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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% Lidocaine | Active Comparator | 1% Lidocaine alone. |
|
| 1% Lidocaine plus sodium bicarbonate | Active Comparator | 1% Lidocaine plus 8.4% sodium bicarbonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% Lidocaine | Drug |
| ||
| 1% Lidocaine plus sodium bicarbonate |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately prior to anesthetizing, within approximately 1 minute of starting |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately on completion of anesthetizing the skin, within approximately 1 minute of starting |
| Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay A Baker, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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88 participants signed consent. 86 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1% Lidocaine | 1% Lidocaine alone. |
| FG001 | 1% Lidocaine Plus Sodium Bicarbonate | 1% Lidocaine plus 8.4% sodium bicarbonate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1% Lidocaine | 1% Lidocaine alone. |
| BG001 | 1% Lidocaine Plus Sodium Bicarbonate | 1% Lidocaine plus 8.4% sodium bicarbonate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | immediately prior to anesthetizing, within approximately 1 minute of starting |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1% Lidocaine | 1% Lidocaine alone. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jay A. Baker, MD | Duke University Medical Center | 919-684-7645 | jay.baker@duke.edu |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
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.
| immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting |
| 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. | immediately on completion of the biopsy, within approximately 20 minutes of starting |
| 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. | 30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting |
| 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. | immediately prior to injection of "deep" anesthesia in the breast parenchyma, within approximately 4 minutes of starting |
| 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. | 30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting |
| 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. | immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting |
| 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. | immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting |
| 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. | immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | immediately on completion of anesthetizing the skin, within approximately 1 minute of starting |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | immediately on completion of the biopsy, within approximately 20 minutes of starting |
|
|
|
|
| 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. | Data not collected at this time point. | Posted | 30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting |
|
|
| 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. | Data not collected at this time point. | Posted | immediately prior to injection of "deep" anesthesia in the breast parenchyma, within approximately 4 minutes of starting |
|
|
| 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. | Data not collected at this time point. | Posted | 30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting |
|
|
| 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. | Data not collected at this time point. | Posted | immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting |
|
|
| 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. | Data not collected at this time point. | Posted | immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting |
|
|
| 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. | Data not collected at this time point. | Posted | immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting |
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 1% Lidocaine Plus Sodium Bicarbonate | 1% Lidocaine plus 8.4% sodium bicarbonate | 0 | 44 | 0 | 44 |
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| Aniline Compounds |
| D000588 | Amines |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |