Local Anesthetic Clinical Trial

May 19, 2026 updated by: Baylor Research Institute

Incidence of Pain During Reanesthetization in Mohs Micrographic Surgery Using Lidocaine, Bupivacaine, Chlorprocaine or Mepivacaine: A Multicenter, Randomized Controlled Trial

To compare several local anesthetics when used during dermatological surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a randomized, controlled trial comparing the effectiveness of several local anesthetics, including lidocaine, mepivacaine, bupivacaine, and chlorprocaine when used for Mohs Microscopic Surgery (MMS) to see which is the most effective.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adults 18-89 years old
  • individuals with a cutaneous tumor treated by MMS

Exclusion Criteria:

  • individuals younger than 18 and older than 89
  • pregnant individuals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard of Care Group
Drug: Lidocaine
Standard of Care drug
Active Comparator: Treatment Group
Anesthetics including, bupivacaine, mepivacaine, chlorprocaine
Drug: Bupivacaine Hydrochloride
Study Drug
Drug: Mepivacaine Hydrochloride
Study Drug
Other Names:
  • Carbocaine
Drug: Chlorprocaine
Study Drug

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine if pain increases with local injections at each stage of surgery.
Time Frame: 5 mins, 15 mins, 20 mins, 25 mins, 30 mins, 45 mins (reconstruction)
Assess changes in pain levels by determining if longer acting agents such as bupivacaine or bupivacaine with epinephrine will show lower reported pain scores by patients compared to shorter acting anesthetic agents such as lidocaine with epinephrine or mepivacaine when undergoing Mohs micrographic surgery. Patients will rate their pain verbally using the visual analog scale (VAS) of 1-10, where 1 is no pain and 10 is worst pain possible.
5 mins, 15 mins, 20 mins, 25 mins, 30 mins, 45 mins (reconstruction)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain control using mepivacaine as a primary anesthetic agent
Time Frame: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Determine if using mepivacaine as the primary anesthetic will lower the patient verbally reported pain scores. Patients will rate their pain verbally using the visual analog scale (VAS) of 1-10, where 1 is no pain and 10 is worst pain possible.
5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Pain control using bupivacaine with epinephrine as a primary anesthetic agent
Time Frame: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Determine change in patients verbally reported pain scale when using bupivacaine with epinephrine as the primary anesthetic. Patients will rate their pain verbally using the visual analog scale (VAS) of 1-10, where 1 is no pain and 10 is worst pain possible.
5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Pain control using bupivacaine as a primary anesthetic agent
Time Frame: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Determine change in patients verbally reported pain scale when using bupivacaine as the primary anesthetic. Patients will rate their pain verbally using the visual analog scale (VAS) of 1-10, where 1 is no pain and 10 is worst pain possible.
5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Ideal anesthetic agents for varying sizes of tumors
Time Frame: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Determine which anesthetic works best for different size tumors. This will be measured using pain scores throughout the procedure prior to taking the stage as the patient will be numb after the stage is taken. The visual analog scale (VAS) of 1-10 will be used, where 1 means no pain and 10 is worst pain possible.
5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Ideal anesthetic agents for varying anatomic location of tumors
Time Frame: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Determine which anesthetic works best for tumors in different locations of the body. This will be measured using pain scores throughout the procedure prior to taking the stage as the patient will be numb after the stage is taken. The visual analog scale (VAS) of 1-10 will be used, where 1 means no pain and 10 is worst pain possible.
5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Overall tolerability of MMS
Time Frame: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Assess patients ability to tolerate the surgery with different anesthetics. This will be measured using pain scores throughout the procedure prior to taking the stage as the patient will be numb after the stage is taken. The visual analog scale (VAS) of 1-10 will be used, where 1 means no pain and 10 is worst pain possible.
5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
General length of time required for various steps of MMS
Time Frame: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
Assess the length of time it took to move from one stage to the next.
5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stan Tolkachjov, MD, Baylor Scott and White Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 024-296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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