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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocane | Patients undergoing Mohs micrographic surgery of the face or neck will have their blood drawn before, during, and after the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Procedure | Serum levels were measured |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. | 6 hours |
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Inclusion Criteria
Exclusion Criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20462662 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Detectable Lidocaine Concentrations at Each Blood Draw | The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Detectable Lidocaine Concentrations at Each Blood Draw | The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. | Analysis was per protocol. | Posted | Number | Participants | 6 hours |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Detectable Lidocaine Concentrations at Each Blood Draw | The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Surgical and medical procedures | A patient reported a headache after the first Mohs micrographic surgery stage. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Murad Alam, MD | Northwestern University | 312-695-6785 | m-alam@northwestern.edu |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D002294 | Carcinoma, Squamous Cell |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 19 |
| 2 |
| 19 |
|
| Shaky | Surgical and medical procedures | A patient reported feeling shaky after the first Mohs micrographic surgery stage. |
|
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| D018295 |
| Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |