Pain of Anesthesia at Breast Biopsy
Conditions
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.
Interventions
DRUG1% Lidocaine
DRUG1% Lidocaine plus sodium bicarbonate
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pain | 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. |
Countries
United States
Participant flow
Recruitment details
88 participants signed consent. 86 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 1% Lidocaine 1% Lidocaine alone. | 42 |
| 1% Lidocaine Plus Sodium Bicarbonate 1% Lidocaine plus 8.4% sodium bicarbonate | 44 |
| Total | 86 |
Baseline characteristics
| Characteristic | 1% Lidocaine | 1% Lidocaine Plus Sodium Bicarbonate | Total |
|---|---|---|---|
| Age, Continuous | 53.26 years STANDARD_DEVIATION 13.7 | 53.80 years STANDARD_DEVIATION 13.22 | 53.53 years STANDARD_DEVIATION 13.38 |
| Race/Ethnicity, Customized Asian | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Black | 11 participants | 13 participants | 24 participants |
| Race/Ethnicity, Customized Other | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 28 participants | 31 participants | 59 participants |
| Region of Enrollment United States | 42 participants | 44 participants | 86 participants |
| Sex: Female, Male Female | 42 Participants | 44 Participants | 86 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 44 |
| serious Total, serious adverse events | 0 / 42 | 0 / 44 |
Outcome results
Primary
Pain
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.
Time frame: immediately prior to anesthetizing, within approximately 1 minute of starting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Lidocaine | Pain | 1.19 units on a scale | Standard Deviation 1.92 |
| 1% Lidocaine Plus Sodium Bicarbonate | Pain | 0.56 units on a scale | Standard Deviation 1.3 |
Secondary
Pain
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.
Time frame: immediately on completion of anesthetizing the skin, within approximately 1 minute of starting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Lidocaine | Pain | 2.07 units on a scale | Standard Deviation 2.05 |
| 1% Lidocaine Plus Sodium Bicarbonate | Pain | 1.61 units on a scale | Standard Deviation 1.99 |
p-value: 0.3Chi-squared
Secondary
Pain
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.
Time frame: immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Lidocaine | Pain | 2.98 units on a scale | Standard Deviation 2.67 |
| 1% Lidocaine Plus Sodium Bicarbonate | Pain | 2.02 units on a scale | Standard Deviation 2.37 |
p-value: 0.08Chi-squared
Secondary
Pain
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.
Time frame: immediately on completion of the biopsy, within approximately 20 minutes of starting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Lidocaine | Pain | 1.45 units on a scale | Standard Deviation 2.65 |
| 1% Lidocaine Plus Sodium Bicarbonate | Pain | 0.91 units on a scale | Standard Deviation 2.06 |
p-value: 0.29Chi-squared
Secondary
Pain
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.
Time frame: 30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting
Population: Data not collected at this time point.
Secondary
Pain
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.
Time frame: immediately prior to injection of deep anesthesia in the breast parenchyma, within approximately 4 minutes of starting
Population: Data not collected at this time point.
Secondary
Pain
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.
Time frame: 30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting
Population: Data not collected at this time point.
Secondary
Pain
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.
Time frame: immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting
Population: Data not collected at this time point.
Secondary
Pain
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.
Time frame: immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting
Population: Data not collected at this time point.
Secondary
Pain
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.
Time frame: immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting
Population: Data not collected at this time point.