Effect of Tumescent Lidocaine on Platelet Function
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Thromboembolism |
Drug: tumescent lidocaine infiltration |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 ] [ Designated as safety issue: Yes ]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).
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Klein, Jeffrey A., M.D. |
| ClinicalTrials.gov Identifier: | NCT01463280 History of Changes |
| Other Study ID Numbers: | Klein-LidoLipo, WIRB Pr#20102004 |
| Study First Received: | September 26, 2011 |
| Last Updated: | October 31, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Klein, Jeffrey A., M.D.:
|
Platelets Inhibition Lidocaine |
Thromboembolism Prevention Lidocaine effects on platelets |
Additional relevant MeSH terms:
|
Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013