Microneedle (MN) is a mimic of a hypodermic needle, composed of hundreds of micron-sized, out-of-plane protrusions, typically arranged in arrays on a patch that can be applied onto the skin. MN can be fabricated from a variety of materials, preferably biocompatible polymers. Maltose, a natural carbohydrate, is a safe and biocompatible product that can be fabricated into MNs that are biodegradable and soluble within several minutes. Besides, local anaesthetic agents such as lignocaine can be impregnated within the MN matrix, facilitating its transdermal delivery more efficiently which results in enhanced efficacy. So far, maltose MN efficacy in enhancing the transdermal drug delivery (TDD) of lignocaine and thus reducing the pain experienced by healthy patients requiring venepuncture prior to routine eye surgeries (phacoemulsification, trabeculectomy etc) has not been extensively studied. Hence, the objectives of this research are: 1) To evaluate the safety profile of lignocaine-embedded microneedle patch as a means of pain reduction in adult patients requiring routine vein-puncturing procedures; 2) To assess the pharmacokinetic (PK) parameters of lignocaine in the systemic circulation when the transdermal lignocaine delivery is enhanced through microneedle usage; 3) To compare the efficacy of lignocaine-embedded microneedle patch with standard 5% Eutectic Mixture of Local Anesthetics (EMLA) dermal patch for pain reduction during venepuncture procedure based on mean changes in VAS scores and skin algesimeter index (pharmacodynamic (PD) study).
Patients aged 18 years old and above
Patients requiring venepuncture for blood investigations before ophthalmological procedures
Patient with a previous history of sensitization or allergy to lignocaine.
Patient with a previous history of allergy to materials used in the study i.e., plaster, electrodes, maltose, Polyvinyl Alcohol (PVA), and Polyethylene Terephthalate (PET)
Patient exposed to analgesic usage within 24 hours prior to the procedure
Generalized skin disorder/ rash
Parallel
Lignocaine-loaded maltose microneedle array patch
Combination productA biodegradable maltose microneedle array patch containing 12.5 mg lignocaine that will be applied on the participant's dorsal aspect of the hand for 30 minutes prior to venepuncture.
EMLA 5% patch
DrugEMLA 5% cream applied on the dorsum of the participant's hand which will be subsequently covered with PVA-PET adhesive for 30 minutes prior to venepuncture
Visual Analogue Score (VAS)
VAS score is measured in a continuous scale (range 0-100). It is obtained using a Med-05-100 VAS Pain Scale ruler (Schlenker Enterprises Ltd, Lombard, USA) with 0-100 mm slider. It is measured based on the pain experienced on the venepunctured hand. Higher VAS score indicates greater intensity or degree of pain whilst lower VAS score indicates lesser pain intensity.
Skin Conductance Algesimeter Index
The skin conductance peaks per second, measured in microSiemens per second (μS/s), is obtained using PainMonitor™ (Med-Storm Innovation AS, Oslo, Norway) device on the hypothenar eminence of the opposite hand not receiving venepuncture. Higher skin conductance algesimeter index indicates greater pain intensity and lower values indicate lesser pain intensity.
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