Skip to main content
OpenTrials
Completed

NCT Number: NCT01243112

Effectiveness Study of Different Local Anesthetic Mixtures

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Scott & White

Temple, Texas, 76504, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-60

Exclusion criteria

  • Pregnancy
  • allergy to local anesthetics
  • history of heart disease or diabetes

Treatment and study plan

1% Lidocaine with Epinephrine (1:100,000)

Drug

0.2ml Intradermal injection once.

0.25% Bupivacaine with Epinephrine (1:200,000)

Drug

0.2ml Intradermal injection once.

0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000)

Drug

0.2ml Intradermal injection once.

1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)

Drug

0.2ml Intradermal injection once.

Primary outcomes

  1. 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.

  2. Onset of Action

    Time frame: Up to 5 minutes

    Time from infusion of local anesthetic to loss of sensation to sharp.

Sponsors and collaborators

Lead sponsor

Scott and White Hospital & Clinic

Other

Registry information

Official study title

Onset and Duration of Effect of Lidocaine, Bupivacaine, and Lidocaine/Bupivacaine Mixture With Epinephrine.

Acronym: CA

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 18, 2010
Registry last updated
Dec 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.