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(12) United States Patent (10) Patent No.: US 8,828,452 B2 Abrahmsohn (45) Date of Patent: Sep

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(12) United States Patent (10) Patent No.: US 8,828,452 B2 Abrahmsohn (45) Date of Patent: Sep USOO8828452B2 (12) United States Patent (10) Patent No.: US 8,828,452 B2 Abrahmsohn (45) Date of Patent: Sep. 9, 2014 (54) METHOD FOR PAIN CONTROL Fiscella, R.G., et al., Cocaine Hydrochloride Topical Solution Pre pared for Ophthalmic Use, American Journal of Hospital Pharmacy, (76) Inventor: Glenn Abrahmsohn, Key Biscayne, FL 50: 1572-1574 (1993). (US) Houle, G.L., et al., A Comparison Between Lignocaine-Carbon Dioxide Base for Epidural Anaesthesia During Vaginal Delivery, (*) Notice: Subject to any disclaimer, the term of this British Journal of Anaesthia, 43(2): 1145-1148 (1971). patent is extended or adjusted under 35 Johnson, Mark D. et al., Reversal of Bupivacaine Epidural U.S.C. 154(b) by 628 days. Enesthesia by Intermittent Epidural Injections of Crystalloid Solu tions, Anesth. Analg. 70:395-399 (1990). Jones, S.E.F., et al., Anaesthesia for Insertion of Bone-Anchored (21) Appl. No.: 12/275,056 Hearing Aids in Children: A 7-Year Audit, Anaesthesia, 56: 777-798 (2001). (22) Filed: Nov. 20, 2008 Klein, Jeffrey A., Anesthetic Formulation of Tumescent Solutions, Dermatologics Clinics, 17(4):751-759 (1999). (65) Prior Publication Data Lam, D.T. et al., Extension of Epidural Blockade in Labour for US 2010/O124575A1 May 20, 2010 Emergency Caesarean Section Using 2% Lidocaine with Epineph rine and Fentanyl. With or Without Alkalinisation, Anaesthesia, 56:777-798 (2001). Related U.S. Application Data Manka, R.L., et al., Sodium Bicarbonate Reduces Pain Associated (63) Continuation-in-part of application No. 12/124,781, with Ophthalmic Nerve Blocks, Retractive & Corneal Surgery, filed on May 21, 2008. 7: 186-187 (1991). McKay, Warren, et al., Sodium Bicarbonate Attenuates Pain on Skin (60) Provisional application No. 60/939,540, filed on May Infiltration with Lidocaine, with or without Epinephrine, Anesth. 22, 2007. Analg. 66:572-4 (1987). Metzinger, Stephen E., et al., Local Anesthesia in Rhinoplasty: A (51) Int. Cl. New Twist?, ENT Journal, 71 (8):405-406 (1992). AOIN 59/00 (2006.01) Metzinger, Stephen E. et al., Local Anesthesia in Blepharoplasty: A A6 IK33/00 (2006.01) New Look?, South Med. J., 87(2): 225-7 (1994). Milner, Q.J.W., et al., Alkalinization of Amide Local Anaesthetics by A6 IK 45/06 (2006.01) Addition of 1% Sodium Bicarbonate Solution, European Journal of A6 IK3I/67 (2006.01) Anaesthesiology, 17:38-42 (2000). (52) U.S. Cl. Peterfreund, Robert A., pHAdjustment of Local Anesthetic Solutions CPC ................. A61 K33/00 (2013.01); A61K 45/06 with Sodium Bicarbonate: Laboratory Evaluation of Alkalinization (2013.01); A61 K3I/I67 (2013.01) and Precipitation, Reg. Anesth., 14(6):265-10 (1989). USPC ........................................... 424/717:424/715 Ririe, D.G., et al., Effect of Alkalinization of Lidocaine on Median Nerve Block, British Journal of Anaesthesia, 84(2):163–8 (2000). (58) Field of Classification Search Sakura, S., et al., Quantitative and Selective Assessment of Sensory CPC ............................. A61K 31/167; A61 K33/00 Block During Lumbar Epidural Anaesthesia with 1% or 2% USPC .................................................. 424/717, 715 Lidocaine, British Journal of Anaesthesia, 81(5): 718-722 (1998). See application file for complete search history. Sakura, S., et al., Recurrent Neurological Symptoms in a Patient Following Repeat Combined Spinal and Epidural Anaesthesia, (56) References Cited 88(1): 141-143 (2002). Sinnott, Catherine J., et al., Addition of Sodium Bicarbonate to U.S. PATENT DOCUMENTS Lidocaine Decreases the Duration of Peripheral Nerve Block in the Rat, Anesthesiology, 93(4): 1045-1052 (2000). 5, 192,527 A * 3/1993 Abrahmsohn ................ 424,678 Steinbrook, Richard A., et al., Effects of Alkalinization of Lidocaine 5,209.724. A * 5/1993 Dhaliwal et al. .............. 424,686 5,693,312 A 12/1997 Stroppolo et al. on the Pain of Skin Infiltration and Intravenous Catheterization, J. 2005/02340 13 A1* 10, 2005 Parsons ........................... 514/54 Clin. Anesth., 5:456-458 (1993). (Continued) FOREIGN PATENT DOCUMENTS Primary Examiner — Gina C Justice WO 93,00932 A1 1, 1993 Assistant Examiner — Genevieve S Alley OTHER PUBLICATIONS (74) Attorney, Agent, or Firm —Ted Whitlock; Richard Dulik Nielsen et al. (Eur, J. Pharm. Sci. 2005, 24, 433-440).* Acosta, Alvaro E., et al., Clinical Parameters of Tumescent Anesthe (57) ABSTRACT sia in Skin Cancer Reconstructive Surgery, Arch Dermatol., 133:451 454 (1997). Methods for providing post-operative pain control or relief to Armel, Harvey E., et al., Alkalinization of Local Anesthesia With a patient are disclosed. Methods include, for example, admin Sodium Bicarbonate—Preferred Method of Local Anesthesia, Urol istering bicarbonate to an area of a patient during a Surgical or ogy, 43(1): 101 (1994). dental procedure, near completion of a Surgical or dental Arndt, Kenneth A. et al., Minimizing the Pain of Local Anesthesia, procedure or immediately following a Surgical or dental pro Plastic and Reconstructive Surgery, 72(5):676-679 (1983). Bonhomme, Laurence, et al., Stability of Epinephrine in Alkalinized cedure, in an area previously administered or containing a Solutions, Annals of Emergency Medicine, 19(11): 1242/31-1244/33 regional or local anesthetic in an amount Sufficient to provide (1990). the patient with pain control or relief for a period of time after Christoph, Richard A. et al., Pain Reduction in Local Anesthetic the Surgical or dental procedure. Administration Through pH Buffering, Annals of Emergency Medi cine, 17(2): 117/27-121/31 (1988). 32 Claims, 1 Drawing Sheet US 8,828.452 B2 Page 2 (56) References Cited Martin, R., et al., Effects of Carbon Dioxide and Epineprine of Serum Levels of Lidocaine After Epidural Anaesthesia, Canad. Anaesth. OTHER PUBLICATIONS Soc. J., 1981, 28:224-227. Stewart, James H., et al., Neutralized Lidocaine with Epinephrine for McKay, W., et al., Sodium Bicarbonate Attenuates Pain on Skin Local Anesthesia, J. Dermatol. Surg. Oncol. 15: 1081-1083 (1989). Infiltration with Lidocaine, with or without Epinephrine, Anesth. Zahl, Kenneth, et al., pH-Adjusted Bupivaccaine and Hyaluronidase Analg., 1987, 66:572-4. for Peribulbar Block, Anesthesiology, 72:230-232 (1990). Carvalho, et al., Local Infiltration of Epinephrine-Containing Ritchie, J.M., et al., On the Mode of Action of Local Anesthetics, Lidocaine with Biocarbonate Reduces Superficial Bleeding and Pain 1966, Annu. Rev. Pharmacol. 6:405-430. During Labor Epidural Catheter Insertion: A Randomized Trial, Ritchie, J.M., et al., The Active Structure of Local Anesthetics, The International Journal of Obstetric Anesthesia, 2007, 16:116-121. Journal of Pharmacology and Experimental Therapeutics, 1965, Wong, etal. On the Mechanisms of Potentiation of Local Anesthetics 150: 152-159. by Biocarbonate Buffer: Drug Structure-Activity Studies on Isolated Shinider, S.M., et al., The Kinetics of Transfer of Lidocaine Peripheral Nerve, Anes. Analg., 1993, 76: 131-143. (Xylocaine) Across the Human Placenta, Anesthesiology, 1968, Br?u, M.E., et al., Local Anesthetics Potently Block a Potential 29:944-950. Insensitive Potassium Channel in Myelinated Nerve, J. Gn. Physiol. Strobel, G.E., et al., The Effects of pH Gradients on the Action of 1995, 105:485-505. Procaine and Lidocaine in Intact and Desheathed Sciatic Nerves, The Christoph, R.A., et al., Pain Reduction in Local Anesthetic Admin Journal of Pharmacology and Experimental Therapeutics, 1970, istration Through pH Buffering, Annals of Emergency Medicine, 172:1-17. 1988, 17:117/27-30/120. Buckley, F.P. et al., Acid and Alkaline Solutions of Local Anesthet Conouris, G.A., et al., Potentiation of the Nerve-Depressant Effect of ics: Duration of Nerve Block and Tissue pH. Anesth. Analg., 1985, Local Anaesthetics by Carbon Dioxide, Nature, 1964. 204:57-59. 64:477-82. Difazio, C.A., et al., Comparison of pH-Adjusted Lidocaine Solu Buckley, F.P. et al., pH of Solution and Duration of Local Anesthetic tions for Epidural Anesthesia, Anesth. Analg., 1986, 65.760-4. Block, Regional Anesthesia, 1983, 8:36. Galindo, A., pH-Adjusted Local Anesthestics: Clinical Experience, Regional Anestheria, 1983, 8:35-36. * cited by examiner US 8,828,452 B2 1. 2 METHOD FOR PAIN CONTROL The methods of the invention include methods that provide or extend pre- or post-operative pain (chronic or acute) con RELATED APPLICATIONS trol. Thus, for example, in various aspects of the invention, an inorganic or organic salt agent (e.g., bicarbonate) Such as a This application is a continuation-in-part of U.S. applica bicarbonate (e.g., sodium bicarbonate, 4.8%, pH 7.8-8.2) or tion Ser. No. 12/124,781, filed May 21, 2008, which claims buffered phosphated nitrated salt, is administered to a patient the benefit of priority to U.S. provisional application No. in need of pain control or extension of pain control that has 60/939,540, filed May 22, 2007, all of which applications are been administered a regional or local anesthetic. The methods expressly incorporated herein by reference. of the invention may also be practiced during a Surgical or 10 dental procedure, near completion of a Surgical or dental INTRODUCTION procedure or immediately following a Surgical or dental pro cedure. Thus, for example, in various aspects of the invention, Anesthetic agents are pharmacologically active agents that a patient is provided with or extended pain (chronic or acute) block nerve conduction when applied in therapeutically control during a Surgical or dental procedure or following a effective amounts. Anesthetics can be used for local, regional 15 Surgical or dental procedure by appropriate administration of or systemic application. Anesthetics may be applied by injec an inorganic or organic salt agent (e.g., bicarbonate). tion, ointments, jellies, pastes, topical Solutions and Suspen DESCRIPTION OF DRAWING sions or other forms. FIG. 1 shows a schematic diagram of a proposed mecha SUMMARY OF THE INVENTION nism. The invention is based in part on a regional or local anes DETAILED DESCRIPTION OF THE INVENTION thesia that can be converted to extendor provide pain (chronic or acute) control or relief.
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