Comparison of Two Lidocaine Administration Techniques

Study Overview
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Brief Summary
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The objective of our study is to determine if technique of lidocaine administration can decrease pain perception. Hypothesis: There will be a significant difference in pain perception between patients who are given lidocaine on the skin surface prior to subcutaneous injection and patients who are given only subcutaneous injection by standard approach.

Detailed Description
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This is a single center prospective, randomized, blinded study assessing pain perception following 2 different lidocaine administration techniques in subjects who have planned medical procedures requiring local injection of lidocaine. Subjects will be approached and consented to participate in the study. They will be interviewed after the scheduled medical procedure to assess their pain using validated pain scores. An investigator who is not present for the procedure and blinded to the randomization will gather data regarding perceptions of pain from the entire procedure.

Official Title
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Comparison of Two Lidocaine Administration Techniques

Conditions
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Pain

Intervention / Treatment
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* Drug: lidocaine
* Drug: lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients refered to the University of Chicago Medical Centers Procedure Service for a planned medical procedure requiring local injection of lidocaine. Exclusion Criteria: Patient who lack decisional capacity to consent Patients who lack the ability to answer questions in english using pain scales

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine onto skin prior to lidocaine subcutaneous injection<br>1-2ml of 1% lidocaine dripped onto the surface of the skin immediately prior to subcutaneous injection of 1% lidocaine. | Drug: lidocaine<br>* 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection<br>|
| Active Comparator: lidocaine subcutaneous injection alone<br>1% lidocaine subcutaneous injection alone by standard approach | Drug: lidocaine<br>* 1% lidocaine subcutaneous injection alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment: Overall | Visual analog scale (VAS). This is a standardized analog scale with scores from 0-100. It measures level of pain with 0 meaning no pain and 100 meaning the most extreme level of pain. Higher values refer to a worse outcome. | post procedure (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment: Lidocaine Injection | visual analog scale (VAS) 0= no pain to 100 = worse pain possible | post procedure (day 1) | 
| Pain Assessment: During Procedure | visual analog scale (VAS) 0 = no pain to 100 = worse pain possible Rather, this is a pain assessment during the actual procedure rather than during the pre-procedure lidocaine injection. | post procedure (day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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procedural