Pain Perception: Lidocaine Rate/Temp/Buffer
Status
Active, not recruiting
Conditions
Pain
Treatments
Drug: Buffer
Drug: Lidocaine
Procedure: Slow, Warm Temperature Injection
Procedure: Slow, Room Temperature Injection
Procedure: Non-Buffered Injection
Procedure: Rapid, Warm Temperature Injection
Procedure: Buffered Injection
Procedure: Rapid, Room Temperature Injection
Details and patient eligibility
About
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.
Enrollment
26 patients
Sex
All
Ages
18 to 89 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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 design
Primary purpose
Supportive Care
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
26 participants in 6 patient groups, including a placebo group
Slow, Room Temperature
Experimental group
Description:
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.
Treatment:
Drug: Buffer
Drug: Lidocaine
Procedure: Slow, Room Temperature Injection
Rapid, Room Temperature
Experimental group
Description:
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.
Treatment:
Procedure: Rapid, Room Temperature Injection
Drug: Buffer
Drug: Lidocaine
Slow, Warmed
Experimental group
Description:
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.
Treatment:
Drug: Buffer
Drug: Lidocaine
Procedure: Slow, Warm Temperature Injection
Rapid, Warmed
Experimental group
Description:
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.
Treatment:
Drug: Buffer
Procedure: Rapid, Warm Temperature Injection
Drug: Lidocaine
Buffered
Experimental group
Description:
In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
Treatment:
Drug: Buffer
Drug: Lidocaine
Procedure: Buffered Injection
Non-Buffered
Placebo Comparator group
Description:
In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
Treatment:
Procedure: Non-Buffered Injection
Drug: Lidocaine
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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