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Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00793169
First received: November 17, 2008
Last updated: June 28, 2011
Last verified: June 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Murad Alam, Northwestern University
ClinicalTrials.gov 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: June 28, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
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 23, 2013