AnesthesiaNCT00594542
Comparison of the Total Dose and Efficacy of Two Lidocaine Concentrations Needed for Cutaneous Surgery Local Anesthesia
A study testing lidocaine in people with Anesthesia, run by University of Pennsylvania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Mohs micrographic surgery patient
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- lidocaine
- Keywords
- lidocaine, local anesthesia, Mohs micrographic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
Each group is the appropriate concentration of lidocaine with epinephrine for local anesthesia at the beginning of each Mohs stage and the reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| 0.5% lidocaine group | Experimental | Group that receives 0.5% lidocaine with 1:200,000 epinephrine Receives: Drug: lidocaine |
| 1.0% lidocaine group | Experimental | Group that receives 1.0% lidocaine with 1:100,000 epinephrine Receives: Drug: lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJun 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- Christopher J Miller, MD, Principal investigator, University of Pennsylvania Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594542
- Sponsor's protocol ID
- UPenn IRB-806101
- Status last verified
- Nov 2023
- First submitted
- 2 Jan 2008
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00594542
- Acronym / sponsor ID
- UPenn IRB-806101
- Conditions
- Anesthesia
- Keywords
- lidocaine, local anesthesia, Mohs micrographic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5% lidocaine group | Experimental | Drug: lidocaineGroup that receives 0.5% lidocaine with 1:200,000 epinephrine |
| 1.0% lidocaine group | Experimental | Drug: lidocaineGroup that receives 1.0% lidocaine with 1:100,000 epinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Mohs micrographic surgery patient
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaineEach group is the appropriate concentration of lidocaine with epinephrine for local anesthesia at the beginning of each Mohs stage and the reconstruction. | Drug | 0.5% lidocaine group, 1.0% lidocaine group |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Miller, MD principal investigator
University of Pennsylvania Department of Dermatology
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine in people with Anesthesia, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.