Effectiveness Study of Different Local Anesthetic Mixtures (CA)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: 1% Lidocaine with Epinephrine (1:100,000); Drug: 0.25% Bupivacaine with Epinephrine (1:200,000); Drug: 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000); Drug: 1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)	Phase 4

Detailed Description:

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Basic Science
Official Title:	Onset and Duration of Effect of Lidocaine, Bupivacaine, and Lidocaine/Bupivacaine Mixture With Epinephrine.
Study Start Date :	May 2010
Actual Primary Completion Date :	September 2010
Actual Study Completion Date :	September 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Lidocaine w/ Epi; 0.2ml 1% Lidocaine with Epinephrine (1:100,000)	Drug: 1% Lidocaine with Epinephrine (1:100,000); 0.2ml Intradermal injection once.
Experimental: Bupivacaine with epi; 0.2 ml 0.25% Bupivacaine with epinephrine (1:200,000)	Drug: 0.25% Bupivacaine with Epinephrine (1:200,000); 0.2ml Intradermal injection once.
Experimental: Low dose Lido and Bupi w/ Epi; 0.2ml 0.5% Lidocaine + 0.125% Bupivacaine with Epinephrine (1:150,000)	Drug: 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000); 0.2ml Intradermal injection once.
Experimental: High Dose Lido and Bupi with epi; 0.2ml 1% Lidocaine + 0.25% Bupivacaine with Epinephrine (1:150,000)	Drug: 1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000); 0.2ml Intradermal injection once.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Length of Action [ Time Frame: Up to 12 hours ]
   The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.
2. Onset of Action [ Time Frame: Up to 5 minutes ]
   Time from infusion of local anesthetic to loss of sensation to sharp.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Age: 18-60

Exclusion Criteria:

• Pregnancy
• allergy to local anesthetics
• history of heart disease or diabetes

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Texas
Scott & White
Temple, Texas, United States, 76504

Sponsors and Collaborators

Scott and White Hospital & Clinic

Investigators

Principal Investigator:	James B Collins, MD	Scott and White Healthcare
Study Director:	Raman C Mahabir, MD	Scott and White Healthcare

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	James Collins, MD, Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:	NCT01243112 History of Changes
Other Study ID Numbers:	090520
First Posted:	November 18, 2010
Results First Posted:	December 2, 2011
Last Update Posted:	December 2, 2011
Last Verified:	October 2011

Additional relevant MeSH terms:

Bupivacaine; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers	Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Sympathomimetics; Vasoconstrictor Agents