Phase 4
Completed N=86
Reducing Pain of Lidocaine Injection
Pain of Anesthesia at Breast Biopsy
Source: ClinicalTrials.gov NCT02288364 ↗
Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Pain — 1.19; 0.56 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain |
— | — |
| SECONDARY Pain |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02288364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.