Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

NCT ID: NCT00793169

Last Updated: 2021-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Basal Cell Carcinoma Squamous Cell Carcinoma

Keywords

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squamous cell carcinoma of the head or neck

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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lidocane

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

Blood Draw

Intervention Type PROCEDURE

Serum levels were measured

Interventions

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Blood Draw

Serum levels were measured

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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 May 11.

Reference Type RESULT
PMID: 20462662 (View on PubMed)

Other Identifiers

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MA-stu1404

Identifier Type: -

Identifier Source: org_study_id