Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00573

2 Trial Registration Date

2017-12-14

i Registration Status

Prospective

3 Secondary IDs

CREC. 2017.499-T

4 Source(s) of Funding

Department of Anaesthesia & Intensive Care, CUHK

5 Primary Sponsor

Department of Anaesthesia & Intensive Care, CUHK

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

Winnie Samy

ii Address

Department of Anaesthesia & Intensive Care
Rm 04A49, 4/F Main Clinical Block & Trauma Centre
Prince of Wales Hospital
30 Ngan Shing Street
Shatin
NT

iii Phone

3505 2735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong

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

i Name

Manoj Kumar Karmakar

ii Address

Department of Anaesthesia & Intensive Care
Rm 04A49, 4/F Main Clinical Block & Trauma Centre
Prince of Wales Hospital
30 Ngan Shing Street
Shatin
NT

iii Phone

3505 2735

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong

9 Official Scientific Title of the Study

A Randomized Controlled Trial Comparing Single and Multiple Injection for Ultrasound Guided Costoclavicular Brachial Plexus Block

10 Public Title

A Randomized Controlled Trial Comparing Single and Multiple Injection for Ultrasound Guided Costoclavicular Brachial Plexus Block

i Public Title in Chinese 研究名稱

在超聲波引導從肋鎖間的鎖骨下窩臂叢神經阻滯之單次和多次注射效果對比的隨機性對照研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

Thailand

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-11-06

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.499-T

14 Medical Condition Being Studied

Musculoskeletal disease of the upper limb that require surgery under regional anesthesia

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Ultrasound guided Costoclavicular Brachial Plexus block - single or multiple injection

iii Dosage form of the intervention

not a pharmaceutical study

iv Dosage of the intervention

not a pharmaceutical study

v Duration of the intervention

1 hour

vi Frequency of the intervention

once before operation

16 Comparative Treatments

i Description/ name of comparative treatments

This is a randomized study that will recruit subjects in Hong Kong and Thailand, and there is a 50:50 chance of getting either one injection at the center of the three cords (Brachial plexus) via single skin puncture (Single injection) or have a single skin puncture and then the needle will be redirected under ultrasound guidance to inject the local anaesthetic close to each cord (a total of 3 cords) (Multiple injections). Multiple injections are expected to provide more rapid onset of surgical anesthesia and a higher proportion of patient achieving complete block than a single injection.

ii Dosage form of the comparative treatments

Not a pharmaceutical study

iii Dosage of the comparative treatments

Not a pharmaceutical study

iv Duration of the comparative treatments

1 hour

v Frequency of the comparative treatments

once before operation

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

patients who are between 20 to 70 years of age, of American Society of Anesthesiologist physical status I to III and planned for arm, forearm and hand surgery under regional anesthesia.

ii Exclusion Criteria

Patients who refuse regional anesthesia or unwilling to participate in the study; ASA physical status more than III; Pregnant patients; Patients with neuromuscular disorder; Prior surgery in the medial infraclavicular area ipsilateral to the site of surgery; patients who are coagulopathic or taking anticoagulants; patients suffering from dysaesthesia or chronic neuropathic pain at the site of surgery; history of local anesthetic allergy; skin infection over the site of block.

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

Prospective, randomized controlled trial

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

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-12-20

21 Target Sample Size

total 90 cases - as per randomisation sequence at the two centres.

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

The proportion of patient achieving complete block (both sensory score = 0 and motor score = 0)

ii The metric or method of measurement used

Sensory blockage (0-100), 100= normal sensation to cold, 0=no sensation to cold. Motorl blockade (3-point scale): 2=normal, 1=paresis, 0=paralysis.

iii The timepoint(s) of primary interest

At regular intervals for 50 minutes (5 min, 10min, 15min, 20min, 30min, 45min) after the block

24 Secondary Outcome

i The Name of the outcome

the time to complete blockade and time to readiness for surgery (sensory score ≤ 30 and motor score ≤ 1), block performance time, incidence of paresthesia during performing the block & complication of the technique; degree of discomfort experience by patient during injection

ii The metric or method of measurement used

Paresthesia (yes or no), & degree of discomfort (NRS: 0-100) experience by the patient during the injection.

iii The timepoint(s) of primary interest

After the block

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-08-10

27 Primary Registry and Trial Identifying Number

ChiCTR-INR-17013985

28 Date of Registration in Primary Registry

2017-12-14

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Trial Detail