Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00124

2 Trial Registration Date

2007-04-25

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

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

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

i Name

Professor Warwick D. Ngan Kee

ii Address

iii Phone

iv Email

email warwick@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Professor Warwick D. Ngan Kee

ii Address

iii Phone

iv Email

email warwick@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Determination and quantification of interactions of local anesthetics and lipophilic opioids administered intrathecally for analgesia:a pharmacodynamic modeling-based approach in labouring parturients

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-04-27

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Labour analgesia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Combined spinal epidural analgesia

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

30 min

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Bupivacaine and fentanyl will given intrathecally in different dose combinations for labour analgesia. Pain scores will be assessed for 30 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

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: Healthy ASA1-2 nulliparous single term parturients with cervical dilatation less than or equal to 5cm and baseline pain score of 50/100 or greater who request regional analgesia in labour.

ii Exclusion Criteria

Exclusion criteria: Parenteral opioid received in preceeding 2h, contradications to regional anaesthesia, allergy to bupivacaine or fentanyl, hypertension, known fetal abnormality.

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

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

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-05-21

21 Target Sample Size

300

22 Recruitment Status

Recruiting

23 Primary Outcome

Pain score at 30 min

24 Secondary Outcome

Determination of drug interactions

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-04-24

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

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Trial History Detail on 2009-11-19