Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
This study has been completed.
Information provided by (Responsible Party):
Murad Alam, Northwestern University
First received: November 17, 2008
Last updated: February 19, 2015
Last verified: February 2015
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.
Basal Cell Carcinoma
Squamous Cell Carcinoma
Procedure: Blood Draw
||Observational Model: Cohort
Time Perspective: Prospective
||Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Primary Outcome Measures:
- The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2008 (Final data collection date for primary outcome measure)
Patients undergoing Mohs micrographic surgery of the face or neck will have their blood drawn before, during, and after the procedure.
Procedure: Blood Draw
Serum levels were measured
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- Lidocaine sensitivity
- Bleeding disorder
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793169
|Chicago, Illinois, United States, 60611 |
||Murad Alam, MD
||Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 17, 2008
|Results First Received:
||September 30, 2010
||February 19, 2015
||United States: Institutional Review Board
Keywords provided by Northwestern University:
squamous cell carcinoma of the head or neck
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 16, 2015
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell