Basal Cell Carcinoma, Squamous Cell Carcinoma
Conditions
Keywords
squamous cell carcinoma of the head or neck
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.
Interventions
PROCEDUREBlood Draw
Serum levels were measured
Sponsors
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. | 6 hours |
Countries
United States
Participant flow
Recruitment details
Patients aged 18 years and older presenting to the university for Mohs micrographic surgery for removal of basal cell or cutaneous squamous cell carcinoma of the head and neck were eligible for enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Detectable Lidocaine Concentrations at Each Blood Draw The number of subjects with detectable serum lidocaine concentrations (\<0.1 ug/mL) at each blood draw. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Detectable Lidocaine Concentrations at Each Blood Draw |
|---|---|
| Age, Continuous | 60 years |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw.
Time frame: 6 hours
Population: Analysis was per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Detectable Lidocaine Concentrations at Each Blood Draw | The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. | Blood Draw 1 | 0 Participants |
| Detectable Lidocaine Concentrations at Each Blood Draw | The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. | Blood Draw 2 | 1 Participants |
| Detectable Lidocaine Concentrations at Each Blood Draw | The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. | Blood Draw 3 | 0 Participants |
| Detectable Lidocaine Concentrations at Each Blood Draw | The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. | Blood Draw 4 | 2 Participants |
| Detectable Lidocaine Concentrations at Each Blood Draw | The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. | Blood Draw 5 | 1 Participants |
| Detectable Lidocaine Concentrations at Each Blood Draw | The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. | Blood Draw 6 | 5 Participants |