Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00108

2 Trial Registration Date

2006-03-21

iRegistration Status

Retrospective

3 Secondary IDs

n/a

4 Source(s) of Funding

Department of Anaesthesiology and Operating Theatre Services, Kwong Wah Hospital, Kowloon, Hong Kong and Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong

5 Primary Sponsor

Department of Anaesthesiology and Operating Theatre Services, Kwong Wah Hospital, Kowloon, Hong Kong

6 Secondary Sponsor

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong

Function

Please specify

7Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ying Y LEE

ii Address

iii Phone

yylee@ha.org.hk

iv Email

email

v Affiliation

vi Country

8Research Contact Person (person to contact for scientific inquiries)

i Name

Dr Ying Y LEE

ii Address

iii Phone

yylee@ha.org.hk

iv Email

email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Spinal anaesthesia for lower limb surgery: dose-response study of ropivacaine

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

n/a

12 Countries of Recruitment

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-04-14

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Lower limb surgery

15Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Spinal anaesthesia using ropivacaine

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Approx 2-3 hours

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

Varying doses of intrathecal ropivacaine

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion: ASA 1-3 patients, >18years, weight 45-85 kg, height >150 cm having spinal anaesthesia for lower limb surgery. Exclusion: hypersensitivity to local anaesthetics, contraindications to spinal anaesthesia, inability to understand Chinese or English.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-06-01

21 Target Sample Size

60

22 Recruitment Status

Complete

23 Primary Outcome

Effectiveness of spinal anaesthesia

24 Secondary Outcome

n/a

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2013-01-10

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

n/a

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Trial History Detail on 2007-09-14