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Mohs Micrographic SurgeryPhase 4NCT07601750

Local Anesthetic Clinical Trial

A Phase 4 study testing Lidocaine, Bupivacaine Hydrochloride and Mepivacaine Hydrochloride in people with Mohs Micrographic Surgery and Anesthesia, Local, run by Baylor Research Institute at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

To compare several local anesthetics when used during dermatological surgery. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Mohs Micrographic Surgery, Anesthesia, Local
What is being tested?
Lidocaine, Bupivacaine Hydrochloride and Mepivacaine Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
7 Jan 2025to Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Baylor University Medical Center

    Dallas, Texas, 75246

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Lidocaine, Bupivacaine Hydrochloride, Mepivacaine Hydrochloride, Chlorprocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

    Standard of Care drug

  • Bupivacaine HydrochlorideDrug

    Study Drug

  • Mepivacaine HydrochlorideDrug

    Also called Carbocaine

    Study Drug

  • ChlorprocaineDrug

    Study Drug

Study groups in NCT07601750
Study groupRoleWhat they receive
Treatment GroupActive comparatorAnesthetics including, bupivacaine, mepivacaine, chlorprocaine
Receives: Drug: Bupivacaine Hydrochloride; Drug: Mepivacaine Hydrochloride; Drug: Chlorprocaine
Standard of Care GroupActive comparatorNot described
Receives: Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine if pain increases with local injections at each stage of surgery.

    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.

    Measured: 5 mins, 15 mins, 20 mins, 25 mins, 30 mins, 45 mins (reconstruction)

Secondary outcomes (7)

  1. Pain control using mepivacaine as a primary anesthetic agent

    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.

    Measured: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)

  2. Pain control using bupivacaine with epinephrine as a primary anesthetic agent

    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.

    Measured: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)

  3. Pain control using bupivacaine as a primary anesthetic agent

    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.

    Measured: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)

  4. Ideal anesthetic agents for varying sizes of tumors

    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.

    Measured: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)

  5. Ideal anesthetic agents for varying anatomic location of tumors

    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.

    Measured: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)

  6. Overall tolerability of MMS

    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.

    Measured: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)

  7. General length of time required for various steps of MMS

    Assess the length of time it took to move from one stage to the next.

    Measured: 5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start7 Jan 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07601750
Sponsor's protocol ID
024-296
Status last verified
May 2026
First submitted
4 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ad Hoc Task Force; Connolly SM, Baker DR, Coldiron BM, Fazio MJ, Storrs PA, Vidimos AT, Zalla MJ, Brewer JD, Smith Begolka W; Ratings Panel; Berger TG, Bigby M, Bolognia JL, Brodland DG, Collins S, Cronin TA Jr, Dahl MV, Grant-Kels JM, Hanke CW, Hruza GJ, James WD, Lober CW, McBurney EI, Norton SA, Roenigk RK, Wheeland RG, Wisco OJ. AAD/ACMS/ASDSA/ASMS 2012 appropriate use criteria for Mohs micrographic surgery: a report of the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. J Am Acad Dermatol. 2012 Oct;67(4):531-50. doi: 10.1016/j.jaad.2012.06.009. Epub 2012 Sep 5.

    PubMed 22959232

  • Navrazhina K, Shah K, Rigo R, Shochat T, Minkis K. Anatomic Location Influences Duration of Local Lidocaine Anesthesia in Dermatologic Surgery. Dermatol Surg. 2024 Feb 1;50(2):155-159. doi: 10.1097/DSS.0000000000004012. Epub 2023 Nov 27.

    PubMed 38048284

  • Kouba DJ, LoPiccolo MC, Alam M, Bordeaux JS, Cohen B, Hanke CW, Jellinek N, Maibach HI, Tanner JW, Vashi N, Gross KG, Adamson T, Begolka WS, Moyano JV. Guidelines for the use of local anesthesia in office-based dermatologic surgery. J Am Acad Dermatol. 2016 Jun;74(6):1201-19. doi: 10.1016/j.jaad.2016.01.022. Epub 2016 Mar 4.

    PubMed 26951939

  • Connolly KL, Nehal KS, Dusza SW, Rossi AM, Lee EH. Assessment of intraoperative pain during Mohs micrographic surgery (MMS): An opportunity for improved patient care. J Am Acad Dermatol. 2016 Sep;75(3):590-594. doi: 10.1016/j.jaad.2016.02.1230. Epub 2016 Apr 25.

    PubMed 27125530

  • Phillips, Shay, et al.

  • Moran TC, Kaye AD, Mai AH, Bok LR. Sedation, analgesia, and local anesthesia: a review for general and interventional radiologists. Radiographics. 2013 Mar-Apr;33(2):E47-60. doi: 10.1148/rg.332125012.

    PubMed 23479720

  • Dirr MA, Christensen RE, Anvery N, Nadir U, Schaeffer M, Veledar E, Minkis K, Nodzenski M, Whittington A, Brieva JC, Tung R, Poon E, Alam M. Pain of local anesthetic injection of lidocaine during subsequent stages of Mohs micrographic surgery: A multicenter prospective cohort study. J Am Acad Dermatol. 2023 Jul;89(1):114-118. doi: 10.1016/j.jaad.2023.02.049. Epub 2023 Mar 10.

    PubMed 36907555

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine, Bupivacaine Hydrochloride and Mepivacaine Hydrochloride in people with Mohs Micrographic Surgery and Anesthesia, Local, run by Baylor Research Institute at 1 site in United States.

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 2 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: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07601750, which also lists 7 linked publications.

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 22 May 2026.

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