Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00592

2 Trial Registration Date

2018-03-09

i Registration Status

Prospective

3 Secondary IDs

CREC.2017.639

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

Rm 04A49, 4/F Main Clinical Block & Trauma Centre
Prince of Wales Hospital
30 Ngan Shing Street
Shatin
New Territories
Hong Kong

iii Phone

3505 2735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong SAR

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

i Name

Prof Manoj Kumar Karmakar

ii Address

Rm 04A49, 4/F Main Clinical Block & Trauma Centre
Prince of Wales Hospital
30 Ngan Shing Street
Shatin
New Territories
Hong Kong

iii Phone

3505 2735

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong SAR

9 Official Scientific Title of the Study

Brachial Plexus Block (BPB) and its effects on Regional tissue Oxygen saturation (rSO2) in the ipsiliateral upper extremity

10 Public Title

Brachial Plexus Block (BPB) and its effects on Regional tissue Oxygen saturation (rSO2) in the ipsiliateral upper extremity

i Public Title in Chinese 研究名稱

臂叢神經阻滯對同側上肢局部組織血氧飽和度的影響

11 Short Title (Optional)

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?

2018-02-22

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC.2017.639

14 Medical Condition Being Studied

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

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

This prospective, observational cohort study will use a non-invasive regional oximetry system called O3 system (O3, Masimo Corporation, Irvine, CA, USA), which is commercially available for more than a decade, to measure the regional changes in tissue hemoglobin oxygenation (rSO2) in the thenar eminence of the ipsilateral upper extremity after an ultrasound guided costoclavicular brachial plexus block.

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

not applicable. This is an observational study, so no control group to compare.

ii Dosage form of the comparative treatments

not applicable

iii Dosage of the comparative treatments

not applicable

iv Duration of the comparative treatments

not applicable

v Frequency of the comparative treatments

not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients who are between 20 to 70 years of age; American Society of Anesthesiologists (ASA) status I to III and planned for arm, forearm and hand surgery, unrelated to trauma, under regional anaesthesia will be prospectively enrolled in Prince of Wales Hospital.

ii Exclusion Criteria

1. Patients who refuse regional anesthesia or unwilling to participate in the study 2. ASA physical status more than III 3. Pregnant patients 4. Patients with neuromuscular disorder 5. Prior surgery in the medial infraclavicular area on the same side of operation 6. Patients who are coagulopathic or taking anticoagulants 7. Patients suffering from dysaesthesia or chronic neuropathic pain at the site of surgery 8. History of local anesthetics allergy 9. Skin infection over the site of the block. 10. Patients taking vasodilator drugs.

iii Age Minimum

20

iv Age Maximum

70

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-03-28

21 Target Sample Size

20

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Percentage change in regional tissue oxygenation (rSO2) values in the upper extremity after the costoclavicular brachial plexus block (CCBPB) when compared to the baseline.

ii The metric or method of measurement used

rSO2 values measured by regional oximetry system (O3 system, Masimo Corporation, Irvine, CA, USA)

iii The timepoint(s) of primary interest

before block as baseline, and at regular intervals for 45 minutes (5 min, 10 min, 15 min, 20 min, 30 min, 45 min) after the block

24 Secondary Outcome

i The Name of the outcome

Proportion of patients achieving complete sensory & motor blockade at 30 minutes; Time of readiness for surgery; time to complete sensory & motor block; sensory & motor scores at all time points over all nerve distributions; skin temperatures at tip of thumbs. Hemodynamics (HR & BP)

ii The metric or method of measurement used

Readiness for surgery (sensory score ≤ 30 and motor score ≤1); complete sensory and motor block (sensory score = 0 and motor score = 0)

iii The timepoint(s) of primary interest

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

Secondary Outcome

i The Name of the outcome

duration of anesthesia (sensory & motor blockade); paresthesia

ii The metric or method of measurement used

sensory & motor blockade (sensory score 0-100: 0=no sensation & 100=normal sensation; motor score 2=no block, 1=paresis, & 0=paralysis); paresthesia (yes or no)

iii The timepoint(s) of primary interest

48 hours and 1 week after surgery

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

ChiCTR1800015148

28 Date of Registration in Primary Registry

2018-03-10

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Trial History Detail on 2019-08-08