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