ml of 1% ropivacaine, injected via the saphenous nerve catheter every 6 hours regularly and 15 min before physiotherapy sessions twice daily, for post-op 2- 3 days. They will be assessed regularly for postop pain score, opioid usage and side effects.  

纳入标准：

Inclusion criteria

排除标准：

1. Patients with secondary osteoarthritis of the knee;
2. Patients undergoing operation under general anaesthesia;
3. Pregnancy;
4. Body weight < 45 kg or body mass index > 40 kg/m2;
5. Allergy to opioid or local anaesthetics;
6. Patients with contraindications to COX-2 inhibitors use;
7. Chronic opioid use (> 1 month of 60mg morphine oral equivalents daily);
8. Subject refusal.

Exclusion criteria：

1. Patients with secondary osteoarthritis of the knee;
2. Patients undergoing operation under general anaesthesia;
3. Pregnancy;
4. Body weight < 45 kg or body mass index > 40 kg/m2;
5. Allergy to opioid or local anaesthetics;
6. Patients with contraindications to COX-2 inhibitors use;
7. Chronic opioid use (> 1 month of 60mg morphine oral equivalents daily);
8. Subject refusal.

研究实施时间：

Study execute time：

从 From 2017-10-01 00:00:00至 To 2018-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-10-01 00:00:00 至 To 2018-06-30 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 30

Group：

Group 1

Sample size：

干预措施：

Single shot saphenous nerve block

干预措施代码：

Intervention：

Single shot saphenous nerve block

Intervention code：

组别：

Group 2

样本量：

 30

Group：

Group 2

Sample size：

干预措施：

Continuous saphenous nerve block

干预措施代码：

Intervention：

Continuous saphenous nerve block

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Pok Oi Hospital 

单位级别：

 Public hospital under Hospital Authority 

Institution
hospital：

Pok Oi Hospital

Level of the institution：

Public hospital under Hospital Authority

测量指标：

Outcomes：

指标中文名：

Pain score at rest, active flexion and during physiotherapy session on postop day 1, day 2 and day 3

指标类型：

主要指标

Outcome：

Pain score at rest, active flexion and during physiotherapy session on postop day 1, day 2 and day 3

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Cumulative fentanyl consumption on postop day 1, day 2 and day 3

指标类型：

主要指标

Outcome：

Cumulative fentanyl consumption on postop day 1, day 2 and day 3

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Cumulative tramadol consumption on postop day 1, day 2 and day 3

指标类型：

主要指标

Outcome：

Cumulative tramadol consumption on postop day 1, day 2 and day 3

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Incidence of nausea and vomiting

指标类型：

次要指标

Outcome：

Incidence of nausea and vomiting

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Patient satisfaction

指标类型：

次要指标

Outcome：

Patient satisfaction

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Other adverse events such as nerve injury, vascular injury, infection at catheter site, fall

指标类型：

次要指标

Outcome：

Other adverse events such as nerve injury, vascular injury, infection at catheter site, fall

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Personal data

Tissue：

Age, gender, height, weight, ASA physical status, HN number

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

Upon completion of the study, all personal data will be erased according to the Hospital Authority's Data Protection Policy and Practice.

标本中文名：

组织：

Sample Name：

Clinical outcome

Tissue：

Pain score, opioid usage, patient satisfaction, adverse effects

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 79 岁 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）：

Randomization will be performed by computer program and the results will be sealed in concealed envelops.

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

Randomization will be performed by computer program and the results will be sealed in concealed envelops.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

否No

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）：

Anonymised IPD will be shared on a case-by-case basis upon request.

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

Anonymised IPD will be shared on a case-by-case basis upon request.

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：

Anonymised IPD will be shared on a case-by-case basis upon request, with approval by the Hospital Authority.

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

Anonymised IPD will be shared on a case-by-case basis upon request, with approval by the Hospital Authority.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2017-06-22 10:01:51
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