Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00103

2 Trial Registration Date

2006-04-12

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Soley funded by the Department of Anaesthesia and Intensive Care, CUHK

5 Primary Sponsor

Not applicable

6 Secondary Sponsor

Not applicable

Function

Please specify

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

i Name

Prof. Manoj K Karmakar

ii Address

iii Phone

iv Email

E-mail: karmakar@cuhk.edu.hk

v Affiliation

Associate Professor, Department of Anaesthesia and Intensive Care, CUHK, Hong Kong

vi Country

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

i Name

Prof. Manoj K Karmakar

ii Address

iii Phone

iv Email

E-mail: karmakar@cuhk.edu.hk

v Affiliation

Associate Professor, Department of Anaesthesia and Intensive Care, CUHK, Hong Kong

vi Country

9 Official Scientific Title of the Study

Prospective randomized evaluation of the benefits of combining thoracic paravertebral block with general anesthesia in patients undergoing major breast cancer surgery.

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Single-shot Thoracic paravertebral injection and breast surgery

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2000-12-15

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Pain, respiratory function, incidence of nausea and vomiting after breast surgery

15 Intervention

i Types of intervention

Other

Please specify

Thoracic paravertebral Injection

ii Description/ name of Intervention/article

Single-shot thoracic paravertebral block in conjunction with general anaesthesia

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Single (pre-incision) injection

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Only standardaized General anaesthesia with no paraverterbal injection

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

Inclusion: All consenting adult ASA 1-3 patients under the age of 75 years undergoing major breast cancer surgery will be recruited for this study.

ii Exclusion Criteria

Exclusion: The following patients will be excluded from the study: 1. Patients with a known allergy to local anaesthetic drugs. 2. Patient with infection at the site of block placement. 3. Patient with a bleeding tendency or with evidence of coagulopathy. 4. Patient with pre-existing neurological or muscular disorders. 5. Patient with history of psychiatric illness. 6. Pregnant patients. 7. Patients with pre-existing nausea or vomiting. 8. Patients who in the 24 h before surgery received opioids or drugs with antiemetic properties.

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-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

2001-01-01

21 Target Sample Size

90

22 Recruitment Status

Complete

23 Primary Outcome

Postoperative nausea and vomiting

24 Secondary Outcome

Postoperative pain, spirometry (FVC, FEV1 and PEFR)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2006-04-12

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000687

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

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Trial History Detail on 2011-02-08