N/A Completed N=19

Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

basal cell carcinoma · Squamous Cell Carcinoma

Source: ClinicalTrials.gov NCT00793169 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2010

Primary outcomePrimary: The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. — 0; 1; 0; 2 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw.	0; 1; 0; 2; 1; 5	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00793169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.