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Tumescent Lidocaine Maximum Safe mg/kg Dosage (TLA)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Klein, Jeffrey A., M.D.
ClinicalTrials.gov Identifier:
NCT00977028
First received: September 12, 2009
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  Purpose

This pharmacokinetic clinical trial is a dose ranging study of lidocaine in tumescent local anesthesia. The goal is to understand the absorption pharmacokinetic of tumescent lidocaine and to determine an objective (statistical) estimate of the maximum safe mg/kg dosage of lidocaine in tumescent local anesthesia without liposuction.


Condition Intervention Phase
Anesthesia
 Drug: Tumescent Local Anesthesia (lidocaine, epinephrine)
Procedure: Liposuction
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tumescent Lidocaine Bioavailability and Absorption Kinetics:Maximum Safe mg/kg Lidocaine Dosage

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Klein, Jeffrey A., M.D.:

Primary Outcome Measures:
  • Peak or maximum serum lidocaine concentration (Cmax) following a given mg/kg dosage of lidocaine delivered by subcutaneous infiltration of tumescent local anesthesia [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cmax following 45mg/kg tumescent lidocaine has a Normal distribution. We define the probability that Cmax exceeds 6 microgram/ml, the toxic threshold for lidocaine as a function of lidocaine dosage. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: January 2005
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tumescent Lidocaine with liposuction
Determine maximum safe mg/kg dosage of tumescent lidocaine with liposuction
 Drug: Tumescent Local Anesthesia (lidocaine, epinephrine)
Tumescent solution of lidocaine (up to 1 gm per liter) and epinephrine (up to 1 mg per liter)with subcutaneous infiltration of up to 45 mg per kilogram
Other Names:
  • Tumescent
  • Lidocaine
  • Xylocaine
  • Epinephrine
  • Local
  • Anesthesia
Procedure: Liposuction
Subcutaneous infiltration of tumescent local anesthesia (large volumes of dilute lidocaine and epinephrine) on at least two different occasions, followed by sequential serum samples every two hours for HPLC determination of serum lidocaine concentration and peak serum lidocaine concentration, initially without subsequent liposuction and finally on the last occasion with liposuction
Other Names:
  • tumescent local anesthesia
  • lidocaine
  • epinephrine
Experimental: Tumescent Lidocaine No Liposuction
Determine maximum safe mg/kg dosage of tumescent lidocaine without liposuction
 Drug: Tumescent Local Anesthesia (lidocaine, epinephrine)
Tumescent solution of lidocaine (up to 1 gm per liter) and epinephrine (up to 1 mg per liter)with subcutaneous infiltration of up to 45 mg per kilogram
Other Names:
  • Tumescent
  • Lidocaine
  • Xylocaine
  • Epinephrine
  • Local
  • Anesthesia
Procedure: Liposuction
Subcutaneous infiltration of tumescent local anesthesia (large volumes of dilute lidocaine and epinephrine) on at least two different occasions, followed by sequential serum samples every two hours for HPLC determination of serum lidocaine concentration and peak serum lidocaine concentration, initially without subsequent liposuction and finally on the last occasion with liposuction
Other Names:
  • tumescent local anesthesia
  • lidocaine
  • epinephrine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female (ASA class 1 or 2)
  • Desires liposuction
  • Easily accessible veins

Exclusion Criteria:

  • History of Hepatitis C, HIV
  • ASA class greater or equal to 3
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977028

Locations
United States, California
Capistrano Surgery Center
San Juan Capistrano, California, United States, 92675
Sponsors and Collaborators
Klein, Jeffrey A., M.D.
Investigators
Principal Investigator: Jeffrey A Klein, MD University of Californiia, Riverside
  More Information

No publications provided

Responsible Party: Jeffrey A. Klein, MD, Jeffrey A. Klein, MD, Inc.
ClinicalTrials.gov Identifier: NCT00977028     History of Changes
Other Study ID Numbers: 1 TLA Peak
Study First Received: September 12, 2009
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Klein, Jeffrey A., M.D.:
Tumescent
Local Anesthesia
Lidocaine
Dosage Maximum
 Subcutaneous infiltration
maximum Safe mg per kg dosage of lidocaine
Tumescent Local Anesthesia

Additional relevant MeSH terms:
Epinephrine
Epinephryl borate
Lidocaine
Anesthetics
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Depressants
Central Nervous System Agents
Anesthetics, Local
Sensory System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on June 18, 2013