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Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

This study has been completed.
Information provided by (Responsible Party):
Murad Alam, Northwestern University Identifier:
First received: November 17, 2008
Last updated: February 19, 2015
Last verified: February 2015
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 Intervention
Basal Cell Carcinoma
Squamous Cell Carcinoma
Procedure: Blood Draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

Resource links provided by NLM:

Further study details as provided by Northwestern University:

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

Enrollment: 19
Study Start Date: September 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00793169

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

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University Identifier: NCT00793169     History of Changes
Other Study ID Numbers: MA-stu1404
Study First Received: November 17, 2008
Results First Received: September 30, 2010
Last Updated: February 19, 2015

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms, Basal Cell
Anesthetics, Local
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 processed this record on April 28, 2017