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Comparison of the Total Dose and Efficacy of Two Lidocaine Concentrations Needed for Cutaneous Surgery Local Anesthesia
This study has been completed.
Sponsored by: University of Pennsylvania
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00594542
  Purpose

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
Anesthesia
Drug: lidocaine

MedlinePlus related topics: Anesthesia
Drug Information available for: Lidocaine Epinephrine Epinephrine bitartrate
U.S. FDA Resources
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

Further study details as provided by University of Pennsylvania:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: June 2007
Study Completion Date: September 2007
Arms Assigned Interventions
0.5% lidocaine group: Experimental
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594542

Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Christopher J Miller, MD University of Pennsylvania Department of Dermatology
  More Information

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

Keywords provided by University of Pennsylvania:
lidocaine
local anesthesia
Mohs micrographic surgery

Study placed in the following topic categories:
Lidocaine
Epinephrine

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Anti-Asthmatic Agents
Cardiovascular Agents
Anesthetics, Local
Pharmacologic Actions
Adrenergic Agonists
Mydriatics
Sensory System Agents
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009