Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00100

2 Trial Registration Date

2006-04-12

iRegistration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

RGC Grant CUHK4406/05M Project Code 2140452

5 Primary Sponsor

RGC

6 Secondary Sponsor

Department of Anaesthesia and Intensive Care

Function

Please specify

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

i Name

Manoj K Karmakar

ii Address

Department of Anaesthesiaand Inteneive Care, CUHK

iii Phone

iv Email

karmakar@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Manoj K Karmakar

ii Address

Department of Anaesthesia and Intensive Care, CUHK

iii Phone

iv Email

karmakar@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Continuous Thoracic Paravertebral Block: Effects on Acute and Chronic Pain, and Quality of Life after Breast Cancer Surgery.

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Thoracic paravertebral block and chronic pain after breast surgery

12 Countries of Recruitment

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-12-14

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

nil

15Intervention

i Types of intervention

Other

Please specify

Thoracic paravertebral block

ii Description/ name of Intervention/article

Thoracic paravertebral block

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

3 days

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

Control placebo paravertebral infusion

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: Consenting adult ASA 1-3 patients under the age of 70 years undergoing major breast cancer surgery (which includes axillary lymph node dissection) will be recruited for this study.

ii Exclusion Criteria

Exclusion: The following patients will be excluded from the study: history of chronic pain, history of regular analgesic usage, contraindication to the use of non-steroidal anti-inflammatory drugs (NSAID), known allergy to local anaesthetic drugs, infection at the site of block placement, bleeding tendency or with evidence of coagulopathy, pre-existing neurological or muscular disorders, history of psychiatric illness, pregnant patients, pre-existing nausea or vomiting, patients who in the 24 h before surgery received opioid or drugs with antiemetic properties, patients who received chemotherapy or radiotherapy before surgery and patients with breast pain before surgery.

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

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

2005-09-01

21 Target Sample Size

180

22 Recruitment Status

Recruiting

23 Primary Outcome

Incidence of chronic pain after breast surgery

24 Secondary Outcome

Quality of life

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2011-12-12

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