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Trial History Detail on 2016-01-29

CUHK_CCRB00501

2016-01-29

Prospective

CREC 2015.364-T

Investigator initiated trial

N/A

N/A

Not Applicable

Lydia Lau

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

69018306

lydialnlau@gmail.com

Prince of Wales Hospital, Hospital Authority

Hong Kong

Lydia Lau

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

69018306

lydialnlau@gmail.com

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital

Hong Kong

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

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

Lignopad 急性術後疼痛治療研究

Hong Kong

Yes

2015-12-14

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC 2015.364-T

Acute post-operative pain

Drug

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.

1 patch (700mg)

1 patch (700mg) over 24 hours

3 days

once a day

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

1 patch

1 patch over 24 hours

3 days

once a day

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

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

18

60

Female

Interventional

Randomized

Simple randomization by computer-generated numbers

Placebo

Double-blind

Parallel

4

2016-02-08

30

Not Yet Recruiting

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

Visual analogue scale (VAS) pain score

24 hours after extubation

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

Visual analogue scale (VAS) pain score

48 and 72 hours after extubation

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

PCA morphine dose used (mg)

24, 48 and 72 hours after extubation

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

Peak flow rate (ml)

24, 48 and 72 hours after extubation

Complications arising from lignopad® application

Nominal

24, 48 and 72 hours after extubation

No

2017-11-06

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