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To compare several local anesthetics when used during dermatological surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | Anesthetics including, bupivacaine, mepivacaine, chlorprocaine |
|
| Standard of Care Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Standard of Care drug |
| |
| Bupivacaine Hydrochloride |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stan Tolkachjov, MD | Baylor Scott and White Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22959232 | Background | 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. | |
| 38048284 |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D002045 | Bupivacaine |
| D008619 | Mepivacaine |
| C004616 | chloroprocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
Study Drug |
|
| Mepivacaine Hydrochloride | Drug | Study Drug |
|
|
| Chlorprocaine | Drug | Study Drug |
|
| 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) |
| 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. |
| 26951939 | 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. |
| 27125530 | 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. |
| Background | Phillips, Shay, et al. |
| 23479720 | 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. |
| 36907555 | 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. |
| Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |