IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Effectiveness Study of Different Local Anesthetic Mixtures (CA)
This study has been completed.
Sponsor:
Scott and White Hospital & Clinic
Information provided by (Responsible Party):
James Collins, Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:
NCT01243112
First received: November 17, 2010
Last updated: October 25, 2011
Last verified: October 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Onset and Duration of Effect of Lidocaine, Bupivacaine, and Lidocaine/Bupivacaine Mixture With Epinephrine. |
Resource links provided by NLM:
Further study details as provided by James Collins, Scott and White Hospital & Clinic:
Primary Outcome Measures:
- 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.
| Enrollment: | 25 |
| Study Start Date: | May 2010 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243112
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243112
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
| Responsible Party: | James Collins, MD, Scott and White Hospital & Clinic |
| ClinicalTrials.gov Identifier: | NCT01243112 History of Changes |
| Other Study ID Numbers: |
090520 |
| Study First Received: | November 17, 2010 |
| Results First Received: | September 15, 2011 |
| Last Updated: | October 25, 2011 |
Additional relevant MeSH terms:
|
Lidocaine Bupivacaine 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 |
ClinicalTrials.gov processed this record on June 23, 2017