Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00101

2 Trial Registration Date

2006-04-12

i Registration Status

Retrospective

3 Secondary IDs

None

4 Source(s) of Funding

Departmental Sources

5 Primary Sponsor

Dept of Anaesthesia and Inteneive 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 Intensive Care, CUHK

iii Phone

26321311

iv Email

karmakar@cuhk.u.hk

v Affiliation

Associate Professor

vi Country

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

i Name

Manoj K Karmakar

ii Address

Dept of Anaesthesia and Intensive Care, CUHK

iii Phone

26321311

iv Email

karmakar@cuhk.u.hk

v Affiliation

Associate Professor

vi Country

9 Official Scientific Title of the Study

Comparative pharmacokinetics after thoracic paravertebral administration of levobupivacaine with or without epinephrine

10 Public Title

Professor

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Pharmacokinetics of levobupivacaine after thoracic paravertebral block

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?

2002-07-11

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

nil

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Plain levobupivacaine or levobupivacaine with epinephrine

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Single (pre incisional) injection

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Levobupivacaine or Levobupivacaine with epinephrine

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 (American Society of Anaesthesiologists) class 1-3 patients under the age of 75 years who are due to receive a thoracic paravertebral block as part of their routine perioperative management 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 evidence of coagulopathy. 4. Patient with pre-existing neurological or muscular disorders. 5. Patients with deranged liver or renal function.

iii Age Minimum

20

iv Age Maximum

60

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

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

2002-08-01

21 Target Sample Size

20

22 Recruitment Status

Complete

23 Primary Outcome

Pharmacokinetics variable Cpmax

24 Secondary Outcome

Tmax, Vd, Cl, T1/2 and MBRT over 24 hours

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-06

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000685

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2011-04-06