drugset / Trial / NCT02288364

Reducing Pain of Lidocaine Injection

NCT02288364

Phase 4 Completed 88 enrolled Duke University
RandomizedParallel-groupDouble-blind

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.

Timeline

Start
2014-12
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 1 %
Comparator sodium bicarbonate Diagnostic / imaging agent 8.4 %

Indications

No indication recorded.