Comparison of the Total Dose and Efficacy of Two Lidocaine Concentrations Needed for Cutaneous Surgery Local Anesthesia

ID: NCT00594542
Status: Completed
Phase: N/A
Start Date: June 01, 2007
First Submitted: January 02, 2008
Last Updated: January 03, 2008
Results: N/A
Sponsors & Collaborators: University of Pennsylvania
Location: N/A
Conditions: Anesthesia
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Study Description

Brief Summary

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.

Detailed Description

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.
Condition or disease Intervention/treatment Phase

Anesthesia

Drug: lidocaine
Other Names
N/A

Tracking Information

First Submitted DateJanuary 02, 2008
Last Update Posted DateJanuary 03, 2008
Start DateJune 01, 2007
Actual Completion DateSeptember 01, 2007
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • The primary outcome is a measurement of the total dose of lidocaine (measured in mg) administered to the patient over the course of Mohs micrographic surgery. [Time Frame: One day]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • The secondary outcome is subject pain, as assessed by a visual analog pain scale and by the volume of extra rescue lidocaine needed during surgery. [Time Frame: One day]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleComparison of the Total Dose and Efficacy of Two Lidocaine Concentrations Needed for Cutaneous Surgery Local Anesthesia
Official TitleA 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
Brief Summary

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.

Detailed Description

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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
149
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Not Available
Conditions
Anesthesia
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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.

Other Names
Study Groups/Cohorts
0.5% lidocaine group
Group that receives 0.5% lidocaine with 1:200,000 epinephrine

1.0% lidocaine group
Group that receives 1.0% lidocaine with 1:100,000 epinephrine

Study Arms
Experimental 0.5% lidocaine group
Group that receives 0.5% lidocaine with 1:200,000 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.

Experimental 1.0% lidocaine group
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.

Arm Intervention/Treatment
Experimental 0.5% lidocaine group
Group that receives 0.5% lidocaine with 1:200,000 epinephrine
Drug : lidocaine
Experimental 1.0% lidocaine group
Group that receives 1.0% lidocaine with 1:100,000 epinephrine
Drug : lidocaine

Recruitment Information

Recruitment Status:Completed
Enrollment149
Completion DateSeptember 01, 2007
Eligibility Criteria: Inclusion Criteria:
- 18 years or older
- Mohs micrographic surgery patient

Exclusion Criteria:
- Pregnant or breast-feeding subjectsH
- History of allergic or other adverse reaction to lidocaine or epinephrine
- Cognitively impairment
- Surgeon judges patient a risk for lidocaine toxicity due to tumor size
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT00594542
Other Study ID Numbers
UPenn IRB-806101
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyChristopher J. Miller, M.D.,
Study Sponsor
University of Pennsylvania
Collaborators
Not Available
Investigators
Principal Investigator
Christopher J Miller, MD
University of Pennsylvania Department of Dermatology