Reducing Pain of Lidocaine Injection

Duke University

Status and phase: Completed; Phase 4

Conditions: Pain of Anesthesia at Breast Biopsy

Treatments: Drug: 1% Lidocaine plus sodium bicarbonate; Drug: 1% Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02288364

Pro00056728

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

88 participants in 2 patient groups

1% Lidocaine

Active Comparator group

Description:

1% Lidocaine alone.

Treatment:

Drug: 1% Lidocaine

1% Lidocaine plus sodium bicarbonate

Active Comparator group

Description:

1% Lidocaine plus 8.4% sodium bicarbonate

Treatment:

Drug: 1% Lidocaine plus sodium bicarbonate