Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00574

2 Trial Registration Date

2018-01-09

i Registration Status

Prospective

3 Secondary IDs

CREC.2017.498-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,
4/F Main Clinical Block & Trauma Centre,
Prince of Wales Hospital,
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,
4/F Main Clinical Block & Trauma Centre,
Prince of Wales Hospital,
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 Prospective Randomized Comparison of the Effects of Lidocaine and Ropivacaine on Block Dynamic after a Costoclavicular Brachial Plexus Block

10 Public Title

A Prospective Randomized Comparison of the Effects of Lidocaine and Ropivacaine on Block Dynamic after a Costoclavicular Brachial Plexus Block

i Public Title in Chinese 研究名稱

前瞻性隨機比較使用利多卡因(Lidocaine)和羅呱卡因(Ropivacaine)對肋鎖間的鎖骨下窩臂叢神經阻滯後阻滯動態的效果

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?

2017-11-14

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC. 2017.498-T

14 Medical Condition Being Studied

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

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

To compare the onset of sensory-motor blockade in the ipsilateral upper extremity between two local anaesthetic drugs i.e. “lidocaine” and “ropivacaine” via the costoclavicular space for brachial plexus block (costoclavicular brachial plexus). Lidocaine and ropivacaine are commonly used local anesthetic agents in daily clinical practice for patients requiring to have surgery under local or regional anesthesia

iii Dosage form of the intervention

Under ultrasound guidance, patient will receive either 1.5% lidocaine with adrenaline 25 ml, or 0.5% ropivacaine 25 ml injected at infraclavicular brachial plexus

iv Dosage of the intervention

Patient will receive either 1.5% lidocaine with adrenaline 25 ml, or 0.5% ropivacaine 25 ml

v Duration of the intervention

1 hour

vi Frequency of the intervention

once before operation

16 Comparative Treatments

i Description/ name of comparative treatments

One group of patients will receive lidocaine with adrenaline and another group will receive ropivacaine.

ii Dosage form of the comparative treatments

Under ultrasound guidance, patient will receive either 1.5% lidocaine with adrenaline 25 ml, or 0.5% ropivacaine 25 ml injected for costoclavicular brachial plexus

iii Dosage of the comparative treatments

Patient will receive either 1.5% lidocaine with adrenaline 25 ml, or 0.5% ropivacaine 25 ml

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 Anesthesiologists (ASA) status I to III, and planned for arm, forearm and hand surgery under regional anesthesia in Prince of Wales Hospital.

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 on the same side of operation; Patients who are coagulopathic or taking anticoagulants; Patients suffering from dysaesthesia or chronic neuropathic pain at the site of surgery; History of local anesthetics allergy; Skin infection over the site of the 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

2018-02-01

21 Target Sample Size

86

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Proportion of patients achieving complete sensory and motor blockade at 30 minutes

ii The metric or method of measurement used

complete sensory & motor block means 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

24 Secondary Outcome

i The Name of the outcome

Time of readiness for surgery; Time to complete sensory and motor block; Sensory & motor scores at all the time points over all nerve distributions (median, radial, ulnar and musculocutaneous nerve); Proportion of patients achieving readiness for surgery at all time points; Paresthesis & discomfort

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); parethesia (yes or no); degree of discomfort (verbal rating scale, 0-100, 0=no pain & 100= worst imaginable pain)

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-01-26

27 Primary Registry and Trial Identifying Number

ChiCTR1800014387

28 Date of Registration in Primary Registry

2018-01-10

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Trial Detail