Clinical trial NCT05108714: Intradermal Lidocaine Via MicronJet600 Microneedle Device
Official title: The Use of MicronJet600 Microneedle for Intradermal Lidocaine Injection to Ensure Local Anaesthesia During Insertion of Peripheral Venous Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anaesthesia
Keywords: Microneedles, local anaesthesia, intradermal administration
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
Collaborators: name: NanoPass Technologies Ltd
First posted: 2021-11-05
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain scores, reported by the subjects due to painful stimulus by intravenous catheterisation with 18G cannula
timeFrame: Immediately after intravenous catheterisation with 18G cannula.
measure: Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (1)
timeFrame: At 15 minutes after the intradermal lidocaine injection.
measure: Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (2)
timeFrame: At 30 minutes minutes after the intradermal lidocaine injection.
measure: Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (3)
timeFrame: At 45 minutes after the intradermal lidocaine injection.
measure: Prevalence of adverse events.
timeFrame: 24 hours after the lidocaine injection with MicronJet600.
Secondary outcomes:
measure: Preference to receive injection of lidocaine with MicronJet600 prior to intravenous cannulation, over the cannulation without any pre-treatment.
timeFrame: Immediately after the intravenous catheterisation with 18G cannula.
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: University Clinical Hospital №2 (I.M. Sechenov First Moscow State Medical University (Sechenov University))
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Chavdar Dr Pavlov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.