Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00301

2 Trial Registration Date

2011-12-08

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Winnie Samy

ii Address

Department of Anaesthesia & Intensive Care, CUHK

iii Phone

26323155

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care, CUHK, PWH

vi Country

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

i Name

Manoj Kumar Karmakar

ii Address

Department of Anaesthesia & Intensive Care, CUHK, PWH

iii Phone

26321311

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care, CUHK, PWH

vi Country

9 Official Scientific Title of the Study

Thoracic Paravertebral Block for Breast Cancer Surgery: Effects on Cancer Recurrence and Long Term Survival

10 Public Title

Thoracic Paravertebral Block for Breast Cancer Surgery: Effects on Cancer Recurrence and Long Term Survival

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?

2011-08-16

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Breast Cancer

15 Intervention

i Types of intervention

Other

Please specify

Collect data from Clinical Management System, so informed consent has been exempted & approved by EC

ii Description/ name of Intervention/article

This study will involve reviewing patients’ clinical records and laboratory results from the Clinical Management System (patient database of Hospital Authority) for any cancer recurrence, metastasis or death for the coming 5 years who had participated in our previous ethics approved prospective, randomized, double-blinded study (CRE-2004.376.T) of patients having a standardized anaesthetic procedure during their breast cancer surgery.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

5 years follow-up

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

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

Patients who had participated in our previous ethics approved study “Continuous Thoracic Paravertebal Block: Effects on acute and chronic pain and Quality of life after breast cancer surgery” (CRE-2004.376.T)

ii Exclusion Criteria

Nil

iii Age Minimum

18 year old

iv Age Maximum

70 year old

v Gender

Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

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

2011-09-01

21 Target Sample Size

180

22 Recruitment Status

Recruiting

23 Primary Outcome

Review patients’ records for survival or mortality over 5 years after breast cancer surgery

24 Secondary Outcome

Review patients’ records for any incidence of metastatic spread or cancer recurrence over 5 years after breast cancer surgery

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-03-30

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

Nil

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Trial History Detail on 2011-12-08