Effectiveness Study of Different Local Anesthetic Mixtures

NCT01243112 | Completed Phase 4 Results

• 1 other identifier: 090520
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• Length of Action

  The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.

  Up to 12 hours

• Onset of Action

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

  Up to 5 minutes

Study Arms (4)

Lidocaine w/ Epi

EXPERIMENTAL

0.2ml 1% Lidocaine with Epinephrine (1:100,000)

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

Bupivacaine with epi

EXPERIMENTAL

0.2 ml 0.25% Bupivacaine with epinephrine (1:200,000)

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)

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)

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

Interventions

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

0.2ml Intradermal injection once.

Lidocaine w/ Epi

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

0.2ml Intradermal injection once.

Bupivacaine with epi

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

0.2ml Intradermal injection once.

Low dose Lido and Bupi w/ Epi

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

0.2ml Intradermal injection once.

High Dose Lido and Bupi with epi

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-60

You may not qualify if:

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

Sponsors & Collaborators

• Scott and White Hospital & Clinic: lead

Study Sites (1)

Scott & White

Temple, Texas, 76504, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Epinephrine; Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: James Collins, MD
• Organization: Scott & White Healthcare

jbcollins@swmail.sw.org

254-724-7508

Study Officials

• James B Collins, MD

  Scott and White Healthcare

  PRINCIPAL INVESTIGATOR

• Raman C Mahabir, MD

  Scott and White Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 18, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 2, 2011
• Results First Posted: December 2, 2011

Record last verified: 2011-10

Locations

US (1)