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Reducing Pain of Lidocaine Injection

NCT ID: NCT02288364

Last Updated: 2016-04-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Pain of Anesthesia at Breast Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1% Lidocaine

1% Lidocaine alone.

Group Type ACTIVE_COMPARATOR

1% Lidocaine

Intervention Type DRUG

1% Lidocaine plus sodium bicarbonate

1% Lidocaine plus 8.4% sodium bicarbonate

Group Type ACTIVE_COMPARATOR

1% Lidocaine plus sodium bicarbonate

Intervention Type DRUG

Interventions

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1% Lidocaine

Intervention Type DRUG

1% Lidocaine plus sodium bicarbonate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jay A Baker, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00056728

Identifier Type: -

Identifier Source: org_study_id

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