Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00492

2 Trial Registration Date

2015-12-03

iRegistration Status

Prospective

3 Secondary IDs

CREC.2015.493

4 Source(s) of Funding

Dept of Anaesthesia & Intensive Care, CUHK

5 Primary Sponsor

Dept of Anaesthesia & Intensive Care, CUHK

6 Secondary Sponsor

nil

Function

Not Applicable

Please specify

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

i Name

Winnie Samy

ii Address

Dept of Anaesthesia & Intensive Care,
Prince of Wales Hospital,
CUHK

iii Phone

26322735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

research nurse

vi Country

Hong Kong

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

i Name

Prof. Manoj Kumar Karmakar

ii Address

Dept of Anaesthesia & Intensive Care,
Prince of Wales Hospital,
CUHK

iii Phone

852 2632 1311 / 2735

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Professor

vi Country

Hong Kong

9 Official Scientific Title of the Study

Evaluation of Ipsilateral Hemidiaphragmatic Excursion Following Ultrasound-Guided Infraclavicular Brachial Plexus Blockade at the Costoclavicular space

10 Public Title

Evaluation of Ipsilateral Hemidiaphragmatic Excursion Following Ultrasound-Guided Infraclavicular Brachial Plexus Blockade at the Costoclavicular space

i Public Title in Chinese 研究名稱

評估超聲波引導從肋鎖間的鎖骨下窩臂叢神經阻滯後同側膈肌的移動

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-11-25

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC.2015.493

14 Medical Condition Being Studied

Musculoskeletal system and connective tissue

15Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

This is a prospective and observational study. We aim to recruit 30 patients who are scheduled for elective surgery of the forearm, wrist, or hand under an ultrasound-guided infraclavicular plexus block. Hemidiaphragmatic movement will be assessed by ultrasonography before and after the block. An ultrasound probe will be placed just below patient's rib cage and a few maneuvers will be performed to obtain the best view of the hemidiaphragm.

After identifying the hemidiaphragm, patient will be encouraged to perform 2 discrete breathing maneuvers: (1) normal quiet breathing and (2) deep breathing through the mouth. At each maneuver, the distance of hemidiaphragmatic movement will be measured 3 times, and the values will be averaged. The measurements will be performed 3 times: immediately before ICBPB, 30 minutes and 45 minutes after ICBPB.

iii Dosage form of the intervention

not applicable

iv Dosage of the intervention

not applicable

v Duration of the intervention

not applicable

vi Frequency of the intervention

3 times of ultrasound measurement before surgery

16Comparative 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

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients of the American Society of Anesthesiologists (ASA) physical status I-II, aged between 20 to 70 years and scheduled to undergo elective forearm or hand surgery, unrelated to trauma, under a 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, known or suspected PNP or diaphragmatic dysfunction 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

Observational

19Study 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

Other

Please specify

not applicable

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-01-15

21 Target Sample Size

30

22 Recruitment Status

Complete

23Primary Outcome

iThe Name of the outcome

Ipsilateral hemidiaphragmatic excursion following Infraclavicular Brachial Plexus Block (ICBPB) at the costoclavicular space (CC).

iiThe metric or method of measurement used

ultrasound M mode measurement in 2 discrete breathing maneuvers: (1) at rest or quiet breathing and (2) maximal forced inspiration perform through the mouth.

iiiThe timepoint(s) of primary interest

3 measurements: immediately before ICBPB, 30 minutes and 45 minutes after ICBPB

24Secondary Outcome

iThe Name of the outcome

Sensory and motor function after ICBPB, Rescue volume of 0.5% Ropivacaine, Rescue analgesia. Duration of performing the block, Incidence of paresthesia, Degree of discomfort, Duration of surgery.

iiThe metric or method of measurement used

iiiThe timepoint(s) of primary interest

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2017-08-10

27 Primary Registry and Trial Identifying Number

ChiCTR-OOC-15007503

28 Date of Registration in Primary Registry

2015-12-03

Back History

Trial Detail