Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
174 participants
INTERVENTIONAL
2020-07-30
2021-09-30
Brief Summary
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Detailed Description
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MMS is generally well tolerated, but post-operative pain is common. Pain peaks on the day of surgery and slowly declines in subsequent days. Risk factors for increased pain may include flap or graft repair type, location on scalp, lip, nose, or ear, younger age, and increased number of lesions treated. Post-operative pain medication is not standardized in dermatological surgery, but often includes non-narcotic analgesics including acetaminophen and ibuprofen, and less commonly narcotic analgesics such as tramadol and oxycodone. Given the current national trend to reduce opioid use, a multimodal approach to pain management has been adopted by many surgical specialties to optimize analgesia perioperatively.
The most commonly used anesthetic in MMS is local subcutaneous infiltration of lidocaine 0.5 - 2% with 1:100,000 - 1:200,000 epinephrine. Lidocaine is quick-acting, can be buffered to reduce injection pain, and is well tolerated, but the duration of action is only two hours, making it less effective for post-operative pain. Bupivacaine with epinephrine has a longer duration of action compared to lidocaine (up to four hours), but it is rarely used alone due to slower onset of action and more painful injection compared with lidocaine. Bupivacaine is used in many other surgical specialties, including general, plastic, and orthopedic surgery, as a peri-operative adjuvant and has been shown to reduce post-operative opioid use. It is generally well tolerated, carrying a class-effect risk of cardiac toxicity in high doses as does lidocaine, but has been shown to be safe in dermatologic surgery when used for wound infiltration. A newer formulation of liposomal bupivacaine has been shown to be even longer lasting and safer, with pain control up to 72 hours and no reported cardiac toxicity. In addition, a recent study has showed subcutaneous infiltration of bupivacaine with epinephrine to be an effective intra-operative pain adjuvant during MMS compared to lidocaine alone.
Pain control post-operatively in MMS may be optimized by including bupivacaine injections at the end of the surgical procedure given its long-lasting anesthetic effects. There are currently no studies addressing the use of bupivacaine as an adjuvant to control post-operative pain during MMS. The investogators propose a prospective randomized controlled trial to evaluate the effectiveness of bupivacaine injection at the conclusion of surgery for reducing post-operative pain and analgesic use.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bupivicaine
Scalp flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc, Ear flap or wedge repair: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Nose flap, 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc. Split volume between nose and donor site for melolabial interpolated flap Paramedian forehead flap: 5cc split between forehead donor site and nasal recipient site: 4cc forehead, 1cc nose Cartilage alar-batten graft (ear donor site) 1cc at auricular donor site in addition to bupivacaine used for nasal reconstruction, if any, that qualifies above Cheek Mustarde flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Lip flap, wedge repair, Abbe flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc
Bupivacaine
Scalp flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc, Ear flap or wedge repair: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Nose flap, 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc. Split volume between nose and donor site for melolabial interpolated flap Paramedian forehead flap: 5cc split between forehead donor site and nasal recipient site: 4cc forehead, 1cc nose Cartilage alar-batten graft (ear donor site) 1cc at auricular donor site in addition to bupivacaine used for nasal reconstruction, if any, that qualifies above Cheek Mustarde flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Lip flap, wedge repair, Abbe flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc
Placebo saline
Saline in the same volume as described above for bupivicaine
Placebo Saline
Scalp flap: 2.5cc salinefor 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc, Ear flap or wedge repair: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Nose flap, 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc. Split volume between nose and donor site for melolabial interpolated flap Paramedian forehead flap: 5cc split between forehead donor site and nasal recipient site: 4cc forehead, 1cc nose Cartilage alar-batten graft (ear donor site) 1cc at auricular donor site in addition to saline used for nasal reconstruction, if any, that qualifies above Cheek Mustarde flap: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Lip flap, wedge repair, Abbe flap: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc
Interventions
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Bupivacaine
Scalp flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc, Ear flap or wedge repair: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Nose flap, 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc. Split volume between nose and donor site for melolabial interpolated flap Paramedian forehead flap: 5cc split between forehead donor site and nasal recipient site: 4cc forehead, 1cc nose Cartilage alar-batten graft (ear donor site) 1cc at auricular donor site in addition to bupivacaine used for nasal reconstruction, if any, that qualifies above Cheek Mustarde flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Lip flap, wedge repair, Abbe flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc
Placebo Saline
Scalp flap: 2.5cc salinefor 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc, Ear flap or wedge repair: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Nose flap, 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc. Split volume between nose and donor site for melolabial interpolated flap Paramedian forehead flap: 5cc split between forehead donor site and nasal recipient site: 4cc forehead, 1cc nose Cartilage alar-batten graft (ear donor site) 1cc at auricular donor site in addition to saline used for nasal reconstruction, if any, that qualifies above Cheek Mustarde flap: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Lip flap, wedge repair, Abbe flap: 2.5cc saline for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc
Eligibility Criteria
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Inclusion Criteria
b. Surgical procedure must include one of the following:
1. Scalp rotation/transposition/advancement flap
2. Ear rotation/transposition/advancement/interpolation flap or wedge repair
3. Nose rotation/transposition/advancement/interpolation flap, cartilage alar-batten graft (ear donor site)
4. Cheek Mustarde flap
5. Lip rotation/transposition/advancement flap, wedge repair, Abbe flap
Exclusion Criteria
1. be pregnant or breastfeeding
2. be taking scheduled narcotic medications
3. use narcotics as a drug of abuse
4. have an allergy to bupivacaine or other amide anesthetics
5. have a contraindication to tramadol
6. have been given narcotic pain medications during the Mohs procedure or subsequent reconstruction
7. have multiple surgical sites treated on the same day
18 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
Columbia University
OTHER
University of Missouri-Columbia
OTHER
Responsible Party
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Nicholas J Golda
Professor, Dermatology
Principal Investigators
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Nicholas J Golda, MD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri School of Medicine
Locations
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University of Missouri-Columbia
Columbia, Missouri, United States
Countries
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References
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Tolkachjov SN, Brodland DG, Coldiron BM, Fazio MJ, Hruza GJ, Roenigk RK, Rogers HW, Zitelli JA, Winchester DS, Harmon CB. Understanding Mohs Micrographic Surgery: A Review and Practical Guide for the Nondermatologist. Mayo Clin Proc. 2017 Aug;92(8):1261-1271. doi: 10.1016/j.mayocp.2017.04.009.
Saco M, Golda N. Postoperative Pain Management in Dermatologic Surgery: A Systematic Review. Dermatol Clin. 2019 Jul;37(3):341-348. doi: 10.1016/j.det.2019.03.004. Epub 2019 Apr 16.
Saco M, Golda N. Optimal timing of postoperative pharmacologic pain control in Mohs micrographic surgery: A prospective cohort study. J Am Acad Dermatol. 2020 Feb;82(2):495-497. doi: 10.1016/j.jaad.2019.07.077. Epub 2019 Jul 30. No abstract available.
Roy CF, Azzi AJ, Davison P. A Review of Wound Infusion With Local Anesthetics in Plastic Surgery. Ann Plast Surg. 2019 Dec;83(6):e110-e117. doi: 10.1097/SAP.0000000000001916.
Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
Chen P, Smith H, Vinciullo C. Bupivacaine as an Adjunct to Lidocaine in Mohs Micrographic Surgery: A Prospective Randomized Controlled Trial. Dermatol Surg. 2018 May;44(5):607-610. doi: 10.1097/DSS.0000000000001385.
Merritt BG, Lee NY, Brodland DG, Zitelli JA, Cook J. The safety of Mohs surgery: a prospective multicenter cohort study. J Am Acad Dermatol. 2012 Dec;67(6):1302-9. doi: 10.1016/j.jaad.2012.05.041. Epub 2012 Aug 11.
Limthongkul B, Samie F, Humphreys TR. Assessment of postoperative pain after Mohs micrographic surgery. Dermatol Surg. 2013 Jun;39(6):857-63. doi: 10.1111/dsu.12166. Epub 2013 Mar 6.
Firoz BF, Goldberg LH, Arnon O, Mamelak AJ. An analysis of pain and analgesia after Mohs micrographic surgery. J Am Acad Dermatol. 2010 Jul;63(1):79-86. doi: 10.1016/j.jaad.2009.10.049.
Sniezek PJ, Brodland DG, Zitelli JA. A randomized controlled trial comparing acetaminophen, acetaminophen and ibuprofen, and acetaminophen and codeine for postoperative pain relief after Mohs surgery and cutaneous reconstruction. Dermatol Surg. 2011 Jul;37(7):1007-13. doi: 10.1111/j.1524-4725.2011.02022.x. Epub 2011 May 11.
Evans T, Nicholas TA, Sutton AV, Wysong A. How We Do It: Postoperative Pain Control in Mohs Micrographic Surgery. Dermatol Surg. 2021 Feb 1;47(2):280-282. doi: 10.1097/DSS.0000000000002279. No abstract available.
Lovich-Sapola J, Smith CE, Brandt CP. Postoperative pain control. Surg Clin North Am. 2015 Apr;95(2):301-18. doi: 10.1016/j.suc.2014.10.002. Epub 2015 Jan 24.
Park KK, Sharon VR. A Review of Local Anesthetics: Minimizing Risk and Side Effects in Cutaneous Surgery. Dermatol Surg. 2017 Feb;43(2):173-187. doi: 10.1097/DSS.0000000000000887.
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.
Sorenson E, Chesnut C. Liposomal Bupivacaine: A Review and Applications to Dermatologic Surgery. Dermatol Surg. 2019 Jan;45(1):68-73. doi: 10.1097/DSS.0000000000001628. No abstract available.
Related Links
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Bupivicaine drug insert
Other Identifiers
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2022277
Identifier Type: -
Identifier Source: org_study_id