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Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

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ClinicalTrials.gov Identifier: NCT00793169
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : November 30, 2010
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Brief Summary:
The primary objective of this study is to (1) determine whether local injection of lidocaine used during Mohs surgery will elevate serum lidocaine concentrations to a level that could cause systemic symptoms and (2) determine whether sustained high levels of serum lidocaine occur after intralesional anesthesia on the face and neck. This study is a cross-sectional study of 10 subjects with basal cell carcinoma or squamous cell carcinoma of the face or neck requiring Mohs micrographic surgery. The study will consist of a brief questionnaire and blood draws during their Moh's surgical procedure.

Condition or disease Intervention/treatment
Basal Cell Carcinoma Squamous Cell Carcinoma Procedure: Blood Draw

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Study Start Date : September 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine
U.S. FDA Resources

Group/Cohort Intervention/treatment
lidocane
Patients undergoing Mohs micrographic surgery of the face or neck will have their blood drawn before, during, and after the procedure.
Procedure: Blood Draw
Serum levels were measured



Primary Outcome Measures :
  1. The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. [ Time Frame: 6 hours ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study is a cross-sectional study of 20 subjects with basal cell carcinoma or squamous cell carcinoma of the face or neck requiring Mohs micrographic surgery.
Criteria

Inclusion Criteria

  • Age: 18-75
  • Basal cell carcinoma or squamous cell carcinoma of the head or neck
  • Subjects are in good health
  • Subjects that have the willingness and the ability to understand and provide informed consent for the use of their blood and communicate with the investigator

Exclusion Criteria

  • Lidocaine sensitivity
  • Bleeding disorder
  • Pregnancy
  • Medical conditions which would impair hepatic blood flow: congestive heart failure, liver dysfunction, peripheral vascular disease.
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793169


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University

Publications of Results:
Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT00793169     History of Changes
Other Study ID Numbers: MA-stu1404
First Posted: November 19, 2008    Key Record Dates
Results First Posted: November 30, 2010
Last Update Posted: March 6, 2015
Last Verified: February 2015

Keywords provided by Murad Alam, Northwestern University:
squamous cell carcinoma of the head or neck

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action