Local Anesthetic Clinical Trial

NCT07601750 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 024-296
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

To compare several local anesthetics when used during dermatological surgery.

Conditions

Mohs Micrographic Surgery; Anesthesia, Local

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

• Pain control using mepivacaine as a primary anesthetic agent

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

• Pain control using bupivacaine with epinephrine as a primary anesthetic agent

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

• Pain control using bupivacaine as a primary anesthetic agent

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

• Ideal anesthetic agents for varying sizes of tumors

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

• Ideal anesthetic agents for varying anatomic location of tumors

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

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

Anesthetics including, bupivacaine, mepivacaine, chlorprocaine

Drug: Bupivacaine Hydrochloride; Drug: Mepivacaine Hydrochloride; Drug: Chlorprocaine

Standard of Care Group

ACTIVE COMPARATOR

Drug: Lidocaine

Interventions

Lidocaine DRUG

Standard of Care drug

Standard of Care Group

Bupivacaine Hydrochloride DRUG

Study Drug

Treatment Group

Mepivacaine Hydrochloride DRUG

Study Drug

Also known as: Carbocaine

Treatment Group

Chlorprocaine DRUG

Study Drug

Treatment Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (7)

• 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.

  PMID: 22959232 BACKGROUND

• 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.

  PMID: 38048284 BACKGROUND

• 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.

  PMID: 26951939 BACKGROUND

• 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.

  PMID: 27125530 BACKGROUND

• Phillips, Shay, et al.

  BACKGROUND

• 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.

  PMID: 23479720 BACKGROUND

• 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.

  PMID: 36907555 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Bupivacaine; Mepivacaine; chloroprocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stan Tolkachjov, MD

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 22, 2026
• Study Start: January 7, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)