Reducing Pain of Lidocaine Injection

Study Overview
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Brief Summary
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The purpose of this study is to determine the benefit, if any, of buffering lidocaine (adding sodium bicarbonate) when used for local anesthesia prior to percutaneous breast needle core biopsies. The medicine doctors use to reduce the pain of breast biopsies, lidocaine, can cause pain for approximately 15 seconds until the numbing effect begins. It is possible that this pain is caused because lidocaine is acidic. Some physicians believe that reducing the acidity of lidocaine by mixing it with sodium bicarbonate will reduce the initial pain of injecting the lidocaine. Both approaches - injecting 1% lidocaine alone and injecting 1% lidocaine mixed with sodium bicarbonate - are used as routine standard of care by radiologists today. The purpose of this study is to determine if either approach is more comfortable for patients having breast procedures.

Official Title
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Does Sodium Bicarbonate Reduce the Pain of Lidocaine for Local Anesthesia in Percutaneous Breast Biopsies?

Conditions
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Pain of Anesthesia at Breast Biopsy

Intervention / Treatment
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* Drug: 1% Lidocaine
* Drug: 1% Lidocaine plus sodium bicarbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 Years of age Any patient scheduled for a breast biopsy at Duke Breast Interventional Imaging Exclusion Criteria: Less than 21 Years of age Allergic to Lidocaine or Sodium Bicarbonate Not mentally capable of consenting

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1% Lidocaine<br>1% Lidocaine alone. | Drug: 1% Lidocaine<br> <br> |
| Active Comparator: 1% Lidocaine plus sodium bicarbonate<br>1% Lidocaine plus 8.4% sodium bicarbonate | Drug: 1% Lidocaine plus sodium bicarbonate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible. | immediately prior to anesthetizing, within approximately 1 minute of starting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible. | immediately on completion of anesthetizing the skin, within approximately 1 minute of starting | 
| Pain | Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible. | immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting | 
| Pain | Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible. | immediately on completion of the biopsy, within approximately 20 minutes of starting | 
| Pain | Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible. | 30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting | 
| Pain | Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible. | immediately prior to injection of deep anesthesia in the breast parenchyma, within approximately 4 minutes of starting | 
| Pain | Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible. | 30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting | 
| Pain | Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible. | immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting | 
| Pain | Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible. | immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting | 
| Pain | Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible. | immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting |