Local Anaesthesia
Conditions
Keywords
Microneedles, local anaesthesia, intradermal administration
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.
Interventions
DEVICEIntravenous 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.
DEVICEIntravenous 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.
DEVICEIntravenous 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.
PROCEDUREIntravenous cannulation after without prior interventions
insertion of 18G catheter in a cubital vein without prior interventions.
Sponsors
NanoPass Technologies Ltd
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores, reported by the subjects due to painful stimulus by intravenous catheterisation with 18G cannula | 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. |
| Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (1) | 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. |
| Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (2) | 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. |
| Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (3) | 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. |
| Prevalence of adverse events. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Russia
Outcome results
None listed