Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery - Full Text View

Sponsored by:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00793169

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
Basal Cell Carcinoma Squamous Cell Carcinoma

MedlinePlus related topics: Anesthesia

Drug Information available for: Lidocaine

U.S. FDA Resources

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

Further study details as provided by Northwestern University:

Primary Outcome Measures:

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. [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A secondary outcome measure is to determine whether sustained high levels of serum lidocaine levels occur after intralesional anesthesia on the face and neck. [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Enrollment:	20
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
lidocane Patients undergoing Mohs micrographic surgery of the face or neck will have their blood drawn before, during, and after the procedure.

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

More Information

Responsible Party:	Northwestern University ( Murad Alam )
Study ID Numbers:	MA-stu1404
Study First Received:	November 17, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00793169
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

squamous cell carcinoma of the head or neck

Study placed in the following topic categories:

Epidermoid carcinoma
Squamous cell carcinoma
Lidocaine
Carcinoma, squamous cell
Carcinoma, Basal Cell

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on January 15, 2009