CA: Effectiveness Study of Different Local Anesthetic Mixtures

• Sponsor: Scott and White Hospital & Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01243112
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 4
• Duration (Months): 4
• Patients Per Site Per Month: 6.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Onset and Duration of Effect of Lidocaine, Bupivacaine, and Lidocaine/Bupivacaine Mixture With Epinephrine.
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Length of Action [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 [Up to 5 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age: 18-60

Exclusion Criteria:

• Pregnancy

• allergy to local anesthetics

• history of heart disease or diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: James Collins, MD, Scott and White Hospital & Clinic
• ClinicalTrials.gov Identifier: NCT01243112
• Other Study ID Numbers: 090520
• First Posted: Nov 18, 2010
• Last Update Posted: Dec 2, 2011
• Last Verified: Oct 1, 2011

• Additional relevant MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate

Study Results

Participant Flow

Recruitment Details	Subjects were recruited by hospital mailing list with 25 subjects enrolled over May 2010 until September 2010.

Arm/Group Title	Study Group
Arm/Group Description	0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
Period Title: Overall Study
STARTED	25
COMPLETED	25
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Study Group
Arm/Group Description	0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
Overall Participants	25
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	25 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36 (9.7)
Sex: Female, Male (Count of Participants)
Female	18 72%
Male	7 28%
Region of Enrollment (participants) [Number]
United States	25 100%

Outcome Measures

1. Primary Outcome

Title	Length of Action
Description	The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.
Time Frame	Up to 12 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Study Group
Arm/Group Description	0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
Measure Participants	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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Study Group
	Comments	Null Hypothesis is that no difference would be measured between treatment arms.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.359
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Onset of Action
Description	Time from infusion of local anesthetic to loss of sensation to sharp.
Time Frame	Up to 5 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Group
Arm/Group Description	0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
Measure Participants	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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Study Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.490
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	7/24/10 to 8/28/10
Arm/Group Title	Study Group
Arm/Group Description	0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
All Cause Mortality
	Study Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Study Group
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	Study Group
	Affected / at Risk (%)	# Events
Total	0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.