Local Anesthetic Clinical Trial

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: Enrolling by invitation
• Conditions: Anesthesia, Local; Mohs Micrographic Surgery
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride; Drug: Mepivacaine Hydrochloride; Drug: Chlorprocaine; Drug: Lidocaine

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: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	5 mins, 15 mins, 20 mins, 25 mins, 30 mins, 45 mins (reconstruction)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
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.	5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
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.	5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
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.	5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
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.	5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
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.	5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)
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.	5 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes (reconstruction)

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Stan Tolkachjov, MD, Baylor Scott and White Health

Publications and helpful links

General Publications

• 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.
• Phillips, Shay, et al.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Piperidines; Bupivacaine; Lidocaine; Mepivacaine; chloroprocaine
• Other Study ID 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