Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00487

2 Trial Registration Date

2015-11-10

i Registration Status

Prospective

3 Secondary IDs

CREC. 2015.331

4 Source(s) of Funding

Department of Anaesthesia & Intensive Care, CUHK

5 Primary Sponsor

Department of Anaesthesia & Intensive Care, CUHK

6 Secondary Sponsor

nil

Function

Not Applicable

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,
Prince of Wales Hospital
The Chinese University of Hong Kong

iii Phone

2632 2735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

research nurse

vi Country

Hong Kong, China

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

i Name

Manoj Kumar Karmakar

ii Address

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

iii Phone

852 2632 1311 / 2735

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Professor

vi Country

Hong Kong, China

9 Official Scientific Title of the Study

Chronic Pain After Major Breast Cancer Surgery. A Retrospective Analysis of Single-injection Versus Multiple-injection of Thoracic Paravertebral Block

10 Public Title

Chronic Pain After Major Breast Cancer Surgery. A Retrospective Analysis of Single-injection Versus Multiple-injection of Thoracic Paravertebral Block

i Public Title in Chinese 研究名稱

nil

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-07-20

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.331

14 Medical Condition Being Studied

Breast cancer

15 Intervention

i Types of intervention

Other

Please specify

Retrsopective study, no intervention & no direct patient contact. Waived consent requirement.

ii Description/ name of Intervention/article

This is a retrospective study reviewing clinical records of two groups of patients who previously had received thoracic paravertebral block (TPVB), either single or multiple injection, as part of their anaesthesia for major breast cancer surgery. Data recorded from the Clinical Management System (patient database of Hospital Authority) will include anaesthetic records and postoperative treatment data (i.e. radiotherapy, chemotherapy, and/or endocrine therapy), and the pain intensity, characteristics, and the incidence of chronic pain at postoperative 3 months from our previous studies CRE-2004.376-T (single injection of TPVB) and CRE-2013.497 (multiple injection of TPVB). No direct patient contact and no intervention will be performed. The result obtained will only serve as pilot data to generate hypothesis for future prospective randomized study if multiple injection of TPVB is shown to be more beneficial.

iii Dosage form of the intervention

not applicable

iv Dosage of the intervention

not applicable

v Duration of the intervention

not applicable

vi Frequency of the intervention

not applicable

16 Comparative Treatments

i Description/ name of comparative treatments

not applicable

ii Dosage form of the comparative treatments

not applicable

iii Dosage of the comparative treatments

not applicable

iv Duration of the comparative treatments

not applicable

v Frequency of the comparative treatments

not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients who had general anaesthesia and single injection of TPVB from our previous study (CRE-2004.376-T) will serve as the control group in this study. Patients who had multiple-injection of TPVB without pectoral nerve block for major breast cancer surgery including subjects of our on-going study (CRE-2013.497) will be selected. Only patients with similar demographics including age, body mass index, and American Society of Anesthesiologists (ASA) Physical Classification System, and postoperative treatment data (i.e. Radiotherapy, chemotherapy, and/or endocrine therapy) of both single-injection of TPVB and multiple-injection of TPVB will be included to ensure both groups are comparable before doing data analysis.

ii Exclusion Criteria

Patients who had chemotherapy before surgery (neoadjuvant chemotherapy) as this can cause neuropathic changes and inflict pain. Patients who had a pectoral nerve block inn addition to the multiple-injection of TPVB will be excluded.

iii Age Minimum

18

iv Age Maximum

75

v Gender

Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

retrospective study

vi Study Objectives (Optional)

This restrospective study is to evaluate whether ultrasound-guided multiple-injection (T1-T6) of thoracic paravertebral block (TPVB) can further reduce the incidence of chronic pain when compared with ultrasound-guided single-injection of TPVB for patients undergoing major breast cancer surgery.

20 Anticipated trial start date

2015-11-23

21 Target Sample Size

80

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

The incidence of chronic pain at 3 months after major breast cancer surgery

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

3 months after major breast cancer surgery

24 Secondary Outcome

i The Name of the outcome

Pain intensity and characteristics

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

3 months postoperative

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-04-06

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2015-11-10