Clinical trial NCT02288364: Reducing Pain of Lidocaine Injection
Official title: Does Sodium Bicarbonate Reduce the Pain of Lidocaine for Local Anesthesia in Percutaneous Breast Biopsies?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain of Anesthesia at Breast Biopsy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 88
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Pain
timeFrame: immediately prior to anesthetizing, within approximately 1 minute of starting
Secondary outcomes:
measure: Pain
timeFrame: immediately on completion of anesthetizing the skin, within approximately 1 minute of starting
measure: Pain
timeFrame: immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting
measure: Pain
timeFrame: immediately on completion of the biopsy, within approximately 20 minutes of starting
measure: Pain
timeFrame: 30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting
measure: Pain
timeFrame: immediately prior to injection of "deep" anesthesia in the breast parenchyma, within approximately 4 minutes of starting
measure: Pain
timeFrame: 30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting
measure: Pain
timeFrame: immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting
measure: Pain
timeFrame: immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting
measure: Pain
timeFrame: immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Jay A Baker, MD
role: PRINCIPAL_INVESTIGATOR
References: