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Completed

NCT Number: NCT05108714

Intradermal Lidocaine Via MicronJet600 Microneedle Device

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.

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Key information

Conditions

Local Anaesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Moscow, 119435, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Intravenous cannulation after without prior interventions

Procedure

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

Primary outcomes

  1. Pain scores, reported by the subjects due to painful stimulus by intravenous catheterisation with 18G cannula

    Time frame: Immediately after 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.

  2. Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (1)

    Time frame: At 15 minutes after the intradermal lidocaine injection.

    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.

  3. Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (2)

    Time frame: At 30 minutes minutes after the intradermal lidocaine injection.

    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.

  4. Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (3)

    Time frame: At 45 minutes after the intradermal lidocaine injection.

    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.

  5. Prevalence of adverse events.

    Time frame: 24 hours after the lidocaine injection with MicronJet600.

    Any kind of local and systemic adverse events were recorded after the lidocaine injection with MicronJet600 followed by the intravenous cannulation.

Secondary outcomes

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

    Time frame: Immediately after the intravenous catheterisation with 18G cannula.

    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.

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Collaborators

  • NanoPass Technologies Ltd

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 5, 2021
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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