Clinical trial NCT01463280: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postoperative Thromboembolism
Keywords: Platelets
Inhibition
Lidocaine
Thromboembolism
Prevention
Lidocaine effects on platelets
Lead sponsor: Klein, Jeffrey A., M.D.
Sponsor class: INDIV
First posted: 2011-11-01
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Tumescent lidocaine effects on platelet function following liposuction surgical trauma: a prospective controlled dosage-response phase I clinical trial
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan Capistrano
country: United States
facility: Capistrano Surgicenter
state: California
Study officials:
References: