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Effect of Tumescent Lidocaine on Platelet Function

Primary Purpose

Postoperative Thromboembolism

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tumescent lidocaine infiltration
Sponsored by
Klein, Jeffrey A., M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Thromboembolism focused on measuring Platelets, Inhibition, Lidocaine, Thromboembolism, Prevention, Lidocaine effects on platelets

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Capistrano Surgicenter

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tumescent lidocaine infiltration

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 26, 2011
Last Updated
February 23, 2014
Sponsor
Klein, Jeffrey A., M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01463280
Brief Title
Effect of Tumescent Lidocaine on Platelet Function
Official Title
Tumescent Lidocaine Effects on Platelet Function Following Liposuction Surgical Trauma: a Prospective Controlled Dosage-response Phase I Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klein, Jeffrey A., M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The current research study is intended to examine this hypothesis by determining if tumescent lidocaine increases the results of a test which measures the volume of bleeding which occurs when a tiny standardized incision is made on the forearm. This test is the BA test. The investigators will do BA tests before and after infiltration of lidocaine in the form of tumescent local anesthesia for liposuction and then compare the differences of these BA test results. The purpose of the present research project is to study how platelet function after surgical trauma (liposuction) is affected by tumescent lidocaine. The investigators 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). The Klein Bleeding Area (BA) test is an extension of the classic Ivy Bleeding Time (BT) test. The BT test, an in-vivo test for an abnormal bleeding tendency, involves making a small standardized cut in the skin and measuring the duration of bleeding. The BA test has significantly more sensitivity and specificity than the BT Test. This research project is a dosage-response clinical trial in which the predictor variable is the milligram per kilogram (mg/kg) dosage of tumescent lidocaine and the response variable is the Bleeding Area (BA). A result indicating that tumescent lidocaine does indeed impair post-operative platelet function would justify a subsequent randomized clinical trial of tumescent lidocaine for preventing post-operative thromboembolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Thromboembolism
Keywords
Platelets, Inhibition, Lidocaine, Thromboembolism, Prevention, Lidocaine effects on platelets

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tumescent lidocaine infiltration
Arm Type
Experimental
Arm Description
Assess Platelet function with respect to dosage of tumescent lidocaine There is only one arm.
Intervention Type
Drug
Intervention Name(s)
tumescent lidocaine infiltration
Intervention Description
Tumescent local anesthesia containing dilute lidocaine is infiltrated into subcutaneous tissue prior to liposuction
Primary Outcome Measure Information:
Title
Tumescent lidocaine effects on platelet function following liposuction surgical trauma: a prospective controlled dosage-response phase I clinical trial
Description
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).
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who have requested tumescent liposuction Healthy adults ASA Class I, II, or III Exclusion Criteria: 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
Facility Information:
Facility Name
Capistrano Surgicenter
City
San Juan Capistrano
State/Province
California
ZIP/Postal Code
92675
Country
United States

12. IPD Sharing Statement

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Effect of Tumescent Lidocaine on Platelet Function

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