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Completed

NCT Number: NCT00594542

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

Each group is the appropriate concentration of lidocaine with epinephrine for local anesthesia at the beginning of each Mohs stage and the reconstruction.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study 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

Important dates

Study start
2007
Study completion
2007
First posted
Jan 15, 2008
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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