Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00126

2 Trial Registration Date

2007-12-05

i Registration Status

Retrospective

3 Secondary IDs

nil

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

nil

Function

Please specify

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

i Name

Prof Warwick D. Ngan Kee

ii Address

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

iii Phone

+852 26322735

iv Email

email warwick@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Prof Warwick D. Ngan Kee

ii Address

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

iii Phone

+852 26322735

iv Email

email warwick@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Dose-response analysis methodology for epidural analgesia in the first stage of labour using ropivacaine and bupivacaine

10 Public Title

Dose-response analysis methodology for epidural analgesia in the first stage of labour using ropivacaine and bupivacaine

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

nil

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?

2006-08-01

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

labour

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

ropivacaine, bupivacaine

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

30min

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Allocation to receive a single randomized dose of ropivacaine or bupivacaine epidurally for analgesia in the first stage of labour

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

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: American Society of Anesthesiologists physical status 1 or 2, nulliparous, uncomplicated singleton pregnancy, gestation greater than or equal to 36weeks, cephalic presentation, established labour with cervical dilatation less than or equal to 5 cm, baseline visual analogue scale pain score greater than or equal to 50 mm (scale: 0-100mm), requesting epidural analgesia in the first stage of labour.

ii Exclusion Criteria

Exclusion criteria: Inability or unwillingness to give informed consent, parenteral opioid received within the preceding 2 h, any contraindication to epidural analgesia or allergy to local anaesthetics.

iii Age Minimum

18

iv Age Maximum

50

v Gender

Female

18 Study Type

Interventional

19 Study 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

2006-08-09

21 Target Sample Size

50

22 Recruitment Status

Complete

23 Primary Outcome

Visual analogue scale pain scores in the first 30 min after administration.

24 Secondary Outcome

nil

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last 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 2009-11-27