Effectiveness Study of Different Local Anesthetic Mixtures
Condition: Pain
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): 1% Lidocaine with Epinephrine (1:100,000); 0.25% Bupivacaine with Epinephrine (1:200,000); 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000); 1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.2ml Intradermal injection once.; 0.2ml Intradermal injection once.; 0.2ml Intradermal injection once.; 0.2ml Intradermal injection once.
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science