Effect of Tumescent Lidocaine on Platelet Function

Postoperative Thromboembolism Clinical Trial

Official title:

Tumescent Lidocaine Effects on Platelet Function Following Liposuction Surgical Trauma: a Prospective Controlled Dosage-response Phase I Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463280
• Other study ID #: Klein-LidoLipo
• Secondary ID: WIRB Pr#20102004
• Status: Completed
• Phase: Phase 1
• First received: September 26, 2011
• Last updated: February 23, 2014
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Klein, Jeffrey A., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Thromboembolism
• Thromboembolism

Intervention

Drug:
• tumescent lidocaine infiltration
Tumescent local anesthesia containing dilute lidocaine is infiltrated into subcutaneous tissue prior to liposuction

Locations

Country	Name	City	State
United States	Capistrano Surgicenter	San Juan Capistrano	California

Sponsors (1)

Lead Sponsor	Collaborator
Klein, Jeffrey A., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes