Chronic Neuropathic Pain and Fibromyalgia Clinical Trial
Official title:
Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain: an Observational Prospective Study
Verified date | November 2017 |
Source | Allevio Pain Management Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
As lidocaine and ketamine provide analgesia by acting on different molecular pathways, administering them together may produce synergistic effects, which can allow for using a lower dose of each medication and thereby reducing the corresponding side effects. To the investigator's knowledge, despite the common practice of multimodal analgesia, lidocaine-ketamine infusions have never been studied prospectively in an out of hospital setting to treat neuropathic pain. The aim of the present study is to evaluate the effectiveness of the current routine practice of lidocaine-ketamine infusions conducted at Allevio Pain Management Clinic, a large outpatient community based chronic pain management facility. Lidocaine-ketamine infusions are prescribed to patients that have pain that is considered to be neuropathic for which standard anti-neuropathic medications have been ineffective or poorly tolerated by patients. A prospective longitudinal study.
Status | Completed |
Enrollment | 162 |
Est. completion date | November 11, 2020 |
Est. primary completion date | November 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: Pain duration > 3 months; Multifocal and/or non-dermatomal neuropathic pain per Pain Diagram; Failed medical management with at least 2 neuromodulation agents (e.g., gabapentinoids, antidepressants, cannabinoids); Neuropathic component (12 or more points on S-LANSS); Exclusion Criteria: Non-English speakers; Refusal to sign informed consent; Allergy to ketamine and/or lidocaine; Known relative contraindications to ketamine use which include poorly controlled systemic illnesses: hypertension, hyperthyroidism, ischemic heart disease, heart failure, psychiatric comorbidity (e.g., psychosis, schizophrenia, dissociative state); Known contraindication to lidocaine use which include current symptomatic or clinically significant brady- or tachyarrhythmia, systolic blood pressure <90 or >180 mmHg; Scheduled interventions targeting neuropathic pain: epidural injections, peripheral nerve blocks, Bier block, radiofrequency of dorsal root ganglia and peripheral nerves, additional lidocaine or ketamine infusions; Newly added analgesic or neuromodulating medications within 30 days; Recently performed neuromodulating interventions within 90 days; Previous lidocaine-ketamine, lidocaine or ketamine infusion within 6 months; Acute intoxication or active illegal substance abuse; |
Country | Name | City | State |
---|---|---|---|
Canada | Allevio Pain Management Clinic | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Allevio Pain Management Clinic |
Canada,
Ballantyne JC, Mao J. Opioid therapy for chronic pain. N Engl J Med. 2003 Nov 13;349(20):1943-53. Review. — View Citation
BONICA JJ. The management of pain of cancer. J Mich State Med Soc. 1953 Mar;52(3):284-90. — View Citation
Campbell, J. N., & Meyer, R. A. (2006). Mechanisms of neuropathic pain. Neuron, 52(1), 77-92. doi:10.1016/j.neuron.2006.09.021 CDC. (2017a). Opioid Overdose. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/drugoverdose/index
Cho SK, Heiby EM, McCracken LM, Moon DE, Lee JH. Daily functioning in chronic pain: study of structural relations with posttraumatic stress disorder symptoms, pain intensity, and pain avoidance. Korean J Pain. 2011 Mar;24(1):13-21. doi: 10.3344/kjp.2011.2 — View Citation
Dale R, Stacey B. Multimodal Treatment of Chronic Pain. Med Clin North Am. 2016 Jan;100(1):55-64. doi: 10.1016/j.mcna.2015.08.012. Epub 2015 Oct 17. Review. — View Citation
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. Epub 2007 Dec 11. — View Citation
Fitzcharles MA, Baerwald C, Ablin J, Häuser W. Efficacy, tolerability and safety of cannabinoids in chronic pain associated with rheumatic diseases (fibromyalgia syndrome, back pain, osteoarthritis, rheumatoid arthritis): A systematic review of randomized — View Citation
Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16. — View Citation
Gilron I, Watson CP, Cahill CM, Moulin DE. Neuropathic pain: a practical guide for the clinician. CMAJ. 2006 Aug 1;175(3):265-75. Review. — View Citation
Goldberg DS, McGee SJ. Pain as a global public health priority. BMC Public Health. 2011 Oct 6;11:770. doi: 10.1186/1471-2458-11-770. — View Citation
IASP. (1994). Part III: Pain Terms, A Current List with Definitions and Notes on Usage. In Classification of Chronic Pain (second ed., pp. 209-214): IASP Press. Retrieved from
IASP. (2003). How Prevalent Is Chronic Pain? International Association for the Study of Pain. Retrieved from https://www.iasp-pain.org/files/Content/ContentFolders/Publications2/PainClinicalUpdates/Archives/PCU03-2_1390265045864_38.pdf
Niesters M, Martini C, Dahan A. Ketamine for chronic pain: risks and benefits. Br J Clin Pharmacol. 2014 Feb;77(2):357-67. doi: 10.1111/bcp.12094. Review. — View Citation
Noble M, Treadwell JR, Tregear SJ, Coates VH, Wiffen PJ, Akafomo C, Schoelles KM. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD006605. doi: 10.1002/14651858.CD006605.pub2. Review. — View Citation
Rogers M, Tang L, Madge DJ, Stevens EB. The role of sodium channels in neuropathic pain. Semin Cell Dev Biol. 2006 Oct;17(5):571-81. Epub 2006 Oct 28. Review. — View Citation
van Hecke O, Austin SK, Khan RA, Smith BH, Torrance N. Neuropathic pain in the general population: a systematic review of epidemiological studies. Pain. 2014 Apr;155(4):654-62. doi: 10.1016/j.pain.2013.11.013. Epub 2013 Nov 26. Review. Erratum in: Pain. 2 — View Citation
Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo — View Citation
Wahl AK, Rustøen T, Rokne B, Lerdal A, Knudsen Ø, Miaskowski C, Moum T. The complexity of the relationship between chronic pain and quality of life: a study of the general Norwegian population. Qual Life Res. 2009 Oct;18(8):971-80. doi: 10.1007/s11136-009 — View Citation
Zhou HY, Chen SR, Pan HL. Targeting N-methyl-D-aspartate receptors for treatment of neuropathic pain. Expert Rev Clin Pharmacol. 2011 May;4(3):379-88. Review. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of effectiveness of lidocaine-ketamine infusions: PQAS-R | Primary outcome measure: relative change on the PQAS-R. Moderate clinically important improvement is considered as 30% reduction (Dworkin et al., 2008) | 4 weeks after the first infusion and every 4 weeks up to 36 weeks | |
Secondary | Effect of lidocaine and ketamine infusion on BDI | Effect of lidocaine and ketamine infusion on Beck's Depression Inventory | Baseline to end-of-study every 4 weeks up to 36 weeks | |
Secondary | Effect of lidocaine and ketamine infusion on PGIC | Effect of lidocaine and ketamine infusion on Pain Global Improvement and Satisfaction | Baseline to end-of-study every 4 weeks up to 36 weeks | |
Secondary | Effect of lidocaine and ketamine infusion on BPI | Effect of lidocaine and ketamine infusion on Brief Pain Inventory | Baseline to end-of-study every 4 weeks up to 36 weeks | |
Secondary | Effect of lidocaine and ketamine infusion on PQAS-R | Effect of lidocaine and ketamine infusion on Revised Pain Quality Assessment Scale | Baseline to end-of-study every 4 weeks up to 36 weeks | |
Secondary | Effect of lidocaine and ketamine infusion on PSEQ | Effect of lidocaine and ketamine infusion on Patient Self-Efficacy Questionnaire | Baseline to end-of-study every 4 weeks up to 36 weeks | |
Secondary | Effect of lidocaine and ketamine infusion on PCS | Effect of lidocaine and ketamine infusion on Pain Catastrophizing Scale | Baseline to end-of-study every 4 weeks up to 36 weeks | |
Secondary | Effect of lidocaine and ketamine infusion on PSPDE | Effect of lidocaine and ketamine infusion on viii. Patient self-reported perceived duration of effect | Baseline to end-of-study every 4 weeks up to 36 weeks | |
Secondary | Effect of lidocaine and ketamine on narcotic consumption | Effect of lidocaine and ketamine infusion on narcotic consumption | Baseline to end-of-study up to 36 weeks |