PainNCT02823002
Pain Perception: Lidocaine Rate/Temp/Buffer
A study testing Slow, Room Temperature Injection, Rapid, Room Temperature Injection and Slow, Warm Temperature Injection in people with Pain, run by Northwestern University at 1 site in United States.
Trial summary
This study will collect data from multiple academic institutions. The primary objective for part A of this study is to determine the impact of anesthetic injection rate and temperature on pain perception during dermatologic procedures, and the objective for the part B of this study is to determine if buffering of the… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Slow, Room Temperature Injection, Rapid, Room Temperature Injection and Slow, Warm Temperature Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jan 2025
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who are undergoing dermatologic procedures.
- Subjects ages 18-89 year old.
- The subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.
Who cannot join
- Subjects who are allergic to lidocaine.
- History of bleeding tendency or coagulopathy.
- Pregnant or lactating.
- Active skin disease or skin infection in the treatment area.
- Unable to understand the protocol or give informed consent.
- Any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: The Impact of Anesthetic Injection Rate, Temperature and Buffering on Pain Perception During Dermatologic Procedures: a Multicenter, Single-blinded Randomized Control Trial
This study will collect data from multiple academic institutions. The primary objective for part A of this study is to determine the impact of anesthetic injection rate and temperature on pain perception during dermatologic procedures, and the objective for the part B of this study is to determine if buffering of the anesthetic solution alters pain perception.
This study is a pilot study designed to determine feasibility of these procedures.
- Conditions
- Pain
- Being tested
- Slow, Room Temperature Injection, Rapid, Room Temperature Injection, Slow, Warm Temperature Injection, Rapid, Warm Temperature Injection, Buffered Injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow, Room Temperature InjectionProcedure or surgery
The room temperature local anesthetic agent will be administered by slow infiltration.
Rapid, Room Temperature InjectionProcedure or surgery
The room temperature local anesthetic agent will be administered by rapid infiltration.
Slow, Warm Temperature InjectionProcedure or surgery
The warmed local anesthetic agent will be administered by slow infiltration.
Rapid, Warm Temperature InjectionProcedure or surgery
The warmed local anesthetic agent will be administered by rapid infiltration.
Buffered InjectionProcedure or surgery
One side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent.
Non-Buffered InjectionProcedure or surgery
One side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent.
LidocaineDrug
Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)
BufferDrug
Sodium Bicarbonate
| Study group | Role | What they receive |
|---|---|---|
| Slow, Room Temperature | Experimental | In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature. Receives: Procedure: Slow, Room Temperature Injection; Drug: Lidocaine; Drug: Buffer |
| Rapid, Room Temperature | Experimental | In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature. Receives: Procedure: Rapid, Room Temperature Injection; Drug: Lidocaine; Drug: Buffer |
| Slow, Warmed | Experimental | In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature. Receives: Procedure: Slow, Warm Temperature Injection; Drug: Lidocaine; Drug: Buffer |
| Rapid, Warmed | Experimental | In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature. Receives: Procedure: Rapid, Warm Temperature Injection; Drug: Lidocaine; Drug: Buffer |
| Buffered | Experimental | In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered. Receives: Procedure: Buffered Injection; Drug: Lidocaine; Drug: Buffer |
| Non-Buffered | Placebo comparator | In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered. Receives: Procedure: Non-Buffered Injection; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on a Visual Analog Scale (VAS)
Subjects will rate the pain VAS score immediately after the needle is withdrawn. They will be asked to rate the pain of the injection of the solution. VAS pain scale is rated on a 10 cm scale with 0 cm being no pain and 10 cm being extremely painful.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823002
- Sponsor's protocol ID
- STU00202894
- Status last verified
- Mar 2024
- First submitted
- 27 Jun 2016
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Anesthetic Injection Rate, Temperature and Buffering on Pain Perception During Dermatologic Procedures: a Multicenter, Single-blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02823002
- Acronym / sponsor ID
- STU00202894
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 6 Jul 2016 (estimated)
- 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 will collect data from multiple academic institutions. The primary objective for part A of this study is to determine the impact of anesthetic injection rate and temperature on pain perception during dermatologic procedures, and the objective for the part B of this study is to determine if buffering of the anesthetic solution alters pain perception.
This study is a pilot study designed to determine feasibility of these procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Slow, Room Temperature | Experimental | Procedure: Slow, Room Temperature Injection, Drug: Lidocaine, Drug: BufferIn Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature. |
| Rapid, Room Temperature | Experimental | Procedure: Rapid, Room Temperature Injection, Drug: Lidocaine, Drug: BufferIn Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature. |
| Slow, Warmed | Experimental | Procedure: Slow, Warm Temperature Injection, Drug: Lidocaine, Drug: BufferIn Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature. |
| Rapid, Warmed | Experimental | Procedure: Rapid, Warm Temperature Injection, Drug: Lidocaine, Drug: BufferIn Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature. |
| Buffered | Experimental | Procedure: Buffered Injection, Drug: Lidocaine, Drug: BufferIn Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered. |
| Non-Buffered | Placebo comparator | Procedure: Non-Buffered Injection, Drug: LidocaineIn Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who are undergoing dermatologic procedures.
- Subjects ages 18-89 year old.
- The subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.
Key exclusion criteria (6 listed)
- Subjects who are allergic to lidocaine.
- History of bleeding tendency or coagulopathy.
- Pregnant or lactating.
- Active skin disease or skin infection in the treatment area.
- Unable to understand the protocol or give informed consent.
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 |
|---|---|---|
| Slow, Room Temperature InjectionThe room temperature local anesthetic agent will be administered by slow infiltration. | Procedure or surgery | Slow, Room Temperature |
| Rapid, Room Temperature InjectionThe room temperature local anesthetic agent will be administered by rapid infiltration. | Procedure or surgery | Rapid, Room Temperature |
| Slow, Warm Temperature InjectionThe warmed local anesthetic agent will be administered by slow infiltration. | Procedure or surgery | Slow, Warmed |
| Rapid, Warm Temperature InjectionThe warmed local anesthetic agent will be administered by rapid infiltration. | Procedure or surgery | Rapid, Warmed |
| Buffered InjectionOne side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent. | Procedure or surgery | Buffered |
| Non-Buffered InjectionOne side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent. | Procedure or surgery | Non-Buffered |
| LidocaineInjectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine) | Drug | Buffered, Non-Buffered, Rapid, Room Temperature, Rapid, Warmed, Slow, Room Temperature, Slow, Warmed |
| BufferSodium Bicarbonate | Drug | Buffered, Rapid, Room Temperature, Rapid, Warmed, Slow, Room Temperature, Slow, Warmed |
Primary outcome
Pain on a Visual Analog Scale (VAS)
Time frame: intraoperative
Subjects will rate the pain VAS score immediately after the needle is withdrawn. They will be asked to rate the pain of the injection of the solution. VAS pain scale is rated on a 10 cm scale with 0 cm being no pain and 10 cm being extremely painful.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Murad Alam, MD principal investigator
Northwestern 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 Slow, Room Temperature Injection, Rapid, Room Temperature Injection and Slow, Warm Temperature Injection in people with Pain, run by Northwestern University at 1 site in United States.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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 United States. 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?
Results are not available in the source record.
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 on a Visual Analog Scale (VAS) (time frame: intraoperative). 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 15 Mar 2024.