Effect of Tumescent Lidocaine on Platelet Function
Primary Purpose
Postoperative Thromboembolism
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tumescent lidocaine infiltration
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Thromboembolism focused on measuring Platelets, Inhibition, Lidocaine, Thromboembolism, Prevention, Lidocaine effects on platelets
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
Sites / Locations
- Capistrano Surgicenter
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tumescent lidocaine infiltration
Arm Description
Assess Platelet function with respect to dosage of tumescent lidocaine There is only one arm.
Outcomes
Primary Outcome Measures
Tumescent lidocaine effects on platelet function following liposuction surgical trauma: a prospective controlled dosage-response phase I clinical trial
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01463280
First Posted
September 26, 2011
Last Updated
February 23, 2014
Sponsor
Klein, Jeffrey A., M.D.
1. Study Identification
Unique Protocol Identification Number
NCT01463280
Brief Title
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
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klein, Jeffrey A., M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Thromboembolism
Keywords
Platelets, Inhibition, Lidocaine, Thromboembolism, Prevention, Lidocaine effects on platelets
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tumescent lidocaine infiltration
Arm Type
Experimental
Arm Description
Assess Platelet function with respect to dosage of tumescent lidocaine There is only one arm.
Intervention Type
Drug
Intervention Name(s)
tumescent lidocaine infiltration
Intervention Description
Tumescent local anesthesia containing dilute lidocaine is infiltrated into subcutaneous tissue prior to liposuction
Primary Outcome Measure Information:
Title
Tumescent lidocaine effects on platelet function following liposuction surgical trauma: a prospective controlled dosage-response phase I clinical trial
Description
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).
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Capistrano Surgicenter
City
San Juan Capistrano
State/Province
California
ZIP/Postal Code
92675
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Tumescent Lidocaine on Platelet Function
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