Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00493

2 Trial Registration Date

2015-12-04

i Registration Status

Prospective

3 Secondary IDs

CREC. 2015.209-T

4 Source(s) of Funding

Dept of Anaethesia & Intensive Care, CUHK

5 Primary Sponsor

Dept of Anaethesia & Intensive Care, CUHK

6 Secondary Sponsor

nil

Function

Not Applicable

Please specify

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

i Name

Winnie Samy

ii Address

Dept of Anaethesia & Intensive Care
Prince of Wales Hospital
CUHK

iii Phone

26322735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

research nurse

vi Country

Hong Kong

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

i Name

Prof. Manoj Kumar Karmakar

ii Address

Dept of Anaethesia & Intensive Care
Prince of Wales Hospital
CUHK

iii Phone

2632 2735

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Professor

vi Country

Hong Kong

9 Official Scientific Title of the Study

The minimum effective volume of 0.5% Ropivacaine for ultrasound-guided Infraclavicular Brachial Plexus Block (USG ICBPB)using the costoclavicular Approach

10 Public Title

The minimum effective volume of 0.5% Ropivacaine for ultrasound-guided Infraclavicular Brachial Plexus Block (USG ICBPB)using the costoclavicular Approach

i Public Title in Chinese 研究名稱

超聲波引導從肋鎖間的鎖骨下窩臂叢神經阻滯中0.5%羅呱卡因的最小有效麻醉容量

11 Short Title (Optional)

nil

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?

2015-07-20

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC.2015.209-T

14 Medical Condition Being Studied

musculoskeletal system and connective tissue

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

This study will determine what the minimum effective volume (MEV) of 0.5% ropivacaine is for 90% patients receiving the costoclavicular approach (CC) of Infraclavicular brachial plexus block (ICBPB). Study subjects will be randomized based on ‘biased coin design’ method. Since the MEAV90 of 0.5% Ropivacaine for the CC approach of ICBPB is not known, the initial volume that will be used will be 25 mL based on our clinical experience. Depending on the success or failure of brachial plexus blockade to the previous volume, the volume for the next patient will be adjusted up or down by 2mL. For example, if the block is successful in the previous patient, the next subject will be randomized to a lower volume (89% chances) or to an identical volume (11% chances). In the case of failure, the next patient receives a higher volume.

iii Dosage form of the intervention

10-30 ml of 0.5% ropivacaine

iv Dosage of the intervention

0.5% ropivacaine

v Duration of the intervention

3 hours

vi Frequency of the intervention

once

16 Comparative Treatments

i Description/ name of comparative treatments

Not applicable

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 of American Society of Anesthesiologists (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 anaesthetic 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

Prospective, randomized and dose-ranging study

ii Nature of control

Dose comparison

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

drug is widely used clinically

vi Study Objectives (Optional)

To estimate the minimum effective anaesthetic volume (MEAV) of 0.5% Ropivacaine required to produce surgical anaesthesia during an USG ICBPB using teh costoclavicular approach in 90% of patients

20 Anticipated trial start date

2016-03-01

21 Target Sample Size

45

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Volume of 0.5% ropivacaine, sensory and motor function, rescue volume of 0.5% ropivacaine, rescue analgesia

ii The metric or method of measurement used

3 point scale: 0=no block, 1=analgesia; 2=anesthesia for senory & motor function assessment

iii The timepoint(s) of primary interest

from ICBPB to the end of surgery (approximately 3 hours)

24 Secondary Outcome

i The Name of the outcome

duration of performing the block, incidence of paresthesia, degree of discomfort, duration of surgery

ii The metric or method of measurement used

verbal rating scale 0-100 for discomfort/pain,

iii The timepoint(s) of primary interest

from ICBPB to the end of surgery (approximately 3 hours)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-02-11

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15007515

28 Date of Registration in Primary Registry

2015-12-04

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Trial History Detail on 2017-08-07