NCT00977028

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

6.5 years

First QC Date

September 12, 2009

Last Update Submit

June 14, 2011

Conditions

Anesthesia

Keywords

TumescentLocal AnesthesiaLidocaineDosage MaximumSubcutaneous infiltrationmaximum Safe mg per kg dosage of lidocaineTumescent Local Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Peak or maximum serum lidocaine concentration (Cmax) following a given mg/kg dosage of lidocaine delivered by subcutaneous infiltration of tumescent local anesthesia

    24 hours

Secondary Outcomes (1)

  • 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.

    24 hours

Study Arms (2)

Tumescent Lidocaine with liposuction

EXPERIMENTAL

Determine maximum safe mg/kg dosage of tumescent lidocaine with liposuction

Drug: Tumescent Local Anesthesia (lidocaine, epinephrine)Procedure: Liposuction

Tumescent Lidocaine No Liposuction

EXPERIMENTAL

Determine maximum safe mg/kg dosage of tumescent lidocaine without liposuction

Drug: Tumescent Local Anesthesia (lidocaine, epinephrine)Procedure: Liposuction

Interventions

Tumescent Local Anesthesia (lidocaine, epinephrine)DRUG

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

Also known as: Tumescent, Lidocaine, Xylocaine, Epinephrine, Local, Anesthesia
Tumescent Lidocaine No LiposuctionTumescent Lidocaine with liposuction
LiposuctionPROCEDURE

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

Also known as: tumescent local anesthesia, lidocaine, epinephrine
Tumescent Lidocaine No LiposuctionTumescent Lidocaine with liposuction

Eligibility Criteria

Age18 Years - 72 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of Hepatitis C, HIV
  • ASA class greater or equal to 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capistrano Surgery Center

San Juan Capistrano, California, 92675, United States

Location

MeSH Terms

Interventions

LidocaineEpinephrineAnesthesiaLipectomy

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAnesthesia and AnalgesiaCosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Jeffrey A Klein, MD

    University of Californiia, Riverside

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 12, 2009

First Posted

September 15, 2009

Study Start

January 1, 2005

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

US(1)