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

i Registration 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

Not Applicable

Please specify

7 Responsible 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

Hong Kong, China

8 Research 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

Hong Kong, China

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

為頭產婦女分娩鎮痛脊髓內注射bupivacaine, levobupivacaine 和 ropivacaine的隨機分配分量反應硏究

11 Short Title (Optional)

Labour analgesia dose-response study

12 Countries of Recruitment

Hong Kong

13 Research 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

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2009.290-T

14 Medical Condition Being Studied

Labour

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Bupivacaine, levobupivacaine, ropivacaine

iii Dosage form of the intervention

intrathecal injection

iv Dosage of the intervention

0.0625 - 6.25 mg

v Duration of the intervention

15 min

vi Frequency of the intervention

once

16 Comparative 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

intrathecal injection

iii Dosage of the comparative treatments

0.625 - 6.25 mg

iv Duration of the comparative treatments

15 min

v Frequency of the comparative treatments

once

17 Key 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

19 Study Design

i Randomization

Randomized

Please specify

Randomized

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

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2009-12-22

21 Target Sample Size

270

22 Recruitment Status

Complete

23 Primary Outcome

Reduction in pain score in first 15 min after adminstration

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last 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

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Trial History Detail on 2016-08-04