NCT01463280

Brief Summary

The purpose of this study is to evaluate the effect of lidocaine, delivered into subcutaneous tissue for tumescent local anesthesia, on platelet activation following the tumescent liposuction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

2.9 years

First QC Date

September 26, 2011

Last Update Submit

February 23, 2014

Conditions

Postoperative Thromboembolism

Keywords

PlateletsInhibitionLidocaineThromboembolismPreventionLidocaine effects on platelets

Outcome Measures

Primary Outcomes (1)

  • Tumescent lidocaine effects on platelet function following liposuction surgical trauma: a prospective controlled dosage-response phase I clinical trial

    The purpose of the present research project is to study how platelet function after surgical trauma (liposuction) is affected by tumescent lidocaine. We hypothesize that lidocaine, delivered in the form of tumescent local anesthesia, inhibits surgical trauma-induced platelet activation as measured by the in-vivo Klein Bleeding Area test (www.onlinePFT).

    two years

Study Arms (1)

tumescent lidocaine infiltration

EXPERIMENTAL

Assess Platelet function with respect to dosage of tumescent lidocaine There is only one arm.

Drug: tumescent lidocaine infiltration

Interventions

tumescent lidocaine infiltrationDRUG

Tumescent local anesthesia containing dilute lidocaine is infiltrated into subcutaneous tissue prior to liposuction

tumescent lidocaine infiltration

Eligibility Criteria

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

You may qualify if:

  • Patients who have requested tumescent liposuction
  • Healthy adults
  • ASA Class I, II, or III

You may not qualify if:

  • Known allergy to lidocaine
  • younger than 18 years
  • Positive serology for Hepatitis C, HIV
  • Chronic fatigue Syndrome
  • known bleeding disorder
  • significant psychiatric problems
  • History of seizures
  • Clinically significant cardiac arrhythmia
  • Conditions predisposing to surgical site infections
  • Active bacterial infection
  • taking drugs know to affect hemostasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capistrano Surgicenter

San Juan Capistrano, California, 92675, United States

Location

MeSH Terms

Conditions

Inhibition, PsychologicalThromboembolism

Condition Hierarchy (Ancestors)

BehaviorEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2011

First Posted

November 1, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

US(1)