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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slow, Room Temperature Injection | Procedure | The room temperature local anesthetic agent will be administered by slow infiltration. |
|
| 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| Pain on a Visual Analog Scale (VAS) | Subjects will rate the pain VAS score immediately after the needle is withdrawn.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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 5, 2025 | |
| Reset | May 20, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 5, 2025 | May 20, 2025 | |||
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000665 | Ampholyte Mixtures |
| D008012 | Lidocaine |
| D002021 | Buffers |
| ID | Term |
|---|---|
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D000083 | Acetanilides |
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| Buffered |
| Experimental |
In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered. |
|
| Non-Buffered | Placebo Comparator | In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered. |
|
| Rapid, Room Temperature Injection | Procedure | The room temperature local anesthetic agent will be administered by rapid infiltration. |
|
| Slow, Warm Temperature Injection | Procedure | The warmed local anesthetic agent will be administered by slow infiltration. |
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| Rapid, Warm Temperature Injection | Procedure | The warmed local anesthetic agent will be administered by rapid infiltration. |
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| Buffered Injection | Procedure | 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. |
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| Non-Buffered Injection | Procedure | 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. |
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| Lidocaine | Drug | Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine) |
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| Buffer | Drug | Sodium Bicarbonate |
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| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |