Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00391

2 Trial Registration Date

2014-01-22

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.637-T

4 Source(s) of Funding

Department resources (The Department of Anesthesia and Intensive Care)

5 Primary Sponsor

Prof Karmakar at the Department of Anesthesia and Intensive Care

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 Anesthesia and Intensive Care

iii Phone

26323155

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anesthesia and Intensive Care

vi Country

Hong Kong SAR, China

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

i Name

Manoj K Karmakar

ii Address

Department of Anesthesia and Intensive Care

iii Phone

26322737

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anesthesia and Intensive Care

vi Country

HK SAR China

9 Official Scientific Title of the Study

Multi-level Thoracic Paravertebral Block and Its Effects on Acute and Chronic Pain, and Health-Related Quality of Life after Major Breast Cancer Surgery. Changed to new title in 2018 as: Thoracic Paravertebral Block and the Risk of Developing Chronic Pain after Major Breast Cancer Surgery. A Prospective Randomized Study Comparing a Single-level versus Multi-level Thoracic Paravertebral Block

10 Public Title

Thoracic Paravertebral Block and the Risk of Developing Chronic Pain after Major Breast Cancer Surgery. A Prospective Randomized Study Comparing a Single-level versus Multi-level Thoracic Paravertebral Block

i Public Title in Chinese 研究名稱

前瞻性隨機對照單平面和多平面胸椎旁阻滯對乳腺癌術後慢性疼痛發生的風險研究

11 Short Title (Optional)

Multi-level Thoracic Paravertebral Block and quality of life

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?

2014-01-20

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2013.637-T

14 Medical Condition Being Studied

Breast cancer in females

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Ultrasound guided multi-level thoracic paravertebral nerve block

iii Dosage form of the intervention

not pharmaceutical study

iv Dosage of the intervention

not pharmaceutical study

v Duration of the intervention

30 minutes

vi Frequency of the intervention

once

16 Comparative Treatments

i Description/ name of comparative treatments

In this study, there are two study groups. In both groups three injections will be made in the back. In one group, local anesthetic will be injected in all the three levels; while in the other group, local anesthetic will be injected in one thoracic level and saline will be injected subcutaneously or intramuscularly in the other two levels. You will be assigned to one of the two groups randomly. There is 50:50 chance of each group which is determined by the allocation. No matter which drug is used, it will not affect your surgery because rescue analgesia will be administered whenever necessary during the surgery. The whole procedure will last approximately 20-30 minutes.

ii Dosage form of the comparative treatments

not pharmaceutical study

iii Dosage of the comparative treatments

not pharmaceutical study

iv Duration of the comparative treatments

30 minutes

v Frequency of the comparative treatments

once

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

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 received opioid or drugs with antiemetic properties in the 24 h before surgery, patients who received chemotherapy or radiotherapy before surgery and patients with breast pain before surgery.

iii Age Minimum

30

iv Age Maximum

70

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Double blinded

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-06-27

21 Target Sample Size

220

22 Recruitment Status

Recruiting

23 Primary Outcome

The incidence of chronic pain at 3 months, 6 months, 1 year, 2 year, 3 year, 4 year, and 5 year after the surgery will be recorded.

24 Secondary Outcome

Total Additional Dose of Morphine administered during the surgery will be recorded; The pain score in the recovery room and the total morphine used in the recovery room will be recorded.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-08-11

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004201

28 Date of Registration in Primary Registry

2014-01-25

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Trial History Detail on 2019-08-08