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Tumescent Lidocaine Maximum Safe mg/kg Dosage (TLA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Klein, Jeffrey A., M.D..
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00977028
First Posted: September 15, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Klein, Jeffrey A., M.D.
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tumescent Lidocaine Bioavailability and Absorption Kinetics:Maximum Safe mg/kg Lidocaine Dosage

Resource links provided by NLM:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 12, 2009
First Posted: September 15, 2009
Last Update Posted: October 12, 2017
Last Verified: June 2011

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:
Anesthetics
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents