PainPhase 4CANCT01243112

Effectiveness Study of Different Local Anesthetic Mixtures

A Phase 4 study testing 1% Lidocaine with Epinephrine (1:100,000), 0.25% Bupivacaine with Epinephrine (1:200,000) and 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000) in people with Pain, run by Scott and White Hospital & Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: 1% Lidocaine with Epinephrine (1:100,000), 0.25% Bupivacaine with Epinephrine (1:200,000) and 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: May 2010to Sep 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age: 18-60

Who cannot join

Pregnancy
allergy to local anesthetics
history of heart disease or diabetes

Trial locations and contacts

1 site in 1 country.

United States1 site

Scott & White
Temple, Texas, 76504

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Pain
Being tested: 1% Lidocaine with Epinephrine (1:100,000), 0.25% Bupivacaine with Epinephrine (1:200,000), 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000), 1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT01243112
Study group	Role	What they receive
Lidocaine w/ Epi	Experimental	0.2ml 1% Lidocaine with Epinephrine (1:100,000) Receives: Drug: 1% Lidocaine with Epinephrine (1:100,000)
Bupivacaine with epi	Experimental	0.2 ml 0.25% Bupivacaine with epinephrine (1:200,000) Receives: Drug: 0.25% Bupivacaine with Epinephrine (1:200,000)
Low dose Lido and Bupi w/ Epi	Experimental	0.2ml 0.5% Lidocaine + 0.125% Bupivacaine with Epinephrine (1:150,000) Receives: Drug: 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000)
High Dose Lido and Bupi with epi	Experimental	0.2ml 1% Lidocaine + 0.25% Bupivacaine with Epinephrine (1:150,000) Receives: Drug: 1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)

What is being measured

The primary outcome is the main question the study is designed to answer.

Length of Action
The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.
Measured: Up to 12 hours
Onset of Action
Time from infusion of local anesthetic to loss of sensation to sharp.
Measured: Up to 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Sep 2010

First posted18 Nov 2010 (estimated)
Study startMay 2010
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01243112
Sponsor's protocol ID: 090520
Acronym: CA
Status last verified: Oct 2011
First submitted: 17 Nov 2010
Last updated: 2 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Onset and Duration of Effect of Lidocaine, Bupivacaine, and Lidocaine/Bupivacaine Mixture With Epinephrine.
ClinicalTrials.gov ID: NCT01243112
Acronym / sponsor ID: CA / 090520
Conditions: Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Scott and White Hospital & ClinicUniversity, hospital or other
Study start: May 2010
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 18 Nov 2010 (estimated)
Results: Posted 2 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Lidocaine w/ Epi	Experimental	Drug: 1% Lidocaine with Epinephrine (1:100,000)0.2ml 1% Lidocaine with Epinephrine (1:100,000)
Bupivacaine with epi	Experimental	Drug: 0.25% Bupivacaine with Epinephrine (1:200,000)0.2 ml 0.25% Bupivacaine with epinephrine (1:200,000)
Low dose Lido and Bupi w/ Epi	Experimental	Drug: 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000)0.2ml 0.5% Lidocaine + 0.125% Bupivacaine with Epinephrine (1:150,000)
High Dose Lido and Bupi with epi	Experimental	Drug: 1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)0.2ml 1% Lidocaine + 0.25% Bupivacaine with Epinephrine (1:150,000)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Age: 18-60

Key exclusion criteria (3 listed)

Pregnancy
allergy to local anesthetics
history of heart disease or diabetes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1% Lidocaine with Epinephrine (1:100,000)0.2ml Intradermal injection once.	Drug	Lidocaine w/ Epi
0.25% Bupivacaine with Epinephrine (1:200,000)0.2ml Intradermal injection once.	Drug	Bupivacaine with epi
0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000)0.2ml Intradermal injection once.	Drug	Low dose Lido and Bupi w/ Epi
1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)0.2ml Intradermal injection once.	Drug	High Dose Lido and Bupi with epi

Primary outcome

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.

Results and safety

Results posted to the registry on 2 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Group	25	25

Primary outcome: Length of Action

Time frame: Up to 12 hours. Mean (Standard Deviation). Unit: minutes

Measure	Study Group n = 25
1% Lidocaine With Epinephrine	6.63 (1.85)
0.25% Bupivacaine With Epinephrine	7.02 (1.46)
0.5% Lidocaine and 0.125% Bupivacaine With Epineph	7.48 (1.76)
1% Lidocaine and 0.25% Bupivacaine With Epinephrin	7.16 (1.60)

Study Group: p = 0.359, ANOVA

Population analysed: A calculation was made to power the study appropriately to determine a difference of 5 minutes based on previous studies which did not include the use of epinephrine.

Primary outcome: Onset of Action

Time frame: Up to 5 minutes. Mean (Standard Deviation). Unit: second

Measure	Study Group n = 25
1% Lidocaine With Epinephrine	29 (49)
0.25% Bupivacaine With Epinephrine	19 (41)
0.5% Lidocaine and 0.125% Bupivacaine With Epineph	26 (46)
1% Lidocaine and 0.25% Bupivacaine With Epinephrin	12 (30)

Study Group: p = 0.490, ANOVA

Adverse events

Time frame: 7/24/10 to 8/28/10. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Group	0 of 25 (0%)	0 of 25 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James B Collins, MD principal investigator

Scott and White Healthcare

Raman C Mahabir, MD study director

Scott and White Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Action (time frame: Up to 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01243112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2011.