Local InfiltrationPhase 2NCT03238625
Painless Local Anaesthesia With Bicarbonate Admixture
A Phase 2 study testing Lidocaine and sodium bicarbonate, Lidocaine and Sodium cloride 0.9% in people with Local Infiltration and Anesthesia, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study examines whether the injection of local anesthesia mixed with sodium bicarbonate in the ratio of 3:1 creates a less burning sensation and is as effective regarding the anesthetic effect as in the ratio of 9:1. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Infiltration, Anesthesia
- What is being tested?
- Lidocaine and sodium bicarbonate, Lidocaine and Sodium cloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2017to 18 Oct 2017
- Phase
- Phase 2
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male or female individuals between 18 and 75 years
- able to understand and speak German
- able to follow the instructions
Who cannot join
- oversensitivity to lidocaine or other local anesthetics of amide type or sulfites
- prone to bleeding, intake of aspirine or anticoagulation
- pregnancy
- skin on forearms with lesions (i.e. sunburn, wounds, eczema or other skin diseases)
- previous participation at the same study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University hospital, Department of Dermatology
Zurich, Canton of Zurich, 8091
About this study
Official title: Painless Local Anaesthesia With Bicarbonate Admixture: A Phase II, Monocentric, Double-blind, Randomized, Placebo-controlled Crossover Trial
This study examines whether the injection of local anesthesia mixed with sodium bicarbonate in the ratio of 3:1 creates a less burning sensation and is as effective regarding the anesthetic effect as in the ratio of 9:1.
Read the detailed description
Therefore the investigators compare two groups with 24 healthy individuals in each group in a cross-over study. One group receives four injections (two in each forearm) and one group receives only two injections (one in each forearm)
The four injections of group 1 are:
- IMP1: Lidocaine and sodium bicarbonate ratio 3:1
- IMP 2: Lidocaine and sodium bicarbonate ratio 9:1
- IMP 3: Lidocaine
- IMP 4: Sodium cloride 0.9% (=placebo)
The two injections of group 2 are IMP1 and IMP2.
After each injection the individual has to rate their pain sensation on a NRS scale and afterwards the anesthetic effect gets tested by a standardized laser application.
- Conditions
- Local Infiltration, Anesthesia
- Being tested
- Lidocaine and sodium bicarbonate, Lidocaine, Sodium cloride 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine and sodium bicarbonateDrug
Lidocaine and sodium bicarbonate ratio 3:1
Lidocaine and sodium bicarbonateDrug
Lidocaine and sodium bicarbonate ratio 9:1
LidocaineDrug
Lidocaine injection
Sodium cloride 0.9%Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Consisting of 24 individuals between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine.
Intervention: Every individual receives four injections IMP1: Lidocaine and sodium bicarbonate ratio 3:1, IMP 2: Lidocaine and sodium bicarbonate ratio 9:1, IMP 3: Lidocaine, and IMP 4: Sodium cloride 0.9% (=placebo), namely two in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the four areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes. Receives: Drug: Lidocaine and sodium bicarbonate; Drug: Lidocaine; Drug: Sodium cloride 0.9% |
| Group 2 | Placebo comparator | Consisting of 24 different individuals than those belonging to Group 1. Between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine.
Intervention: Every individual receives two injections:
IMP 3 Lidocaine, and IMP 4 Sodium cloride 0.9% (=placebo), namely one in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the two areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes. Receives: Drug: Lidocaine; Drug: Sodium cloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of injection pain between IMP1 and IMP2
on NRS scale
Measured: 1 minute
Secondary outcomes (4)
rating of injection pain of IMP3 and IMP4
on NRS scale
Measured: 1 minute
rating of clinical relevance of the difference between pain sensation of the injections
participant can choose between four adjectives regarding injection pain:
- desirable
- acceptable
- less acceptable
- unacceptable
Measured: 5 minutes
assessment of local anesthesia of each injection with a standardized laser
with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms
Measured: 90 minutes
duration of anesthetic effect of each injection
with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms
Measured: maximum 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Aug 2017
- Primary completion18 Oct 2017
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local InfiltrationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238625
- Sponsor's protocol ID
- LIDOBICARB
- Status last verified
- Dec 2017
- First submitted
- 21 Jun 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Painless Local Anaesthesia With Bicarbonate Admixture: A Phase II, Monocentric, Double-blind, Randomized, Placebo-controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT03238625
- Acronym / sponsor ID
- LIDOBICARB
- Conditions
- Local Infiltration, Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 3 Aug 2017 (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.
This study examines whether the injection of local anesthesia mixed with sodium bicarbonate in the ratio of 3:1 creates a less burning sensation and is as effective regarding the anesthetic effect as in the ratio of 9:1.
Detailed description
Therefore the investigators compare two groups with 24 healthy individuals in each group in a cross-over study. One group receives four injections (two in each forearm) and one group receives only two injections (one in each forearm)
The four injections of group 1 are:
- IMP1: Lidocaine and sodium bicarbonate ratio 3:1
- IMP 2: Lidocaine and sodium bicarbonate ratio 9:1
- IMP 3: Lidocaine
- IMP 4: Sodium cloride 0.9% (=placebo)
The two injections of group 2 are IMP1 and IMP2.
After each injection the individual has to rate their pain sensation on a NRS scale and afterwards the anesthetic effect gets tested by a standardized laser application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Lidocaine and sodium bicarbonate, Drug: Lidocaine, Drug: Sodium cloride 0.9%Consisting of 24 individuals between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine. Intervention: Every individual receives four injections IMP1: Lidocaine and sodium bicarbonate ratio 3:1, IMP 2: Lidocaine and sodium bicarbonate ratio 9:1, IMP 3: Lidocaine, and IMP 4: Sodium cloride 0.9% (=placebo), namely two in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the four areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes. |
| Group 2 | Placebo comparator | Drug: Lidocaine, Drug: Sodium cloride 0.9%Consisting of 24 different individuals than those belonging to Group 1. Between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine. Intervention: Every individual receives two injections: IMP 3 Lidocaine, and IMP 4 Sodium cloride 0.9% (=placebo), namely one in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the two areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy male or female individuals between 18 and 75 years
- able to understand and speak German
- able to follow the instructions
Key exclusion criteria (5 listed)
- oversensitivity to lidocaine or other local anesthetics of amide type or sulfites
- prone to bleeding, intake of aspirine or anticoagulation
- pregnancy
- skin on forearms with lesions (i.e. sunburn, wounds, eczema or other skin diseases)
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 |
|---|---|---|
| Lidocaine and sodium bicarbonateLidocaine and sodium bicarbonate ratio 3:1 | Drug | Group 1 |
| Lidocaine and sodium bicarbonateLidocaine and sodium bicarbonate ratio 9:1 | Drug | Group 1 |
| LidocaineLidocaine injection | Drug | Group 1, Group 2 |
| Sodium cloride 0.9%Placebo | Drug | Group 1, Group 2 |
Primary outcome
Rating of injection pain between IMP1 and IMP2
Time frame: 1 minute
on NRS scale
4 secondary outcomes
rating of injection pain of IMP3 and IMP4
Time frame: 1 minute
rating of clinical relevance of the difference between pain sensation of the injections
Time frame: 5 minutes
assessment of local anesthesia of each injection with a standardized laser
Time frame: 90 minutes
duration of anesthetic effect of each injection
Time frame: maximum 90 minutes
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 21 Dec 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine and sodium bicarbonate, Lidocaine and Sodium cloride 0.9% in people with Local Infiltration and Anesthesia, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 5 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 21 Dec 2017. 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 Switzerland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rating of injection pain between IMP1 and IMP2 (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2017.