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NCT02288364 · ClinicalTrials.gov registry record · Phase 4
Reducing Pain of Lidocaine Injection
A Phase 4 study of Pain of Anesthesia at Breast Biopsy, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT02288364: Completed Phase 4 study of Pain of Anesthesia at Breast Biopsy, sponsored by Duke University.
NCT02288364 is a Phase 4 study of Pain of Anesthesia at Breast Biopsy that has completed, run by Duke University. The registered enrollment target is 88 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02288364, a Phase 4 study of Pain of Anesthesia at Breast Biopsy, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 1% Lidocaine
- DRUG 1% Lidocaine plus sodium bicarbonate
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2014-12 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
What the finished NCT02288364 record still lists
NCT02288364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Pain of Anesthesia at Breast Biopsy appearing as the primary indexed condition, and to 2 interventions - of which 1% Lidocaine is the first listed.
NCT02288364 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02288364 about?
NCT02288364 is a clinical study titled "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 approximat...
What is the current status of trial NCT02288364?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2014-12. Estimated completion is 2015-08.
What conditions does trial NCT02288364 study?
This clinical trial studies the following conditions: Pain of Anesthesia at Breast Biopsy.
What interventions are being tested in trial NCT02288364?
The interventions under investigation include: 1% Lidocaine (DRUG), 1% Lidocaine plus sodium bicarbonate (DRUG).
Who is sponsoring clinical trial NCT02288364?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02288364 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02288364's enrollment target sits among peer trials
88 916th of 2000 higher than 1,079 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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