NCT05108714

Intradermal Lidocaine Via MicronJet600 Microneedle Device

The Use of MicronJet600 Microneedle for Intradermal Lidocaine Injection to Ensure Local Anaesthesia During Insertion of Peripheral Venous Catheters

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Local Anaesthesia

Interventions

Type	Name	Description
DEVICE	Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1)	Intradermal administration of 100 µL of lidocaine (registrational number LS001516 by Federal Service for Surveillance in Healthcare of Russian Federation) 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 immediately after the lidocaine administration.
DEVICE	Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device	Intradermal administration of 100 µL saline (registration number РN002134/01 by Federal Service for Surveillance in Healthcare of Russian Federation) 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 immediately after the saline administration.
DEVICE	Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2)	Intradermal administration of 100 µL of lidocaine (registrational number LS001516 by Federal Service for Surveillance in Healthcare of Russian Federation) 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 immediately after the lidocaine administration.
PROCEDURE	Intravenous cannulation after without prior interventions	insertion of 18G catheter in a cubital vein without prior interventions.

Timeline

• Start date: 2019-01-29
• Primary completion: 2019-03-15
• Completion: 2019-03-17
• First posted: 2021-11-05
• Last updated: 2021-11-05

Locations

1 site across 1 country: Russia