Pain Perception: Lidocaine Rate/Temp/Buffer

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Anesthetic Injection Rate, Temperature and Buffering on Pain Perception During Dermatologic Procedures: a Multicenter, Single-blinded Randomized Control Trial

Conditions
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Pain

Intervention / Treatment
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* Procedure: Slow, Room Temperature Injection
* Procedure: Rapid, Room Temperature Injection
* Procedure: Slow, Warm Temperature Injection
* Procedure: Rapid, Warm Temperature Injection
* Procedure: Buffered Injection
* Procedure: Non-Buffered Injection
* Drug: Lidocaine
* Drug: Buffer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slow, Room Temperature<br>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. | Procedure: Slow, Room Temperature Injection<br>* The room temperature local anesthetic agent will be administered by slow infiltration.<br>Drug: Lidocaine<br>* Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)<br>Drug: Buffer<br>* Sodium Bicarbonate<br>|
| Experimental: Rapid, Room Temperature<br>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. | Procedure: Rapid, Room Temperature Injection<br>* The room temperature local anesthetic agent will be administered by rapid infiltration.<br>Drug: Lidocaine<br>* Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)<br>Drug: Buffer<br>* Sodium Bicarbonate<br>|
| Experimental: Slow, Warmed<br>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. | Procedure: Slow, Warm Temperature Injection<br>* The warmed local anesthetic agent will be administered by slow infiltration.<br>Drug: Lidocaine<br>* Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)<br>Drug: Buffer<br>* Sodium Bicarbonate<br>|
| Experimental: Rapid, Warmed<br>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. | Procedure: Rapid, Warm Temperature Injection<br>* The warmed local anesthetic agent will be administered by rapid infiltration.<br>Drug: Lidocaine<br>* Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)<br>Drug: Buffer<br>* Sodium Bicarbonate<br>|
| Experimental: Buffered<br>In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered. | Procedure: Buffered Injection<br>* 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.<br>Drug: Lidocaine<br>* Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)<br>Drug: Buffer<br>* Sodium Bicarbonate<br>|
| Placebo Comparator: Non-Buffered<br>In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered. | Procedure: Non-Buffered Injection<br>* 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.<br>Drug: Lidocaine<br>* Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | intraoperative |