Effectiveness Study of Different Local Anesthetic Mixtures - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, 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:

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Lidocaine hydrochloride Lidocaine Racepinephrine hydrochloride Racepinephrine Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by Scott and White Hospital & Clinic:

Primary Outcome Measures:

Length of Action [ Time Frame: Up to 12 hours ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Genders Eligible for Study:	Both
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

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

No publications provided


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
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Bupivacaine Epinephrine Epinephryl borate Lidocaine Racepinephrine Adrenergic Agents Adrenergic Agonists Adrenergic alpha-Agonists Adrenergic beta-Agonists Anesthetics Anesthetics, Local Anti-Arrhythmia Agents Anti-Asthmatic Agents Autonomic Agents Bronchodilator Agents	Cardiovascular Agents Central Nervous System Agents Central Nervous System Depressants Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Mydriatics Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Sensory System Agents Sodium Channel Blockers Sympathomimetics Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

Effectiveness Study of Different Local Anesthetic Mixtures (CA)