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Sponsored by: |
University of Pennsylvania |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00594542 |
The purpose of the study will be to demonstrate whether Mohs micrographic surgery can be performed with a lower total dose of local anesthesia (and greater patient safety) when using 0.5% lidocaine with 1:200,000 epinephrine versus 1% lidocaine with 1:100,000 epinephrine.
Condition | Intervention |
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Anesthesia |
Drug: lidocaine |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | A Randomized, Double Blind Comparison of the Total Dose of 1.0% Lidocaine With 1:100,000 Epinephrine Versus 0.5% Lidocaine With 1:200,000 Epinephrine Needed to Achieve Effective Anesthesia During Mohs Micrographic Surgery |
Enrollment: | 149 |
Study Start Date: | June 2007 |
Study Completion Date: | September 2007 |
Arms | Assigned Interventions |
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0.5% lidocaine group: Experimental
Group that receives 0.5% lidocaine with 1:200,000 epinephrine
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Drug: lidocaine
Each group is the appropriate concentration of lidocaine with epinephrine for local anesthesia at the beginning of each Mohs stage and the reconstruction.
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1.0% lidocaine group: Experimental
Group that receives 1.0% lidocaine with 1:100,000 epinephrine
|
Drug: lidocaine
Each group is the appropriate concentration of lidocaine with epinephrine for local anesthesia at the beginning of each Mohs stage and the reconstruction.
|
The purpose of the study will be to demonstrate whether Mohs micrographic surgery can be performed with a lower total dose of local anesthesia (and greater patient safety) when using 0.5% lidocaine with 1:200,000 epinephrine versus 1% lidocaine with 1:100,000 epinephrine. Mohs micrographic surgery is a multi-staged, same-day procedure used to remove skin cancers under local anesthesia. Reconstruction of the surgical wound is also performed under local anesthesia, usually immediately after achieving tumor clearance.
This randomized, double-blind study will systematically compare the total dose of 1.0% lidocaine with 1:100,000 epinephrine versus 0.5% of lidocaine with 1:200,000 epinephrine needed to achieve local anesthesia during Mohs micrographic surgery (MMS). All healthy adult volunteers (18 years or older) undergoing Mohs micrographic surgery at the Hospital of the University of Pennsylvania's Department of Dermatology and Dermatologic Surgery between June 1, 2007 and August 31, 2007 will be eligible to participate in the study. Our primary intervention will be to record the total dose of lidocaine administered throughout all of the MMS stages and reconstructions using either of the two lidocaine concentrations. A secondary intervention will be to record each patient's level of pain control in order to demonstrate that patient comfort is effectively achieved with a lower total dose of local anesthesia. Pregnant or breast-feeding subjects, those with a history of allergic or other adverse reaction to lidocaine or epinephrine, and those who are cognitively impaired will be excluded. In addition, if the surgeon believes that a patient has a tumor which, due to size or anatomic site, may put him at risk for requiring a dose of lidocaine that approaches the threshold of toxicity, this patient will be excluded from the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of Pennsylvania Department of Dermatology ( Christopher J. Miller, M.D. ) |
Study ID Numbers: | UPenn IRB-806101 |
Study First Received: | January 2, 2008 |
Last Updated: | January 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00594542 |
Health Authority: | United States: Institutional Review Board |
lidocaine local anesthesia Mohs micrographic surgery |
Lidocaine Epinephrine |
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