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Clinical Trials/NCT02288364
NCT02288364
Completed
Phase 4

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

Duke University1 site in 1 country88 target enrollmentDecember 2014

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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