Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00102

2 Trial Registration Date

2006-04-12

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Departmental

5 Primary Sponsor

Department of Anaesthesia and Intensive Care, CUHK

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Manoj K Karmakar

ii Address

Dept of Anaesthesia and Itensive Care, CUHK

iii Phone

iv Email

E-mail: karmakar@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Manoj K Karmakar

ii Address

Dept of Anaesthesia and Itensive Care, CUHK

iii Phone

iv Email

karmakar@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Prospective Randomized Evaluation of the Quality of Recovery after Major Breast cancer Surgery in patients reciving either total intravenous anesthesia (TIVA) or thoracic epidural anesthesia.

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Quality of Recovery after Major 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?

2002-08-07

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

quality of recovery after breast surgery

15 Intervention

i Types of intervention

Other

Please specify

Thoracic epidural anaesthesia or Total intravenous anaesthesia

ii Description/ name of Intervention/article

Total intravenous Anaesthesia or Thoraci epidural anaesthesia

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Only for surgery

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Thoracic epidural anaesthesia and Total intravenous anaesthesia

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. Local infection at or in the vicinity of the epidural catheter placement. 3. Patient with a bleeding tendency or with evidence of coagulopathy. 4. Patient with pre-existing neurological or muscular disorders. 5. Patients with spinal deformities. 6. Patient with history of psychiatric illness. 7. Patient with history of chronic pain. 8. Patients with a history of significant cardiovascular, respiratory or gastrointestinal disease. 9. Pregnant patients. 10. Patients with pre-existing nausea or vomiting. 11. Patients who in the 24 h prior to surgery had 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

Placebo

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

2002-09-01

21 Target Sample Size

40

22 Recruitment Status

Complete

23 Primary Outcome

Quality of Recovery Score

24 Secondary Outcome

Post operative pain score, incidence of nausea and vomiting, analgesic requirement

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-09000686

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 2012-08-31