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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.
Procedures
During your participation the following procedures will be completed:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine w/ Epi | Experimental | 0.2ml 1% Lidocaine with Epinephrine (1:100,000) |
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| Bupivacaine with epi | Experimental | 0.2 ml 0.25% Bupivacaine with epinephrine (1:200,000) |
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| Low dose Lido and Bupi w/ Epi | Experimental | 0.2ml 0.5% Lidocaine + 0.125% Bupivacaine with Epinephrine (1:150,000) |
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| High Dose Lido and Bupi with epi | Experimental | 0.2ml 1% Lidocaine + 0.25% Bupivacaine with Epinephrine (1:150,000) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% Lidocaine with Epinephrine (1:100,000) | Drug | 0.2ml Intradermal injection once. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Action | The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments. | Up to 12 hours |
| Onset of Action | Time from infusion of local anesthetic to loss of sensation to sharp. | Up to 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James B Collins, MD | Scott and White Healthcare | Principal Investigator |
| Raman C Mahabir, MD | Scott and White Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scott & White | Temple | Texas | 76504 | United States |
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Subjects were recruited by hospital mailing list with 25 subjects enrolled over May 2010 until September 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 0.25% Bupivacaine with Epinephrine (1:200,000) |
| Drug |
0.2ml Intradermal injection once. |
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| 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000) | Drug | 0.2ml Intradermal injection once. |
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| 1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000) | Drug | 0.2ml Intradermal injection once. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Action | The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments. | 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. | Posted | Mean | Standard Deviation | minutes | Up to 12 hours |
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| Primary | Onset of Action | Time from infusion of local anesthetic to loss of sensation to sharp. | Posted | Mean | Standard Deviation | second | Up to 5 minutes |
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7/24/10 to 8/28/10
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Collins, MD | Scott & White Healthcare | 254-724-7508 | 0612 | jbcollins@swmail.sw.org |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| 1% Lidocaine and 0.25% Bupivacaine With Epinephrin |
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| Title | Denominators | Categories |
|---|
| 1% Lidocaine With Epinephrine |
| |||||
| 0.25% Bupivacaine With Epinephrine |
| |||||
| 0.5% Lidocaine and 0.125% Bupivacaine With Epineph |
| |||||
| 1% Lidocaine and 0.25% Bupivacaine With Epinephrin |
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