Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00331

2 Trial Registration Date

2012-08-06

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

The Chinese University of Hong Kong

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

2632 3155

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care, CUHK

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

iii Phone

2632 2735

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care, CUHK

vi Country

9 Official Scientific Title of the Study

Prospective Randomized Comparison of the Block Dynamics after a Traditional Landmark Based and Ultrasound Guided Thoracic Paravertebral Block

10 Public Title

Prospective Randomized Comparison of the Block Dynamics after a Traditional Landmark Based and Ultrasound Guided Thoracic Paravertebral Block

i Public Title in Chinese 研究名稱

前瞻性隨機比較傳統體表定位胸椎旁麻醉及超聲波引導胸椎旁麻醉的血流動力學差異

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?

2012-07-12

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

Procedure

Please specify

ii Description/ name of Intervention/article

Patients will be randomized into two groups. All of them will have their thoracic spine examined by ultrasound machine. Then one group will receive thoracic paravertebral block by traditional landmark technique, another group will receive the thoracic paravertebral block under real-time ultrasound monitoring. Both groups will be assessed for the sensation to cold (ice) at regular intervals (5, 10, 20, 30, 40min) after the paravertebral injection before undergoing general anaesthesia. Data related to the discomfort during the injection, sensation to coldness at different time intervals to determine the extent of ipsilateral and contralateral sensory block, and any complication before general anaesthesia will be collected. Interoperative vital signs (blood pressure, heart rate, oxygen saturation), and pain score, nausea score, analgesia, antiemetics and vasopressor use at recovery room till 48 hours at postoperative ward will be recorded in order to determine the incidence of hypotension between traditional landmark based thoracic paravertebral and ultrasound guided thoracic paravertebral block.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

From thoracic paravertebral block till 48 hours post operatively

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

ASA 1-3 adult female patients undergoing major breast cancer surgery

ii Exclusion Criteria

Patients with a known allergy to local anaesthetic drugs
Patient with infection at the site of block placement
Patient with a bleeding tendency or with evidence of coagulopathy
Patient with pre-existing neurological or muscular disorders.
Patient with history of psychiatric illness.
Pregnant patients
Patients with known hypertension ( SBP>140mmHg or DSP>90mmHg) or poorly controlled hypertension
Patients with ischemic heart disease, peripheral vascular disease, carotid artery stenosis, history of TIA and stroke
Patients with previous chest surgeries and radiotherapy/chemotherapy

iii Age Minimum

18 years old

iv Age Maximum

60 years old

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-09-01

21 Target Sample Size

36

22 Recruitment Status

Unknown

23 Primary Outcome

To compare the segmental sensory blockade and the incidence of hypotension after the thoracic paravertebral block till the end of operation between two groups (traditional landmark based and real time ultrasound).

24 Secondary Outcome

Sensation to cold (ice) at regular intervals (5, 10, 20, 30 and 40 min) after the paravertebral injection over the ipsilateral and contralateral chest, axilla and abdomen. Pain score, nausea score, analgesia, antiemetics and vasopressor use at recovery room till 48 hours at postoperative ward.

25 Study Information/Publication

i Study Information/Publication Available?

Yes

ii Link to Study Information/Publication

Nil

26 Last Update Date

2021-08-11

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-12002619

28 Date of Registration in Primary Registry

2012-10-26

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Trial History Detail on 2015-09-10