Ignite Creation Date:
2024-05-05 @ 11:03 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01243112
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2010-11-17
Brief Title:
Effectiveness Study of Different Local Anesthetic Mixtures
Sponsor:
Scott and White Hospital Clinic
Organization:
Scott and White Hospital Clinic
Study Overview
Official Title:
Onset and Duration of Effect of Lidocaine Bupivacaine and LidocaineBupivacaine Mixture With Epinephrine
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CA
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None