Effect of Tumescent Lidocaine on Platelet Function
|Postoperative Thromboembolism||Drug: tumescent lidocaine infiltration||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Tumescent Lidocaine Effects on Platelet Function Following Liposuction Surgical Trauma: a Prospective Controlled Dosage-response Phase I Clinical Trial|
- Tumescent lidocaine effects on platelet function following liposuction surgical trauma: a prospective controlled dosage-response phase I clinical trial [ Time Frame: two years ]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).
|Study Start Date:||January 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: tumescent lidocaine infiltration
Assess Platelet function with respect to dosage of tumescent lidocaine There is only one arm.
Drug: tumescent lidocaine infiltration
Tumescent local anesthesia containing dilute lidocaine is infiltrated into subcutaneous tissue prior to 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463280
|United States, California|
|San Juan Capistrano, California, United States, 92675|