Effect of Tumescent Lidocaine on Platelet Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klein, Jeffrey A., M.D.
ClinicalTrials.gov Identifier:
NCT01463280
First received: September 26, 2011
Last updated: February 23, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Klein, Jeffrey A., M.D.:

Primary Outcome Measures:
  • 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).


Enrollment: 129
Study Start Date: January 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463280

Locations
United States, California
Capistrano Surgicenter
San Juan Capistrano, California, United States, 92675
Sponsors and Collaborators
Klein, Jeffrey A., M.D.
  More 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: February 23, 2014
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
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 21, 2014