Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00245

2 Trial Registration Date

2009-12-22

iRegistration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

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

5 Primary Sponsor

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

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Prof Warwick D. Ngan Kee

ii Address

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

iii Phone

+852 26322735

iv Email

warwick@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong,

vi Country

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

i Name

Prof Warwick D. Ngan Kee

ii Address

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

iii Phone

+852 26322735

iv Email

warwick@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A random-allocation graded dose-response study of intrathecal bupivacaine, levobupivacaine and ropivacaine for labor analgesia in nulliparous women

10 Public Title

A random-allocation graded dose-response study of intrathecal bupivacaine, levobupivacaine and ropivacaine for labor analgesia in nulliparous women

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Labour analgesia dose-response study

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2009-08-19

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Labour

15Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Bupivacaine, levobupivacaine, ropivacaine

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

15 min

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

Labouring patients randomized to an intrathecal dose ranging from 0.625 to 6.25 mg of either bupivacaine, levobupivacaine or ropivacaine. Response measured as pain scores for 15 min

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

Healthy term singleton pregnancy in painful first stage of labour

ii Exclusion Criteria

Maternal or fetal disease

iii Age Minimum

18

iv Age Maximum

51

v Gender

Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2009-12-22

21 Target Sample Size

270

22 Recruitment Status

Recruiting

23 Primary Outcome

Reduction in pain score in first 15 min after adminstration

24 Secondary Outcome

N/A

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2016-08-04

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000773

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

www.cuhk.edu.hk

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Trial History Detail on 2013-09-11