Intradermal Lidocaine Via MicronJet600 Microneedle Device

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: Local Anaesthesia

Treatments: Device: Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1); Device: Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2); Device: Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device; Procedure: Intravenous cannulation after without prior interventions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05108714

1.1.

Details and patient eligibility

About

The purpose of this study is to determine efficiency and safety of injecting a micro-amount of 2% lidocaine with the commercially available microneedle device MinronJet600 (NanoPass Technologies Ltd, Israel) (registration number RZN2017/5544 by Federal Service for Surveillance in Healthcare of Russian Federation) to achieve rapid local anesthesia for peripheral venous cannulation.

Full description

The trial is prospective, randomised, open-label, placebo-controlled. The start date of patient enrolment was January 29 of 2019. Simple randomization was performed to allocate subjects into two groups using the Microsoft Excel random number generator. As a result of randomisation, subjects were allocated into two groups - Group1 and Group2.

In this study, each subject from Group1 received injection of local anaesthetic into the left arm and sterile saline as a placebo into the right arm, the injections were performed with MicronJet600 and followed by the intravenous cannulation; each subject from Group2 will receive injection of local anaesthetic into the left arm, which was performed with MicronJet600 and followed by the intravenous cannulation, with no pre-treatment prior to the intravenous cannulation in case of the right arm. Pain caused by the cannulations was rated by the subjects in accordance with 100-point visual analogue scale. Safety parameters was assessed throughout the study.

Enrollment: 102 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any gender
• Age at 18-65 years

Exclusion criteria

• Pregnant or lactating women
• Evidence of allergy to lidocaine
• Presence of pain of any localization and character not associated with the study or treatment with any analgesics
• Any perceptual disorders
• Neuropathies or stroke in anamnesis
• Any psychiatric disorders
• Any disorder of tissues at the site of intervention - the antecubital fossa

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

102 participants in 4 patient groups, including a placebo group

Group 1. Left arm.

Experimental group

Description:

Healthy subjects, who underwent the following intervention: intradermal injection of lidocaine hydrochloride injectable solution via MicronJet600 microneedle device at the site of antecubital fossa of the left arm, followed by the insertion of 18G catheter in a cubital vein.

Treatment:

Device: Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1)

Group 1. Right arm.

Placebo Comparator group

Description:

Healthy subjects, who underwent the following intervention: intradermal injection of sterile saline via MicronJet600 microneedle device at the site of antecubital fossa of the right arm, followed by the insertion of 18G catheter in a cubital vein.

Treatment:

Device: Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device

Group 2. Left arm.

Experimental group

Description:

Healthy subjects, who underwent the following intervention: intradermal injection of lidocaine hydrochloride injectable solution via MicronJet600 microneedle device at the site of antecubital fossa of the left arm, followed by the insertion of 18G catheter in a cubital vein.

Treatment:

Device: Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2)

Group 2. Right arm.

Active Comparator group

Description:

Healthy subjects, who underwent the following intervention: insertion of 18G catheter in a cubital vein at the site of antecubital fossa of the right arm, without any prior intervention.

Treatment:

Procedure: Intravenous cannulation after without prior interventions