Effectiveness Study of Different Local Anesthetic Mixtures (CA)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01243112 |
Recruitment Status :
Completed
First Posted : November 18, 2010
Results First Posted : December 2, 2011
Last Update Posted : December 2, 2011
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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 |
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 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 |

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. |
- 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.
- Onset of Action [ Time Frame: Up to 5 minutes ]Time from infusion of local anesthetic to loss of sensation to sharp.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age: 18-60
Exclusion Criteria:
- Pregnancy
- allergy to local anesthetics
- history of heart disease or diabetes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243112
United States, Texas | |
Scott & White | |
Temple, Texas, United States, 76504 |
Principal Investigator: | James B Collins, MD | Scott and White Healthcare | |
Study Director: | Raman C Mahabir, MD | Scott and White Healthcare |
Responsible Party: | James Collins, MD, Scott and White Hospital & Clinic |
ClinicalTrials.gov Identifier: | NCT01243112 |
Other Study ID Numbers: |
090520 |
First Posted: | November 18, 2010 Key Record Dates |
Results First Posted: | December 2, 2011 |
Last Update Posted: | December 2, 2011 |
Last Verified: | October 2011 |
Lidocaine Epinephrine Racepinephrine Bupivacaine 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 |