Pain of Anesthesia at Breast BiopsyPhase 4NCT02288364

Reducing Pain of Lidocaine Injection

A Phase 4 study testing 1% Lidocaine and 1% Lidocaine plus sodium bicarbonate in people with Pain of Anesthesia at Breast Biopsy, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 89 years
Conditions the study is for: Pain of Anesthesia at Breast Biopsy
What is being tested?: 1% Lidocaine and 1% Lidocaine plus sodium bicarbonate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteUnited States
Study dates: Dec 2014to Aug 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

21 Years of age
Any patient scheduled for a breast biopsy at Duke Breast Interventional Imaging

Who cannot join

Less than 21 Years of age
Allergic to Lidocaine or Sodium Bicarbonate
Not mentally capable of consenting

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Does Sodium Bicarbonate Reduce the Pain of Lidocaine for Local Anesthesia in Percutaneous Breast Biopsies?

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.

Conditions: Pain of Anesthesia at Breast Biopsy
Being tested: 1% Lidocaine, 1% Lidocaine plus sodium bicarbonate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1% LidocaineDrug
1% Lidocaine plus sodium bicarbonateDrug

Study groups in NCT02288364
Study group	Role	What they receive
1% Lidocaine	Active comparator	1% Lidocaine alone. Receives: Drug: 1% Lidocaine
1% Lidocaine plus sodium bicarbonate	Active comparator	1% Lidocaine plus 8.4% sodium bicarbonate Receives: Drug: 1% Lidocaine plus sodium bicarbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: immediately prior to anesthetizing, within approximately 1 minute of starting

Secondary outcomes (9)

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.
Measured: immediately on completion of anesthetizing the skin, 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Aug 2015

First posted11 Nov 2014 (estimated)
Study startDec 2014
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain of Anesthesia at Breast BiopsyStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02288364
Sponsor's protocol ID: Pro00056728
Status last verified: Feb 2016
First submitted: 13 Oct 2014
Last updated: 15 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Sodium Bicarbonate Reduce the Pain of Lidocaine for Local Anesthesia in Percutaneous Breast Biopsies?
ClinicalTrials.gov ID: NCT02288364
Acronym / sponsor ID: Pro00056728
Conditions: Pain of Anesthesia at Breast Biopsy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Dec 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 11 Nov 2014 (estimated)
Results: Posted 14 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1% Lidocaine	Active comparator	Drug: 1% Lidocaine1% Lidocaine alone.
1% Lidocaine plus sodium bicarbonate	Active comparator	Drug: 1% Lidocaine plus sodium bicarbonate1% Lidocaine plus 8.4% sodium bicarbonate

Who may qualify

Ages: 21 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

21 Years of age
Any patient scheduled for a breast biopsy at Duke Breast Interventional Imaging

Key exclusion criteria (3 listed)

Less than 21 Years of age
Allergic to Lidocaine or Sodium Bicarbonate
Not mentally capable of consenting

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1% Lidocaine	Drug	1% Lidocaine
1% Lidocaine plus sodium bicarbonate	Drug	1% Lidocaine plus sodium bicarbonate

Primary outcome

Pain
Time frame: 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.

9 secondary outcomes

Pain
Time frame: immediately on completion of anesthetizing the skin, within approximately 1 minute of starting
Pain
Time frame: immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting
Pain
Time frame: immediately on completion of the biopsy, within approximately 20 minutes of starting
Pain
Time frame: 30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting
Pain
Time frame: immediately prior to injection of "deep" anesthesia in the breast parenchyma, within approximately 4 minutes of starting
Pain
Time frame: 30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting
Pain
Time frame: immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting
Pain
Time frame: immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting
Pain
Time frame: immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting

Results and safety

Results posted to the registry on 14 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1% Lidocaine	42	42
1% Lidocaine Plus Sodium Bicarbonate	44	44

Primary outcome: Pain

Time frame: immediately prior to anesthetizing, within approximately 1 minute of starting. Mean (Standard Deviation). Unit: units on a scale

Measure	1% Lidocaine n = 42	1% Lidocaine Plus Sodium Bicarbonate n = 44
Value	1.19 (1.92)	0.56 (1.30)

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1% Lidocaine	0 of 42 (0%)	0 of 42 (0%)	Not reported
1% Lidocaine Plus Sodium Bicarbonate	0 of 44 (0%)	0 of 44 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jay A Baker, MD principal investigator

Duke Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 1% Lidocaine and 1% Lidocaine plus sodium bicarbonate in people with Pain of Anesthesia at Breast Biopsy, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (time frame: immediately prior to anesthetizing, within approximately 1 minute of starting). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02288364.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.