Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00501

2 Trial Registration Date

2016-01-29

i Registration Status

Prospective

3 Secondary IDs

CREC 2015.364-T

4 Source(s) of Funding

Investigator initiated trial

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Lydia Lau

ii Address

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, HK

iii Phone

69018306

iv Email

lydialnlau@gmail.com

v Affiliation

Prince of Wales Hospital, Hospital Authority

vi Country

Hong Kong

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

i Name

Lydia Lau

ii Address

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, HK

iii Phone

69018306

iv Email

lydialnlau@gmail.com

v Affiliation

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital

vi Country

Hong Kong

9 Official Scientific Title of the Study

Efficacy and Safety of Lignopad in Acute Post-operative Pain Management

10 Public Title

Efficacy and Safety of Lignopad® (5% lignocaine medicated plaster) in Acute Post-operative Pain Management (A Pilot Study)

i Public Title in Chinese 研究名稱

Lignopad 急性術後疼痛治療研究

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?

2015-12-14

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC 2015.364-T

14 Medical Condition Being Studied

Acute post-operative pain

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

5% lignocaine medicated plaster (lignopad®) is a 10cm x 14cm white hydrogel plaster, each containing 700mg (5% w/w) lignocaine, which diffuses continuously into the applied skin, providing a local analgesic effect, and pain relief was effective and observed 30 minutes after application . It has a low systemic absorption rate and high safety profile.

iii Dosage form of the intervention

1 patch (700mg)

iv Dosage of the intervention

1 patch (700mg) over 24 hours

v Duration of the intervention

3 days

vi Frequency of the intervention

once a day

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo patch of same size made of Omnifix® (commonly used latex-free dressing retention tape) and sterile gauze

ii Dosage form of the comparative treatments

1 patch

iii Dosage of the comparative treatments

1 patch over 24 hours

iv Duration of the comparative treatments

3 days

v Frequency of the comparative treatments

once a day

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patient 18-60 years old

Planned major abdominal non-malignant gynaecological surgery

Planned open midline surgical incision

Willing and able to give consent

ASA (American Society of Anaesthesiologists) Class 1 to 2

ii Exclusion Criteria

Patient refused either intravenous PCA or lignopad®

Contraindicated to lignopad®: hypersensitivity to local anaesthetics of the amide type; inflamed or injured skin peri-surgical site (e.g. atopic dermatitis, open wounds)

Planned transverse or oblique incisional approach

Allergy or tolerance to opiates

Extensive existing midline abdominal scarring

Unable to communicate in English or Chinese

iii Age Minimum

18

iv Age Maximum

60

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Simple randomization by computer-generated numbers

ii Nature of control

Placebo

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

2016-02-08

21 Target Sample Size

30

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Difference in mean visual analogue scale (VAS) pain score at rest and on movement at 24 hours after extubation

ii The metric or method of measurement used

Visual analogue scale (VAS) pain score

iii The timepoint(s) of primary interest

24 hours after extubation

24 Secondary Outcome

i The Name of the outcome

Mean visual analogue scale (VAS) pain scores at rest and on movement at 48 and 72 hours after extubation

ii The metric or method of measurement used

Visual analogue scale (VAS) pain score

iii The timepoint(s) of primary interest

48 and 72 hours after extubation

Secondary Outcome

i The Name of the outcome

Intravenous PCA morphine consumption at 24, 48 and 72 hours after extubation

ii The metric or method of measurement used

PCA morphine dose used (mg)

iii The timepoint(s) of primary interest

24, 48 and 72 hours after extubation

Secondary Outcome

i The Name of the outcome

Pre-operative and post-operative peak flow rate difference comparison at 24, 48 and 72 hours extubation

ii The metric or method of measurement used

Peak flow rate (ml)

iii The timepoint(s) of primary interest

24, 48 and 72 hours after extubation

Secondary Outcome

i The Name of the outcome

Complications arising from lignopad® application

ii The metric or method of measurement used

Nominal

iii The timepoint(s) of primary interest

24, 48 and 72 hours after extubation

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-11-06

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-16007868

28 Date of Registration in Primary Registry

2016-01-29

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Trial History Detail on 2016-04-01