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Trial History Detail on 2019-08-08

CUHK_CCRB00592

2018-03-09

Prospective

CREC.2017.639

Department of Anaesthesia & Intensive Care, CUHK

Department of Anaesthesia & Intensive Care, CUHK

NA

Not Applicable

Winnie Samy

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

3505 2735

wsamy@cuhk.edu.hk

Department of Anaesthesia & Intensive Care

Hong Kong SAR

Prof Manoj Kumar Karmakar

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

3505 2735

karmakar@cuhk.edu.hk

Department of Anaesthesia & Intensive Care

Hong Kong SAR

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

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

臂叢神經阻滯對同側上肢局部組織血氧飽和度的影響

Hong Kong

Yes

2018-02-22

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC.2017.639

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

Device

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.

not a pharmaceutical study

not a pharmaceutical study

1 hour

once before operation

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

not applicable

not applicable

not applicable

not applicable

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.

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.

20

70

Both Male and Female

Observational

Non-randomized

Not Applicable

Not Applicable

Not Applicable

4

2018-03-28

20

Recruiting

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

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

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

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)

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

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

duration of anesthesia (sensory & motor blockade); paresthesia

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)

48 hours and 1 week after surgery

No

2020-08-10

ChiCTR1800015148

2018-03-10

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