Intradermal Lidocaine Via MicronJet600 Microneedle Device

NCT05108714 | Completed DMC

• 1 other identifier: 1.1.
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Local Anaesthesia

Keywords

Microneedles, local anaesthesia, intradermal administration

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Preference to receive injection of lidocaine with MicronJet600 prior to intravenous cannulation, over the cannulation without any pre-treatment.

  Immediately after the intravenous catheterisation with 18G cannula.

Study Arms (4)

Group 1. Left arm.

EXPERIMENTAL

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)

Group 1. Right arm.

PLACEBO COMPARATOR

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

Group 2. Left arm.

EXPERIMENTAL

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)

Group 2. Right arm.

ACTIVE COMPARATOR

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

Interventions

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

Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device 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 1. Right arm.

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

Intravenous cannulation after without prior interventions PROCEDURE

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

Group 2. Right arm.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender
• Age at 18-65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead
• NanoPass Technologies Ltd: collaborator

Study Sites (1)

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

Moscow, 119435, Russia

Location

Related Publications (1)

• 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.

  PMID: 35100279 DERIVED

Study Officials

• Chavdar Dr Pavlov, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: November 5, 2021
• Study Start: January 29, 2019
• Primary Completion: March 15, 2019
• Study Completion: March 17, 2019
• Last Updated: November 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)