Intradermal Lidocaine Via MicronJet600 Microneedle Device

NCT ID: NCT05108714

Last Updated: 2021-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2019-03-17

Brief 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

Keywords

Microneedles, local anaesthesia, intradermal administration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

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.

Group Type: PLACEBO_COMPARATOR

Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Intravenous cannulation after without prior interventions

Intervention Type: PROCEDURE

insertion of 18G catheter in a cubital vein without prior interventions.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Intravenous cannulation after without prior interventions

insertion of 18G catheter in a cubital vein without prior interventions.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NanoPass Technologies Ltd

INDUSTRY

Sponsor Role: collaborator

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chavdar Dr Pavlov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Locations

University Clinical Hospital №2 (I.M. Sechenov First Moscow State Medical University (Sechenov University))

Moscow, , Russia

Countries

Russia

References

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.

Reference Type: DERIVED

PMID: 35100279 (View on PubMed)

Other Identifiers

1.1.

Identifier Type: -

Identifier Source: org_study_id