Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

December 2, 2021 updated by: Murad Alam, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 18, 2008

First Posted (Estimate)

November 19, 2008

Study Record Updates

Last Update Posted (Actual)

December 6, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-stu1404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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