Reducing Pain of Lidocaine Injection

Phase 4

Completed

• Conditions: Pain of Anesthesia at Breast Biopsy
• Interventions: Drug: 1% Lidocaine plus sodium bicarbonate; Drug: 1% Lidocaine

• Registration Number: NCT02288364
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-11
• Study Start: 2014-12
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-02
• Results First Submitted: 2016-02-16
• Results First Submitted QC: 2016-02-16
• Results First Posted: 2016-03-14
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• 21 Years of age
• Any patient scheduled for a breast biopsy at Duke Breast Interventional Imaging

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Exclusion Criteria

• Less than 21 Years of age
• Allergic to Lidocaine or Sodium Bicarbonate
• Not mentally capable of consenting

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% Lidocaine plus sodium bicarbonate	1% Lidocaine plus sodium bicarbonate	1% Lidocaine plus 8.4% sodium bicarbonate
1% Lidocaine	1% Lidocaine	1% Lidocaine alone.

Primary Outcome Measures

Name	Time	Method
Pain	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 Outcome Measures

Name	Time	Method
Pain	immediately on completion of the final core biopsy specimen, within approximately 20 minutes 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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States