Reducing Pain of Lidocaine Injection

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.

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Key information

Conditions

Pain of Anesthesia at Breast Biopsy

Age range

21 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1% Lidocaine

Drug

1% Lidocaine plus sodium bicarbonate

Drug

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

Time frame: immediately on completion of anesthetizing the skin, 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.
Pain

Time frame: immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 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.
Pain

Time frame: immediately on completion of the biopsy, 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.
Pain

Time frame: 30 seconds after initiating superficial injection in the subcutaneous tissue, 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.
Pain

Time frame: immediately prior to injection of "deep" anesthesia in the breast parenchyma, within approximately 4 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.
Pain

Time frame: 30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 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.
Pain

Time frame: immediately prior to obtaining the first core biopsy specimen, within approximately 15 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.
Pain

Time frame: immediately after obtaining the first core biopsy specimen, within approximately 15 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.
Pain

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 11, 2014
Registry last updated: Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.