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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
88
Duke University Medical Center
Durham, North Carolina, United States
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.
Time frame: immediately prior to anesthetizing, 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting
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