Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00618

2 Trial Registration Date

2018-08-09

i Registration Status

Prospective

3 Secondary IDs

CREC.2018.298

4 Source(s) of Funding

Department of Anaesthesia & Intensive Care, CUHK

5 Primary Sponsor

Department of Anaesthesia & Intensive Care, CUHK

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

Winnie Samy

ii Address

Rm 04C09, 4/F, Main Clinical Block & Trauma Centre
Prince of Wales Hospital
Ngan Shing Street
Shatin
NT
HK

iii Phone

35052735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong SAR, China

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

i Name

Prof Manoj Kumar Karmakar

ii Address

Rm 04A49, 4/F, Main Clinical Block & Trauma Centre
Prince of Wales Hospital
Ngan Shing Street
Shatin
NT
HK

iii Phone

35052735

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong SAR, China

9 Official Scientific Title of the Study

Ultrasound Guided Thoracic Paravertebral Block for Breast Cancer Surgery. A Retrospective Review of Complications.

10 Public Title

Ultrasound Guided Thoracic Paravertebral Block for Breast Cancer Surgery. A Retrospective Review of Complications.

i Public Title in Chinese 研究名稱

not applicable, no active patient involvement, No Chinese title, Informed consent Waived

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-07-12

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC. 2018.298

14 Medical Condition Being Studied

breast cancer

15 Intervention

i Types of intervention

Other

Please specify

Retrospectively collect data to evaluate procedure done within the period of May 2011 to June 2018

ii Description/ name of Intervention/article

Thoracic Paravertebral Block (TPVB) for breast cancer surgery had been performed using landmark-based technique since 2001 in our institution. With the ongoing refinement of technique and advancement in ultrasound technology, we have established a system of performing ultrasound guided (USG) TPVB since 2011, and included single and multiple injections, or combined with other non-neuraxial blocks under general anaesthesia or intravenous sedation for different types of breast cancer surgery. This retrospective case review will evaluate and audit our practice including the technique, safety, efficacy and related complications from May 2011 to June 2018. There will be no patient contact or intervention. All data will be collected from Clinical Management System (CMS) and hospital notes.

iii Dosage form of the intervention

not a pharmaceutical study

iv Dosage of the intervention

not a pharmaceutical study

v Duration of the intervention

no active intervention will be done on patients. This review involve data collection from CMS once.

vi Frequency of the intervention

Collect data from CMS once

16 Comparative Treatments

i Description/ name of comparative treatments

no comparative treatment

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

All cases that had ultrasound guided TPVB for breast cancer surgery performed by Principal Investigator within the period of May 2011 to June 2018

ii Exclusion Criteria

Cases did not have ultrasound guided TPVB for breast cancer surgery, or had the operation before May 2011, and those who had ultrasound guided TPVB, but not performed by PI

iii Age Minimum

18

iv Age Maximum

100

v Gender

Both Male and 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

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-08-15

21 Target Sample Size

500

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

To review all the ultrasound guided TPVB that had been done since May 2011 for breast cancer surgery in terms of safety, efficacy, and complication rate according to the levels of TPVB injected

ii The metric or method of measurement used

All anesthetic agents & dosage used during surgery; number of levels of TPVB performed; pain score upon arrival & discharge from Post Anaesthetic Care Unit (PACU); any failed blocks or adverse events, any rescue analgesia, vasopressor, or antiemetic used & the dosage given during the stay at PACU.

iii The timepoint(s) of primary interest

perioperative period till discharge from PACU to ward.

24 Secondary Outcome

i The Name of the outcome

nil

ii The metric or method of measurement used

nil

iii The timepoint(s) of primary interest

nil

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-08-08

27 Primary Registry and Trial Identifying Number

ChiCTR1800018354

28 Date of Registration in Primary Registry

2018-08-09

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Trial History Detail on 2018-12-05