Effect of Tumescent Lidocaine on Platelet Function

NCT ID: NCT01463280

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-12-31

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.

Conditions

Postoperative Thromboembolism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

tumescent lidocaine infiltration

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

Group Type: EXPERIMENTAL

tumescent lidocaine infiltration

Intervention Type: DRUG

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

Interventions

tumescent lidocaine infiltration

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Klein, Jeffrey A., M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Capistrano Surgicenter

San Juan Capistrano, California, United States

Countries

United States

Other Identifiers

WIRB Pr#20102004

Identifier Type: OTHER

Identifier Source: secondary_id

Klein-LidoLipo

Identifier Type: -

Identifier Source: org_study_id