Local AnaesthesiaNCT05108714
Intradermal Lidocaine Via MicronJet600 Microneedle Device
A study testing Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1), Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device and Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2) in people with Local Anaesthesia, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anaesthesia
- What is being tested?
- Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1), Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device and Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteRussia
- Study dates
- 29 Jan 2019to 17 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any gender
- Age at 18-65 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
University Clinical Hospital №2 (I.M. Sechenov First Moscow State Medical University (Sechenov University))
Moscow, 119435
About this study
Official title: The Use of MicronJet600 Microneedle for Intradermal Lidocaine Injection to Ensure Local Anaesthesia During Insertion of Peripheral Venous Catheters
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.
Read the 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.
- Conditions
- Local Anaesthesia
- Being tested
- Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1), Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device, Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2), Intravenous cannulation after without prior interventions
- Keywords
- Microneedles, local anaesthesia, intradermal administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 deviceDevice
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 interventionsProcedure or surgery
insertion of 18G catheter in a cubital vein without prior interventions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Intravenous cannulation after without prior interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: Immediately after the intravenous catheterisation with 18G cannula.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start29 Jan 2019
- Primary completion15 Mar 2019
- Study completion17 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Local AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- NanoPass Technologies Ltd
- Responsible party
- Sponsor
- Investigators
- Chavdar Dr Pavlov, MD, PhD, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108714
- Sponsor's protocol ID
- 1.1.
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The local ethics committee of the Sechenov University does not allow to share IPD; it is possible only upon an official request addressed to the principal investigator.
Publications
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.
PubMed 35100279
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of MicronJet600 Microneedle for Intradermal Lidocaine Injection to Ensure Local Anaesthesia During Insertion of Peripheral Venous Catheters
- ClinicalTrials.gov ID
- NCT05108714
- Acronym / sponsor ID
- 1.1.
- Conditions
- Local Anaesthesia
- Keywords
- Microneedles, local anaesthesia, intradermal administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Collaborators
- NanoPass Technologies Ltd
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 17 Mar 2019 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1. Left arm. | Experimental | Device: Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1)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. |
| Group 1. Right arm. | Placebo comparator | Device: Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle deviceHealthy 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. |
| Group 2. Left arm. | Experimental | Device: Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2)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. |
| Group 2. Right arm. | Active comparator | Procedure: Intravenous cannulation after without prior interventionsHealthy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any gender
- Age at 18-65 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group 1. Left arm. |
| Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle deviceIntradermal 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. | Device | Group 1. Right arm. |
| 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. | Device | Group 2. Left arm. |
| Intravenous cannulation after without prior interventionsinsertion of 18G catheter in a cubital vein without prior interventions. | Procedure or surgery | Group 2. Right arm. |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Derived from this study: PubMed 35100279Rzhevskiy 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.
- Individual participant dataSharing planned: No. The local ethics committee of the Sechenov University does not allow to share IPD; it is possible only upon an official request addressed to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chavdar Dr Pavlov, MD, PhD principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1), Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device and Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2) in people with Local Anaesthesia, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05108714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.