N/A
N=19
Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Basal Cell Carcinoma · Squamous Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00793169 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcome: Primary: The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. — 0; 1; 0; 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Blood Draw (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jul 2008
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 | — |
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.
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
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.