Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

NCT00793169 | Completed Results

• 1 other identifier: MA-stu1404
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Basal Cell Carcinoma; Squamous Cell Carcinoma

Keywords

squamous cell carcinoma of the head or neck

Outcome Measures

Primary Outcomes (1)

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

  6 hours

Study Arms (1)

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

Interventions

Blood Draw PROCEDURE

Serum levels were measured

lidocane

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related 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 May 11.

  PMID: 20462662 RESULT

MeSH Terms

Conditions

Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Serum rather than plasma lidocaine levels were measured. For lidocaine levels, plasma and serum levels are similar, and serum levels are more routinely reported by reference laboratories. Hence our selection of serum levels for this study.

Results Point of Contact

• Title: Murad Alam, MD
• Organization: Northwestern University

m-alam@northwestern.edu

312-695-6785

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: September 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 6, 2021
• Results First Posted: November 30, 2010

Record last verified: 2021-12

Locations

US (1)