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Completed

NCT Number: NCT00793169

Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma Squamous Cell Carcinoma of Head and Neck

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw

Procedure

Serum levels were measured

Primary outcomes

  1. The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw.

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 19, 2008
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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