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Effectiveness Study of Different Local Anesthetic Mixtures

NCT ID: NCT01243112

Last Updated: 2011-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-09-30

Brief Summary

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Purpose and Background The purpose of this research study is to investigate the benefits of mixing lidocaine and bupivacaine for numbing the skin. Lidocaine and bupivacaine are two commonly used medications to numb the skin for minor procedures. Lidocaine has a faster onset. Bupivacaine has a longer duration. They are often combined with epinephrine to increase the length of action. These medications are used to control pain at the time of the operation and to decrease discomfort immediately afterward. Participating in the study involves injection of local anesthetic containing lidocaine, bupivacaine, and lidocaine and bupivacain with epinephrine at 4 sites on the forearm. Your participation will potentially improve the administration of these medications in persons undergoing a variety of procedures. You will be one of approximately 25 healthy volunteer subjects in this research study.

Detailed Description

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Procedures

During your participation the following procedures will be completed:

* You will be asked to read over and sign this consent form, if you choose to participate
* You will be asked demographic information and your medical history will be obtained
* If you are eligible to participate, the palm side of your forearm will be marked for the location of the treatments
* Four small injections will be made into the palm side of your forearms with the local anesthetic mixtures (you will not know which injection is used at each of the four injection sites)
* A small needle will be used for pinprick sensation to determine when numbness begins and ends

Length of Study and Number of Visits This study begins at the time the medications are injected and is completed when sensation has completely returned. The study will last between 6 and 12 hours. During this time, you may perform low intensity tasks including reading, typing, and writing. You must remain in the study location as the sites will frequently be examined.

Exclusions

You should not participate in this study if any of the following apply to you:

* You are pregnant
* You have an allergy to lidocaine or bupivacaine
* You have a history of heart disease (including a prior heart attack, heart dysfunction, or heart failure)

There may be other criteria that you have to meet to be eligible for this study. The study team can discuss these with you to determine whether you qualify.

Discomfort and Risks Risks associated with the injections include temporary discomfort at the injection site and possible infection. It is also possible that you have an allergic reaction or side effect to the medications that are being used.

Benefits There is no direct benefit to you for participating in this study. Your participation will potentially improve the administration of these medications in persons undergoing a variety of procedures.

Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lidocaine w/ Epi

0.2ml 1% Lidocaine with Epinephrine (1:100,000)

Group Type EXPERIMENTAL

1% Lidocaine with Epinephrine (1:100,000)

Intervention Type DRUG

0.2ml Intradermal injection once.

Bupivacaine with epi

0.2 ml 0.25% Bupivacaine with epinephrine (1:200,000)

Group Type EXPERIMENTAL

0.25% Bupivacaine with Epinephrine (1:200,000)

Intervention Type DRUG

0.2ml Intradermal injection once.

Low dose Lido and Bupi w/ Epi

0.2ml 0.5% Lidocaine + 0.125% Bupivacaine with Epinephrine (1:150,000)

Group Type EXPERIMENTAL

0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000)

Intervention Type DRUG

0.2ml Intradermal injection once.

High Dose Lido and Bupi with epi

0.2ml 1% Lidocaine + 0.25% Bupivacaine with Epinephrine (1:150,000)

Group Type EXPERIMENTAL

1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)

Intervention Type DRUG

0.2ml Intradermal injection once.

Interventions

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1% Lidocaine with Epinephrine (1:100,000)

0.2ml Intradermal injection once.

Intervention Type DRUG

0.25% Bupivacaine with Epinephrine (1:200,000)

0.2ml Intradermal injection once.

Intervention Type DRUG

0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000)

0.2ml Intradermal injection once.

Intervention Type DRUG

1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)

0.2ml Intradermal injection once.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age: 18-60

Exclusion Criteria

* Pregnancy
* allergy to local anesthetics
* history of heart disease or diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scott and White Hospital & Clinic

OTHER

Sponsor Role lead

Responsible Party

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James Collins

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James B Collins, MD

Role: PRINCIPAL_INVESTIGATOR

Scott and White Healthcare

Raman C Mahabir, MD

Role: STUDY_DIRECTOR

Scott and White Healthcare

Locations

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Scott & White

Temple, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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090520

Identifier Type: -

Identifier Source: org_study_id