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

i Registration Status

Retrospective

3 Secondary IDs

not applicable

4 Source(s) of Funding

Departmental

5 Primary Sponsor

Department of Anaesthesia and Intensive Care

6 Secondary Sponsor

None

Function

Please specify

7 Responsible 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

+85226321311

iv Email

karmakar@cuhk.edu.hk

v Affiliation

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

vi Country

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

i Name

Manoj K Karmakar

ii Address

Department of Anaesthesia and Intensive Care, CUHK

iii Phone

+85226321311

iv Email

karmakar@cuhk.edu.hk

v Affiliation

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

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

Continuous Thoracic Paravertebral Block: Effects on Acute and Chronic Pain and Quality of Life after Breast Cancer Surgery - A 5 year follow up.

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Effects of Thoracic paravertebral block on acute and chronic pain after breast surgery

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?

2004-12-14

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Chronic Pain and Quality of Breast Cancer Surgery

15 Intervention

i Types of intervention

Other

Please specify

Thoracic paravertebral block before surgery, postoperative follow up, telephone interview

ii Description/ name of Intervention/article

Thoracic paravertebral block done before surgery, postoperative 3 days ward follow-up, 1 and 3 months telephone interview for acute pain data. Telephone interview once per year for 5 years for the incidence of chronic pain condition and quality of life after surgery.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

5 years follow up after date of surgery

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Patients are randomized into 3 groups: Control group, placebo paravertebral infusion group, Ropivacaine paravertebral infusion group

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: 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

18

iv Age Maximum

70

v Gender

Female

18 Study Type

Interventional

19 Study 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

2005-04-01

21 Target Sample Size

180

22 Recruitment Status

Complete

23 Primary Outcome

Data collection on aucte pain and quality of life at 1 and 3 months after surgery are finished.
Data collection of the incidence of chronic pain and quality of life after breast surgery over 5 years are in progress.

24 Secondary Outcome

Quality of life 5 years after surgery

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-12-12

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-06000684

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

not applicable

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Trial History Detail on 2013-09-11