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Tumescent Lidocaine Maximum Safe mg/kg Dosage

NCT00977028 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2011-06-16

No results posted yet for this study

Summary

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.

Conditions

  • Anesthesia

Interventions

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

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

Sponsors & Collaborators

  • Klein, Jeffrey A., M.D.

    lead INDIV

Principal Investigators

  • Jeffrey A Klein, MD · University of Californiia, Riverside

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2011-07-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00977028 on ClinicalTrials.gov