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临床试验/NCT01463280
NCT01463280已完成1 期

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

Klein, Jeffrey A., M.D.1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
129
试验地点
1
主要终点
Tumescent lidocaine effects on platelet function following liposuction surgical trauma: a prospective controlled dosage-response phase I clinical trial

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients who have requested tumescent liposuction
  • •Healthy adults
  • •ASA Class I, II, or III

排除标准

  • •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

研究组 & 干预措施

tumescent lidocaine infiltration

Experimental

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

干预措施: tumescent lidocaine infiltration (Drug)

结局指标

主要结局

Tumescent lidocaine effects on platelet function following liposuction surgical trauma: a prospective controlled dosage-response phase I clinical trial

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Klein, Jeffrey A., M.D.
申办方类型
Indiv
责任方
Sponsor

研究点 (1)

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