Clinical Trials Logo
  1. Home
  2. Squamous Cell Carcinoma
  3. NCT00793169
  4. Details
NCT00793169 Clinical Trial

Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

Squamous Cell Carcinoma Clinical Trial

Official title:
Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00793169
Other study ID # MA-stu1404
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2007
Est. completion date July 2008

Study information
Verified date December 2021
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood Draw
Serum levels were measured

Locations
Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 M — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. 6 hours
See also
  Status Clinical Trial Phase
Terminated NCT02213133 - Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas Phase 2
Not yet recruiting NCT04533321 - A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Active, not recruiting NCT01232374 - Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma Phase 2
Completed NCT01208883 - A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer Phase 1
Withdrawn NCT01148082 - School Response to Families Who Have Children With Cancer N/A
Completed NCT01089803 - Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer N/A
Terminated NCT00707655 - Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy Phase 1/Phase 2
Completed NCT01127737 - Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients N/A
Completed NCT00586040 - Photochemical Tissue Bonding Phase 2
Completed NCT00409565 - A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT00176267 - Paclitaxel, Carboplatin And Low Dose Radiation As Induction Therapy In Locally Advanced Head And Neck Cancer Phase 2
Terminated NCT04685798 - Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT N/A
Recruiting NCT04370587 - A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04475952 - Early Diagnosis of Upper Digestive Tract Disease
Recruiting NCT04435938 - A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck Phase 2
Not yet recruiting NCT05852665 - Buccal Cancer Resection Ultrasound Guided N/A
Recruiting NCT05048459 - Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease N/A
Suspended NCT03952585 - De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer Phase 2/Phase 3
Recruiting NCT05574101 - A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer Phase 2