Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00389

2 Trial Registration Date

2014-01-21

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.554-T

4 Source(s) of Funding

Department resources (The Department of Anesthesia and Intensive Care)

5 Primary Sponsor

Prof Karmakar at The Department of Anesthesia and Intensive Care

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

26323155

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Prince of Wales Hospital, The Chinese University of Hong Kong

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

26322737

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Prince of Wales Hospital, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A Randomized Comparison of Medial and Lateral Approaches for Ultrasound Guided Infraclavicular Brachial Plexus Block

10 Public Title

A Randomized Comparison of Medial and Lateral Approaches for Ultrasound Guided Infraclavicular Brachial Plexus Block

i Public Title in Chinese 研究名稱

超聲波引導的內側和外側鎖骨下窩臂叢神經阻滯的隨機性對照研究

11 Short Title (Optional)

Ultrasound Guided Infraclavicular 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?

2013-12-27

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

musculoskeletal disorders in forearm and hand which require surgery

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Ultrasound guided brachial plexus block

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

60 minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

There will be two kinds of approaches for performing the block, A & B, A = medial approach, B = lateral approach. There is a 50:50 chance of getting either method which is determined by the allocation. Your sensation to pinprick and motor function will be tested repeatedly after the block at 5-15 minutes intervals for 45 minutes. The onset time of sensory block will be compared for the two teniques.

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

Patients of ASA physical status Ⅰ-Ⅱ, who are aged between 20 to 70 years and scheduled to undergo elective forearm or hand surgery, unrelated to trauma, under brachial plexus block will be prospectively enrolled.

ii Exclusion Criteria

Patient refusal, ASA physical status > Ⅲ, pregnancy, neuromuscular disorder, prior surgery in the infraclavicular fossa, coagulopathy, allergy to local anesthetic drugs, and skin infection at the site of needle insertion will be excluded.

iii Age Minimum

20

iv Age Maximum

70

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

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

2014-02-19

21 Target Sample Size

50

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

The sensory and motor function in the ipsilateral hand and forearm will also be evaluated by a blinded observer (research nurse) at regular intervals for 45 minutes (5 min, 10 min, 15 min, 20 min, 30 min, and 45 min) after the infraclavicular BPB

24 Secondary Outcome

The occurance of paresthesia, abnormal sensation and motor weakness will be followed up at 48 hours and 1 week after the block.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-03-30

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004199

28 Date of Registration in Primary Registry

2014-01-25

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2014-01-28