A novel lidocaine hydrochloride ophthalmic gel for topical ocular anesthesia

Hr Shah, E Reichel, Bg Busbee, Hr Shah, E Reichel, Bg Busbee

Abstract

Topical anesthetics play an important role in the practice of ophthalmology, both for procedures in the office and in the operating room. The need for safe, long-acting topical ocular anesthetic agents is ongoing, and has been highlighted by the increase of intravitreal administration of pharmacologic agents. Current practices for ocular anesthesia include subconjunctival injection of 2% aqueous lidocaine, topical 2% lidocaine drops and topical 0.5% tetracaine. Tetracaine is not yet FDA approved, and is associated with corneal epithelial toxicity and delayed epithelial healing after multiple administrations. Lidocaine jelly (2%) preparations have been reported to be beneficial in several systemic procedures, including those of the upper airway, dental, urogenital, and gastrointestinal. It has been theorized, and recent studies support the idea, that gel formulations of lidocaine may enhance anesthetic effect, and therefore be superior to anesthetic solutions for topical cataract surgery. The viscous nature of gel formulations is thought to lengthen contact time, resulting in better anesthesia at lower drug concentrations. Furthermore, several studies suggest that lidocaine is bactericidal and bacteriostatic, and may have a supplementary role in preventing and treating surgical site infections. Akten™, lidocaine 3.5% gel (Akorn, Buffalo Grove, IIlinois) was FDA approved for all ophthalmic procedures in October 2008. This gel is a preservative-free, lidocaine-based anesthetic gel consisting of 35 mg/mL of lidocaine hydrochloride. We describe the properties, including chemical structure, indications, evidence of support, use, adverse effects, and precautions, which we believe enable Akten to provide superior anesthesia, while minimizing side effects.

Keywords: Akten; lidocaine gel; ocular surgery; topical anesthetic.

Figures

Figure 1
Figure 1
Synthesis of lidocaine.

References

    1. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355(14):1419–1431.
    1. Zainudin BM, Rafia MH, Sufarlan AW. Topical nasal anesthesia for fibreoptic bronchoscopy: lidocaine spray or gel? Singapore Med J. 1993;34(2):148–149.
    1. Chan ST, Them CS. The effects of 2% lidocaine gel on incidence of retching with the use of the laryngeal mask airway. Anaesthesia. 1995;50(3):257–258.
    1. Donaldson D, Gelskey SC, Landry RG, Mathews DC, et al. A placebocontrolled multi-centered evaluation of an anaesthetic gel (Oraqix) for periodontal therapy. J Clin Periodontol. 2003;30(3):171–175.
    1. Kalafi H, Cengiz M, Demir N. Intrauterine lidocaine gel application for pain relief during and after hysterosalpingography. Int J Gynaecol Obstet. 2003;83(1):65–67.
    1. Mallick S, Humbert M, Braud F, Fofana M, et al. Local anesthesia before transrectal ultrasound guided prostate biopsy: comparison of 2 methods in a prospective, randomized clinical trial. J Urol. 2004;171:730–733.
    1. Bardocci A, Lofoco G, Perdicaro S, Ciucci F, et al. Lidocaine 2% gel versus lidocaine 4% unpreserved drops for topical anesthesia in cataract surgery: a randomized controlled trial. Ophthalmology. 2003;110(1):144–149.
    1. Soliman MM, Macky TA, Samir MK. Comparative clinical trial of topical anesthetic agents in cataract surgery: lidocaine 2% gel, bupivacaine 0.5% drops, and benoxinate 0.4% drops. J Cataract Refract Surg. 2004;30(8):1716–1720.
    1. Gaynes BI. Lidocaine gel versus drops. Ophthalmology. 2003;110(12):2429–2430.
    1. Irle S, Luckefahr MH, Tho Seeth T. Tetracaine drops versus lidocaine gel for topical anaesthesia in cataract surgery. Klin Monatsbl Augenheillkd. 2003;220(9):625– 628.
    1. Yu CB, Wong VW, Fan DS, Yip WW, et al. Comparison of lidocaine 2% gel versus amethocaine as the as the sole anesthetic agent for strabismus surgery. Ophthalmology. 2003;110(7):1426–1429.
    1. Kwok AK, Young AL, Lam DS. Efficacy of lidocaine gel for outpatient laser treatment in inflamed eyes. Eye. 2001;15:608–611.
    1. Assia EI, Pras E, Yehezkel M, Rotenstreich Y, et al. Topical anesthesia using lidocaine gel for cataract surgery. J Cataract Refract Surg. 1999;25(5):635–639.
    1. Parr AM, Zoutman DE, Davidson JS. Antimicrobial activity of lidocaine against bacteria associated with nosocomial would infection. Ann Plast Surg. 1999;43:239–245.
    1. Stratford AF, Zoutman DE, Davidson JS. Effect of lidocaine and epinephrine on Staphylococcus aureus in a guinea pig model of surgical wound infection. Plast Reconstr Surg. 2002;110:1275–1279.
    1. Noda H, Saionji K, Miyazaki T. Antibacterial activity of local anesthetics. Masui. 1990;39:994–1001.
    1. Sakuragi T, Ishino H, Dan K. Bactericidal activity of clinically used local anesthetics on Staphylococcus aureus. Reg Anesth. 1996;21:239–242.
    1. Aydin ON, Eyigor M, Aydin N. Antimicrobial activity of ropivacaine and other local anaesthetics. Eur J Anaesthesiol. 2001;18:687–694.
    1. Miller JJ, Scott IU, Flynn HW, Jr, Smiddy WE, et al. Endophthalmitis after cataract surgery (2000–2004): incidence, clinical settings, and visual acuity outcomes after treatment. Am J Ophthalmol. 2005;139(6):983–987.
    1. Busbee BG, Alam A, Reichel E. Lidocaine hydrochloride gel for ocular anesthesia: results of a prospective, randomized study. Ophthalmic Surg Lasers Imaging. 2008;39(5):386–390.
    1. Reilly TJ. The preparation of lidocaine. J Chem Ed. 1999;76(11):557.
    1. Catterall WA. Molecular mechanisms of gating and drug block of sodium channels. Novartis Found Symp. 2002;241:206–218.
    1. Barequet IS, Soriano ES, Green WR, O’Brien TP. Provision of anesthesia with a single application of lidocaine 2% gel. J Cataract Refract Surg. 1999;25(5):626–631.
    1. Young AL, Leung GY, Cheng LL, Lau TT, et al. Randomised controlled trial on the effectiveness of lidocaine gel vs tetracaine drops as the sole topical anaesthetic agent for primary pterygium surgery. Eye. 2009;23(7):1518–1523.
    1. Theocharis IP, Alexandridou A, Tomic Z. A two-year prospective study comparing lidocaine 2% jelly versus peribulbar anaesthesia for 25G and 23G sutureless vitrectomy. Graefes Arch Clin Exp Ophthalmol. 2007;245(9):1253–1258.
    1. Friedman SM, Margo CE. Topical gel vs subconjunctival lidocaine for intravitreous injection: a randomized clinical trial. Am J Ophthalmol. 2006;142(5):887–888.
    1. Oksuz H, Tamer C. Pain relief after pterygium surgery with viscous lidocaine. Ophthalmologica. 2006;220(5):323–326.
    1. Kozak I, Cheng L, Freeman WR. Lidocaine gel anesthesia for intravitreal drug administration. Retina. 2005;25(8):994–998.
    1. Thill M, Zeitz O, Richard I, Richard G. Lidocaine gel versus combined topical anesthesia using bupivicaine, oxybuprocaine, and diclofenac eye-drops in cataract surgery. Ophthalmologica. 2005;219(3):167–170.
    1. Rebolleda G, Munoz-Negrete FJ, Gutierrez-Ortiz C. Topical plus intracameral lidocaine versus retrobulbar anesthesia in phacotrabeculectomy: prospective randomized study. J Cataract Refract Surg. 2001;27(8):1214–1220.
    1. Li RT, Lai JS, Ng JS, Law RW, et al. Efficacy of lignocaine 2% gel in chalazion surgery. Br J Ophthalmol. 2003;87(2):157–159.
    1. Zabriskie NA, Ahmed II, Crandall AS, Daines B, et al. A comparison of topical and retrobulbar anesthesia for trabeculectomy. J Glaucoma. 2002;11(4):306–314.
    1. Oksuz H, Tamer C. Efficacy of lidocaine 2% gel in pterygium surgery. Acta Ophthalmol Scand. 2005;83(2):206–209.
    1. Page MA, Fraunfelder FW. Safety, efficicay, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures. Clin Ophthalmol. 2009;3:601–609.
    1. Segev F, Voineskos AN, Hui G, et al. Combined topical and intracameral anesthesia in penetrating keratoplasty. Cornea. 2004;23(4):372–376.

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