Pain
Conditions
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.
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.
Interventions
DRUG1% Lidocaine with Epinephrine (1:100,000)
0.2ml Intradermal injection once.
DRUG0.25% Bupivacaine with Epinephrine (1:200,000)
0.2ml Intradermal injection once.
DRUG0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000)
0.2ml Intradermal injection once.
DRUG1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)
0.2ml Intradermal injection once.
Sponsors
Scott and White Hospital & Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18-60
Exclusion criteria
* Pregnancy * allergy to local anesthetics * history of heart disease or diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Action | Up to 12 hours | The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments. |
| Onset of Action | Up to 5 minutes | Time from infusion of local anesthetic to loss of sensation to sharp. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited by hospital mailing list with 25 subjects enrolled over May 2010 until September 2010.
Participants by arm
| Arm | Count |
|---|---|
| Study Group 0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000) | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Study Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age Continuous | 36 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Length of Action
The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.
Time frame: Up to 12 hours
Population: A calculation was made to power the study appropriately to determine a difference of 5 minutes based on previous studies which did not include the use of epinephrine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group | Length of Action | 0.5% Lidocaine and 0.125% Bupivacaine With Epineph | 7.48 minutes | Standard Deviation 1.76 |
| Study Group | Length of Action | 1% Lidocaine and 0.25% Bupivacaine With Epinephrin | 7.16 minutes | Standard Deviation 1.6 |
| Study Group | Length of Action | 1% Lidocaine With Epinephrine | 6.63 minutes | Standard Deviation 1.85 |
| Study Group | Length of Action | 0.25% Bupivacaine With Epinephrine | 7.02 minutes | Standard Deviation 1.46 |
Comparison: Null Hypothesis is that no difference would be measured between treatment arms.p-value: 0.359ANOVA
Primary
Onset of Action
Time from infusion of local anesthetic to loss of sensation to sharp.
Time frame: Up to 5 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group | Onset of Action | 1% Lidocaine With Epinephrine | 29 second | Standard Deviation 49 |
| Study Group | Onset of Action | 0.25% Bupivacaine With Epinephrine | 19 second | Standard Deviation 41 |
| Study Group | Onset of Action | 0.5% Lidocaine and 0.125% Bupivacaine With Epineph | 26 second | Standard Deviation 46 |
| Study Group | Onset of Action | 1% Lidocaine and 0.25% Bupivacaine With Epinephrin | 12 second | Standard Deviation 30 |
p-value: 0.49ANOVA