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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014