Lidocaine Clinical Trial
Official title:
Comparing the Efficacy of Local Anesthetics in Mohs Surgery
Mohs surgery is a very effective option in removing non-melanoma skin cancers, as the tissue
being removed is analyzed the same day. If there are remnants of cancer cells in the tissue
removed, the Mohs surgeon will go back and remove further tissue and repair the surgical
wound all within the same day.
Unfortunately, postoperative pain is quite prevalent among patients requiring Mohs
procedures, as up to 52% require an additional oral pain medication. Lidocaine is the most
commonly used anesthetic used in Mohs given its rapid onset of action. However, the duration
of lidocaine's effect is much shorter than bupivacaine, which may translate into increased
postoperative pain.
To date, there are no specific studies comparing bupivacaine alone, lidocaine alone or both
in conjunction in Mohs procedures.
The investigators predict bupivacaine alone and bupivacaine used in conjunction with
lidocaine are more effective in managing pain during Mohs surgery than lidocaine alone.
To test our hypothesis, the investigators plan to have 105 patients receive either lidocaine
alone, bupivacaine alone, or lidocaine and bupivacaine in conjunction during their Mohs
procedure. Pain will be evaluated at various time points throughout the surgery.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | June 14, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age = 18 years 2. Confirmed diagnosis of non-melanoma skin cancer 3. Written informed consent Exclusion Criteria: 1. Documented or reported history of adverse reaction to lidocaine or bupivacaine 2. Active soft tissue infection at site of surgery 3. Participants who require more than 3 stages of excision |
Country | Name | City | State |
---|---|---|---|
Canada | Mohs Surgery Clinic | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | Benefactor Life Members’ Research Grant, Richard J. MacKay Endowment Fund, The Ottawa Hospital Division of Dermatology |
Canada,
Bouloux GF, Punnia-Moorthy A. Bupivacaine versus lidocaine for third molar surgery: a double-blind, randomized, crossover study. J Oral Maxillofac Surg. 1999 May;57(5):510-4; discussion 515. — View Citation
Christensen J, Matzen LH, Vaeth M, Wenzel A, Schou S. Efficiency of bupivacaine versus lidocaine and methylprednisolone versus placebo to reduce postoperative pain and swelling after surgical removal of mandibular third molars: a randomized, double-blinde — View Citation
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. — View Citation
Kaurich MJ, Otomo-Corgel J, Nagy RJ. Comparison of postoperative bupivacaine with lidocaine on pain and analgesic use following periodontal surgery. J West Soc Periodontol Periodontal Abstr. 1997;45(1):5-8. — View Citation
Koay J, Orengo I. Application of local anesthetics in dermatologic surgery. Dermatol Surg. 2002 Feb;28(2):143-8. Review. — View Citation
Markovic AB, Todorovic L. Postoperative analgesia after lower third molar surgery: contribution of the use of long-acting local anesthetics, low-power laser, and diclofenac. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Nov;102(5):e4-8. Epub 2006 — View Citation
Su N, Liu Y, Yang X, Shi Z, Huang Y. Efficacy and safety of mepivacaine compared with lidocaine in local anaesthesia in dentistry: a meta-analysis of randomised controlled trials. Int Dent J. 2014 Apr;64(2):96-107. doi: 10.1111/idj.12087. Epub 2014 Jan 16 — View Citation
Tetzlaff JE. The pharmacology of local anesthetics. Anesthesiol Clin North Am. 2000 Jun;18(2):217-33, v. Review. — View Citation
Thomson CJ, Lalonde DH. Randomized double-blind comparison of duration of anesthesia among three commonly used agents in digital nerve block. Plast Reconstr Surg. 2006 Aug;118(2):429-32. — View Citation
Yilmaz YF, Ozlugedik S, Titiz A, Tuncay A, Ozcan M, Unal A. Comparison of levo-bupivacaine and lidocaine for postoperative analgesia following septoplasty. Rhinology. 2008 Dec;46(4):289-91. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wong-Baker FACES Pain Rating Scale | The Wong-Baker Pain Scale is a validated tool used around the world for to quantify patients amount of pain. The score ranges from 0 (no pain) to 10 (worst pain). | 2, 4, 6, 8, 12, 24, 36, and 72 hours | |
Secondary | Adverse Event | Adverse event to local anesthetic | 1 week post-op | |
Secondary | Post-Operative Infection | Post-operative infection requiring topical or systemic antibiotics | 1 week post-op | |
Secondary | Post-Operative Bleeding | Post-operative bleeding requiring surgical exploration/revision or hematoma evacuation | 1 week post-op |
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