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

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.

Study Overview

• Status: Completed
• Conditions: Local Anaesthesia
• Intervention / Treatment: Device: Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1); Device: Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device; Device: Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2); Procedure: Intravenous cannulation after without prior interventions

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119435
    • University Clinical Hospital №2 (I.M. Sechenov First Moscow State Medical University (Sechenov University))

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1. Left arm.; 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.	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.
Placebo Comparator: Group 1. Right arm.; 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.	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.
Experimental: Group 2. Left arm.; 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.	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.
Active Comparator: Group 2. Right arm.; 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.	Procedure: Intravenous cannulation after without prior interventions; insertion of 18G catheter in a cubital vein without prior interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores, reported by the subjects due to painful stimulus by intravenous catheterisation with 18G cannula	Pain scores experienced by the subjects due to intravenous catheterisation with 18G cannula. were recorded by using a 100-point visual analogue scale.	Immediately after intravenous catheterisation with 18G cannula.
Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (1)	Pain scores experienced by the subjects due to a pin-prick with a 27G needle at 1, 2 and 3 centimetres from the site of intradermal lidocaine injection were recorded by using a 100-point visual analogue scale.	At 15 minutes after the intradermal lidocaine injection.
Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (2)	Pain scores experienced by the subjects due to a pin-prick with a 27G needle at 1, 2 and 3 centimetres from the site of intradermal lidocaine injection were recorded by using a 100-point visual analogue scale.	At 30 minutes minutes after the intradermal lidocaine injection.
Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (3)	Pain scores experienced by the subjects due to a pin-prick with a 27G needle at 1, 2 and 3 centimetres from the site of intradermal lidocaine injection were recorded by using a 100-point visual analogue scale.	At 45 minutes after the intradermal lidocaine injection.
Prevalence of adverse events.	Any kind of local and systemic adverse events were recorded after the lidocaine injection with MicronJet600 followed by the intravenous cannulation.	24 hours after the lidocaine injection with MicronJet600.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference to receive injection of lidocaine with MicronJet600 prior to intravenous cannulation, over the cannulation without any pre-treatment.	Preference to receive injection of lidocaine with MicronJet600 before intravenous cannulation over the cannulation without any pre-treatment in subjects of Group2. The preference was recorded with the 5-point Likert scale.	Immediately after the intravenous catheterisation with 18G cannula.

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Collaborators: NanoPass Technologies Ltd
• Investigators: Principal Investigator: Chavdar Dr Pavlov, MD, PhD, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Publications and helpful links

General Publications

• Rzhevskiy A, Popov A, Pavlov C, Anissimov Y, Zvyagin A, Levin Y, Kochba E. Intradermal injection of lidocaine with a microneedle device to provide rapid local anaesthesia for peripheral intravenous cannulation: A randomised open-label placebo-controlled clinical trial. PLoS One. 2022 Jan 31;17(1):e0261641. doi: 10.1371/journal.pone.0261641. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 17, 2019

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Microneedles, local anaesthesia, intradermal administration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 1.1.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The local ethics committee of the Sechenov University does not allow to share IPD; it is possible only upon an official request addressed to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No