Intradermal Lidocaine Via MicronJet600 Microneedle Device

Local Anaesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05108714
• Other study ID #: 1.1.
• Status: Completed
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: March 17, 2019

Study information

• Verified date: September 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 17, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Local Anaesthesia

Intervention

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.
• Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device
Intradermal administration of 100 µL saline (registration number ?N002134/01 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)
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.

Procedure:
• Intravenous cannulation after without prior interventions
insertion of 18G catheter in a cubital vein without prior interventions.

Locations

Country	Name	City	State
Russian Federation	University Clinical Hospital ?2 (I.M. Sechenov First Moscow State Medical University (Sechenov University))	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University	NanoPass Technologies Ltd

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.