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NCT00793169 Clinical Trial

Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

Squamous Cell Carcinoma Clinical Trial

Official title:
Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00793169
Other study ID # MA-stu1404
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2007
Est. completion date July 2008

Study information
Verified date December 2021
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood Draw
Serum levels were measured

Locations
Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Alam M, Ricci D, Havey J, Rademaker A, Witherspoon J, West DP. Safety of peak serum lidocaine concentration after Mohs micrographic surgery: a prospective cohort study. J Am Acad Dermatol. 2010 Jul;63(1):87-92. doi: 10.1016/j.jaad.2009.08.046. Epub 2010 M — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. 6 hours
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