Does Sodium Bicarbonate Reduce the Pain of Lidocaine for Local Anesthesia in Percutaneous Breast Biopsies?
Overview
- Phase
- Phase 4
- Intervention
- 1% Lidocaine
- Conditions
- Pain of Anesthesia at Breast Biopsy
- Sponsor
- Duke University
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Pain
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1% Lidocaine
1% Lidocaine alone.
Intervention: 1% Lidocaine
1% Lidocaine plus sodium bicarbonate
1% Lidocaine plus 8.4% sodium bicarbonate
Intervention: 1% Lidocaine plus sodium bicarbonate
Outcomes
Primary Outcomes
Pain
Time Frame: immediately prior to anesthetizing, within approximately 1 minute of starting
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.
Secondary Outcomes
- Pain(immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting)