The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain.

Summary

This is a randomized, double-blinded, placebo-controlled, cross-over trial examining the effect of a series of two weekly intravenous infusions of lidocaine 4 mg/kg and ketamine 0.2 mg/kg in patients with moderate to severe opioid-refractory chronic cancer-related pain. The aim of this study is to investigate whether the lidocaine - ketamine (LK) regimen provides better analgesia that an active placebo of midazolam 0.02 mg/kg, in this population.

Timeline

Start

2026-03-01

Primary completion

2027-08

Completion

2027-08

Publications

• Background Bennett MI, Kaasa S, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic cancer-related pain. Pain. 2019 Jan;160(1):38-44. doi: 10.1097/j.pain.0000000000001363.
• Background van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.
• Background WHO Guidelines for the Pharmacological and Radiotherapeutic Management of Cancer Pain in Adults and Adolescents. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK537492/
• Background Bennett MI. Effectiveness of antiepileptic or antidepressant drugs when added to opioids for cancer pain: systematic review. Palliat Med. 2011 Jul;25(5):553-9. doi: 10.1177/0269216310378546. Epub 2010 Jul 29.
• Background Lee JT, Sanderson CR, Xuan W, Agar M. Lidocaine for Cancer Pain in Adults: A Systematic Review and Meta-Analysis. J Palliat Med. 2019 Mar;22(3):326-334. doi: 10.1089/jpm.2018.0257. Epub 2019 Jan 7.
• Background Mestdagh F, Steyaert A, Lavand'homme P. Cancer Pain Management: A Narrative Review of Current Concepts, Strategies, and Techniques. Curr Oncol. 2023 Jul 18;30(7):6838-6858. doi: 10.3390/curroncol30070500.
• Background Zhu B, Zhou X, Zhou Q, Wang H, Wang S, Luo K. Intra-Venous Lidocaine to Relieve Neuropathic Pain: A Systematic Review and Meta-Analysis. Front Neurol. 2019 Sep 18;10:954. doi: 10.3389/fneur.2019.00954. eCollection 2019.
• Background Orhurhu V, Orhurhu MS, Bhatia A, Cohen SP. Ketamine Infusions for Chronic Pain: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Anesth Analg. 2019 Jul;129(1):241-254. doi: 10.1213/ANE.0000000000004185.
• Background Jonkman K, van de Donk T, Dahan A. Ketamine for cancer pain: what is the evidence? Curr Opin Support Palliat Care. 2017 Jun;11(2):88-92. doi: 10.1097/SPC.0000000000000262.
• Background Kandil E, Melikman E, Adinoff B. Lidocaine Infusion: A Promising Therapeutic Approach for Chronic Pain. J Anesth Clin Res. 2017 Jan;8(1):697. doi: 10.4172/2155-6148.1000697. Epub 2017 Jan 11.
• Background Iacob E, Hagn EE, Sindt J, Brogan S, Tadler SC, Kennington KS, Hare BD, Bokat CE, Donaldson GW, Okifuji A, Junkins SR. Tertiary Care Clinical Experience with Intravenous Lidocaine Infusions for the Treatment of Chronic Pain. Pain Med. 2018 Jun 1;19(6):1245-1253. doi: 10.1093/pm/pnx167.
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• Background Mystakidou K, Mendoza T, Tsilika E, Befon S, Parpa E, Bellos G, Vlahos L, Cleeland C. Greek brief pain inventory: validation and utility in cancer pain. Oncology. 2001;60(1):35-42. doi: 10.1159/000055294.
• Background Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.
• Background Bennett M. The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs. Pain. 2001 May;92(1-2):147-57. doi: 10.1016/s0304-3959(00)00482-6.
• Background Lee J, Currow D, Lovell M, Phillips JL, McLachlan A, Ritchie M, Brown L, Fazekas B, Aggarwal R, Seah D, Sheehan C, Chye R, Noble B, McCaffrey N, Aggarwal G, George R, Kow M, Ayoub C, Linton A, Sanderson C, Mittal D, Rao A, Prael G, Urban K, Vandersman P, Agar M. Lidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study. BMJ Open. 2023 Feb 21;13(2):e066125. doi: 10.1136/bmjopen-2022-066125.
• Background Olkkola KT, Ahonen J. Midazolam and other benzodiazepines. Handb Exp Pharmacol. 2008;(182):335-60. doi: 10.1007/978-3-540-74806-9_16.
• Background Gewandter JS, Dworkin RH, Turk DC, McDermott MP, Baron R, Gastonguay MR, Gilron I, Katz NP, Mehta C, Raja SN, Senn S, Taylor C, Cowan P, Desjardins P, Dimitrova R, Dionne R, Farrar JT, Hewitt DJ, Iyengar S, Jay GW, Kalso E, Kerns RD, Leff R, Leong M, Petersen KL, Ravina BM, Rauschkolb C, Rice ASC, Rowbotham MC, Sampaio C, Sindrup SH, Stauffer JW, Steigerwald I, Stewart J, Tobias J, Treede RD, Wallace M, White RE. Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations. Pain. 2014 Sep;155(9):1683-1695. doi: 10.1016/j.pain.2014.05.025. Epub 2014 May 24.
• Background Chu R, Umukoro N, Greer T, Roberts J, Adekoya P, Odonkor CA, Hagedorn JM, Olatoye D, Urits I, Orhurhu MS, Umukoro P, Viswanath O, Hasoon J, Kaye AD, Orhurhu V. Intravenous Lidocaine Infusion for the Management of Early Postoperative Pain: A Comprehensive Review of Controlled Trials. Psychopharmacol Bull. 2020 Oct 15;50(4 Suppl 1):216-259. doi: 10.64719/pb.4391.
• Background Mathias SD, Crosby RD, Qian Y, Jiang Q, Dansey R, Chung K. Estimating minimally important differences for the worst pain rating of the Brief Pain Inventory-Short Form. J Support Oncol. 2011 Mar-Apr;9(2):72-8. doi: 10.1016/j.suponc.2010.12.004.

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