NCT00594542

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

First QC Date

January 2, 2008

Last Update Submit

November 28, 2023

Conditions

Anesthesia

Keywords

lidocainelocal anesthesiaMohs micrographic surgery

Outcome Measures

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.

    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.

    One day

Study Arms (2)

0.5% lidocaine group

EXPERIMENTAL

Group that receives 0.5% lidocaine with 1:200,000 epinephrine

Drug: lidocaine

1.0% lidocaine group

EXPERIMENTAL

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

Drug: lidocaine

Interventions

lidocaineDRUG

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

0.5% lidocaine group1.0% lidocaine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Mohs micrographic surgery patient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Christopher J Miller, MD

    University of Pennsylvania Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 15, 2008

Study Start

June 1, 2007

Study Completion

September 1, 2007

Last Updated

November 29, 2023

Record last verified: 2023-11