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

Organization: University of Pennsylvania

Sponsors & Collaborators: University of Pennsylvania

Location: N/A

Conditions: Anesthesia

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Study Details
No Results Posted

Study Description

Brief Summary

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 Date	January 02, 2008
Last Update Posted Date	January 03, 2008
Start Date	June 01, 2007
Actual Completion Date	September 01, 2007
Primary Completion Date	N/A
Results First Submitted Date	N/A
Received Results Disposit Date	N/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 Title	Comparison of the Total Dose and Efficacy of Two Lidocaine Concentrations Needed for Cutaneous Surgery Local Anesthesia
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
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 Type	Interventional
Study Phase	N/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 Method	N/A
Study Population	N/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 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.

Recruitment Information

Recruitment Status:	Completed
Enrollment	149
Completion Date	September 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
Gender	All
Age	18 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Not Available

Administrative Information

NCT Number:	NCT00594542
Other Study ID Numbers	UPenn IRB-806101
Has Data Monitoring Committee	Yes
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 Party	Christopher 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