Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00502

2 Trial Registration Date

2016-02-22

i Registration Status

Prospective

3 Secondary IDs

CREC.2015.667

4 Source(s) of Funding

Department of Anaesthesia & Intensive Care, CUHK

5 Primary Sponsor

Department of Anaesthesia & Intensive Care, CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Ms Winnie Samy

ii Address

Dept of Anaesthesia & Intensive Care
4/F Main Clinical Block & Trauma Centre
Prince of Wales Hospital
Shatin
NT

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

Dept of Anaesthesia & Intensive Care
4/F Main Clinical Block & Trauma Centre
Prince of Wales Hospital
Shatin
NT

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

Ultrasound-guided Multi-level Thoracic Paravertebral Block at three levels (T1, T3, and T5) in Combination with a pectoral nerve block for surgical anaesthesia during major breast cancer surgery: A Prospective Feasibility study

10 Public Title

Ultrasound-guided Multi-level Thoracic Paravertebral Block at three levels (T1, T3, and T5) in Combination with a pectoral nerve block for surgical anaesthesia during major breast cancer surgery: A Prospective Feasibility study

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

USG 3m-TPVB and a PECS block for surgical anesthesia during major breast cancer surgery: A prospective feasibility study

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?

2016-01-28

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC. 2015.667

14 Medical Condition Being Studied

breast cancer

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

This is a prospective study is to evaluate the feasibility of using 3 paravertebral injections (3m-TPVB) at T1, T3 and T5 instead of the traditional 6 injections (at T1 to T6)that are performed in combination with a PECS block for surgical anesthesia in patients undergoing major breast cancer surgery.

iii Dosage form of the intervention

3 thoracic paravertebral injections at T1, T3, and T5 and pectoral nerve block

iv Dosage of the intervention

this is not a drug test

v Duration of the intervention

Once before surgery

vi Frequency of the intervention

once before surgery

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

Adult patients, ASA physical status I-III, aged between 30 to 80 years scheduled to undergo modified radical mastectomy (MRM) or mastectomy with sentinel lymph node biopsy will be recruited.

ii Exclusion Criteria

Patient refusal, ASA physical status > Ⅲ, BMI > 35kg/m2, spinal deformity, previous spine surgery, pregnancy, coagulopathy, allergy to local anesthetic drugs, and skin infection at the site of needle insertion will be excluded.

iii Age Minimum

30

iv Age Maximum

80

v Gender

Female

18 Study Type

Interventional

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

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-04-01

21 Target Sample Size

30

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

The success of the combined 3m-TPVB and PECS block for the breast surgery, as defined as being able to complete the major breast cancer surgery with less than 50mg of ketamine as rescue analgesia during surgery.

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

24 Secondary Outcome

i The Name of the outcome

Rescue analgesia requirement (i.e total dose of ketamine and dexmedetomidine infusion administered during the intraoperative period); surgeon's satisfaction score (0-100) at the end of the surgery.

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-01-09

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2016-02-22