Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00271

2 Trial Registration Date

2010-10-25

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Department resources (The Department of Anesthesia and Intensive Care)

5 Primary Sponsor

Nil

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 Anesthesia and Intensive Care

iii Phone

26322735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anesthesia and Intensive Care

vi Country

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

26322735

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anesthesia and Intensive Care

vi Country

9 Official Scientific Title of the Study

Prospective Randomized Evaluation of the Haemodynamic Effects in the Ipsilateral Upper Extremity after an Ultrasound Guided Axillary or Supraclavicular Brachial Plexus Block

10 Public Title

Prospective Randomized Evaluation of the Haemodynamic Effects in the Ipsilateral Upper Extremity after an Ultrasound Guided Axillary or Supraclavicular Brachial Plexus Block

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Haemodynamic effects of ipsilateral brachial plexus block

12 Countries of Recruitment

China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2010-07-14

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

Procedure

Please specify

ii Description/ name of Intervention/article

Ultrasound guided brachial plexus block through either the axillary or supraclavicular route

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

30 minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

The changes in arterial haemodynamics in the upper extremity will be compared between ultrasound guided axillary and supraclavicular brachial plexus block.

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

28 consenting adult patients, ASA І-II, undergoing forearm or hand surgery at the Prince of Wales Hospital will be recruited

ii Exclusion Criteria

Patient refusal, ASA physical status>Ⅲ, hypertension, cardiac disease, autonomic dysfunction, diabetes mellitus, nerve injury or neuropathy disorders, connective tissue disorders, diagnosed peripheral vascular disease, status of coagulation or anticoagulation, skin infection at the site of needle insertion, a contraindication to regional anaesthesia, the presence of an arteriovenous fistula in the arm, sepsis, and pregnancy

iii Age Minimum

19

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

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

2010-08-28

21 Target Sample Size

28

22 Recruitment Status

Complete

23 Primary Outcome

Haemodynamic parameters (PSV, EDV, ratio of PSV and EDV (S/D), Vmean, TAVM, RI and PI) and diameter measurement will be performed in brachial artery and common palmar digital artery before the brachial plexus block, and repeated at regular intervals for 30 minutes, (5min, 10min, 20min, and 30mins) after the ultrasound guided BPB. At the same time intervals, heart rate and blood pressure will be also recorded. Skin temperature in the palmar aspect of both thumbs will be also recorded at the same time intervals. Core temperature will be also recorded at 30 min after the BPB to determine if there are any changes in core temperature during the study period.

24 Secondary Outcome

Success of the block will be defined as abolition of sensation to cold (ice) and paralysis of the muscles in the ipsilateral hand and forearm and will be assessed at the same time intervals as the haemodynamic measurements after the brachial plexus block.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-11-13

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-10001095

28 Date of Registration in Primary Registry

2010-12-01

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2012-11-13