Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:56 AM
Study NCT ID:
NCT07408193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072716', 'term': 'Cancer Pain'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the Worst Pain During the Last 24 Hours on an 11-Point, 0 to 10, Numerical Rating Scale', 'timeFrame': 'Baseline (immediately before the first LK or placebo infusion) and one week after the second infusion.', 'description': 'Question 3 of the Brief Pain Inventory - Short Form, where 0 is equivalent to no pain and 10 indicates the worst possible pain.'}], 'secondaryOutcomes': [{'measure': 'Changes in the Score of Pain Intensity of the Brief Pain Inventory - Short Form', 'timeFrame': 'Baseline (before the first LK or placebo infusion), before the second infusion (LK or placebo), and, one week after the second infusion (LK or placebo).', 'description': 'Assesses changes in patient-reported pain severity, including worst, least, average pain over the past 24 hours, and current pain ("pain right now").'}, {'measure': 'Change in the Proportion of Patients Achieving 2-Point Reduction on Worst and Least Pain of the Brief Pain Inventory - Short Form', 'timeFrame': 'Baseline (before the first LK or placebo infusion), before the second infusion (LK or placebo), and, one week after the second infusion (LK or placebo).', 'description': 'Evaluates the proportion of patients achieving a clinically significant improvement, defined as a ≥2-point reduction in worst and least pain on the Brief Pain Inventory.'}, {'measure': 'Change in the Score of the Interference Scale of the Brief Pain Inventory - Short Form', 'timeFrame': 'Baseline (before the first LK or placebo infusion), before the second infusion (LK or placebo), and, one week after the second infusion (LK or placebo).', 'description': 'Measures changes in the degree to which pain interferes with daily functioning, mood, sleep, work, and social activities.'}, {'measure': 'Change in total Oral Morphine Equivalents Consumption of the Previous Week', 'timeFrame': 'Baseline (before the first LK or placebo infusion), before the second infusion (LK or placebo), and, one week after the second infusion (LK or placebo).', 'description': 'Assesses changes in total opioid use by calculating the weekly oral morphine equivalent dose consumed by each participant.'}, {'measure': 'Immediate Analgesic Effect of the Infusion (LK or placebo)', 'timeFrame': 'Before the infusion and one hour after infusion termination.', 'description': 'Evaluated using question 6 of the Brief Pain Inventory - Short Form (pain right now)'}, {'measure': 'Change in the Score of the Beck Depression Inventory', 'timeFrame': 'Baseline (immediately before the first LK or placebo infusion) and one week after the second infusion.', 'description': 'Measures changes in depressive symptom severity associated with treatment over the course of the study. Beck Depression inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Scores range from 0 to 63, where higher score indicates more depressive symptoms.'}, {'measure': 'Rating of Overall Improvement Using Patient Global Impression of Change Scale', 'timeFrame': 'one week after the second (LK or placebo) infusion', 'description': 'Assesses the patient\'s overall perceived improvement in pain and function following the treatment. PGIC is a 7 point scale depicting a patient\'s rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Pain', 'Treatment-Resistant Chronic Pain', 'Lidocaine', 'Ketamine', 'Analgesics, Adjuvant', 'Infusions, Intravenous', 'Cross-Over Studies', 'Double-Blind Method', 'Patient Reported Outcome Measures', 'Opioid-Related Disorders', 'Neoplasms'], 'conditions': ['Opioid-Refractory Chronic Cancer-Related Pain']}, 'referencesModule': {'references': [{'pmid': '30586069', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17355955', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30776210', 'type': 'BACKGROUND', 'citation': '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/'}, {'pmid': '20671006', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30614748', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37504360', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '31620064', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31082965', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28306568', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28239510', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29016948', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29870458', 'type': 'BACKGROUND', 'citation': 'Cohen SP, Bhatia A, Buvanendran A, Schwenk ES, Wasan AD, Hurley RW, Viscusi ER, Narouze S, Davis FN, Ritchie EC, Lubenow TR, Hooten WM. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):521-546. doi: 10.1097/AAP.0000000000000808.'}, {'pmid': '37850330', 'type': 'BACKGROUND', 'citation': 'Striebel J, Ruppen W, Schneider T. Simultaneous application of lidocaine and ketamine during ambulatory infusion therapy: a retrospective analysis. Pain Manag. 2023 Sep;13(9):539-553. doi: 10.2217/pmt-2023-0037. Epub 2023 Oct 18.'}, {'pmid': '12642389', 'type': 'BACKGROUND', 'citation': 'Sugimoto M, Uchida I, Mashimo T. Local anaesthetics have different mechanisms and sites of action at the recombinant N-methyl-D-aspartate (NMDA) receptors. Br J Pharmacol. 2003 Mar;138(5):876-82. doi: 10.1038/sj.bjp.0705107.'}, {'pmid': '8080219', 'type': 'BACKGROUND', 'citation': 'Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.'}, {'pmid': '18055266', 'type': 'BACKGROUND', '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. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.'}, {'pmid': '11150906', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15030944', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11323136', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36810169', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18175099', 'type': 'BACKGROUND', 'citation': 'Olkkola KT, Ahonen J. Midazolam and other benzodiazepines. Handb Exp Pharmacol. 2008;(182):335-60. doi: 10.1007/978-3-540-74806-9_16.'}, {'pmid': '24865794', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33633427', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21542414', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.iasp-pain.org/publications/pain/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Background\n\nOpioids are the mainstay of treatment for chronic cancer-related pain, but their use is associated with multiple adverse effects, tolerance requiring progressively higher doses, and, in rare cases, opioid-induced hyperalgesia. Standard adjuvant analgesics (antiepileptics and antidepressants) may provide modest benefit. However, despite maximally tolerated therapy, many patients continue to experience refractory pain.\n\nLidocaine and low-dose ketamine may be beneficial in these difficult-to-treat pain scenarios due to their favorable safety profile and mechanisms of action. The main limitation of these drugs is their short duration of action; however, mechanisms involving central plasticity and reversal of opioid tolerance and opioid-induced hyperalgesia may explain the longer analgesic effects observed in some studies.\n\nStudy Design\n\nThis is a randomized, double-blind, active placebo-controlled, cross-over trial evaluating the efficacy of two weekly lidocaine-ketamine (LK) infusions compared to active placebo in patients with opioid-refractory chronic cancer-related pain.\n\nThe investigators will assess:\n\nPain intensity and physical functioning using the Brief Pain Inventory (BPI) Emotional functioning using the Beck Depression Inventory (BDI) Patient-reported overall improvement using the Patient Global Impression of Change (PGIC) scale Total opioid consumption expressed as oral morphine equivalents (MME) Neuropathic pain effects in patients with confirmed neuropathic components using the Neuropathic Pain Symptom Inventory (NPSI)\n\nAdult patients presenting to the pain clinic of Attikon University General Hospital with a diagnosis of chronic cancer-related pain according to the International Association for the Study of Pain definition will be screened for eligibility. Participants will be adult patients with chronic cancer-related pain who continue to experience moderate to severe pain despite stable, optimized analgesic therapy. Eligible patients will be on a stable opioid regimen of at least 60 mg oral morphine equivalents per day for at least one week, with stable adjuvant analgesics in those with a neuropathic pain component. A minimum life expectancy of three months and the ability to provide informed consent will be required. Patients with significant hepatic or renal dysfunction, uncontrolled psychiatric or neurological illness, pregnancy, or contraindications to lidocaine, ketamine, or midazolam will be excluded. The presence of a neuropathic pain component will be assessed clinically and with validated instruments to allow exploratory subgroup analyses of treatment effects on neuropathic pain.\n\nRandomization and Blinding Patients will be randomized using a computer-generated sequence in blocks of four.\n\nAllocation will be concealed in sequentially numbered sealed envelopes. Infusions will be prepared by anesthesiology staff not involved in the trial, using identical, unmarked transparent syringes to maintain blinding.\n\nBoth patients and assessors (including companions or clinic staff assisting with questionnaires) will be blinded to treatment.\n\nIntervention\n\nActive intervention (LK infusion):\n\nLidocaine 4 mg/kg + ketamine 0.2 mg/kg, administered over 45 minutes using an electronic infusion pump Dosing based on actual body weight; for BMI \\>30, ideal body weight will be used\n\nActive placebo: Midazolam 0.02 mg/kg IV over 45 minutes, selected to mimic sedative effects without analgesic activity\n\nProcedure:\n\nPre-infusion: patients complete questionnaires and undergo brief clinical assessment IV cannula insertion and standard monitoring (pulse oximeter, ECG, non-invasive BP) Infusion over 45 minutes, followed by 1-hour post-infusion observation Two infusions will be administered 7 days apart After a 14-day washout, patients cross over to the alternate intervention\n\nRescue Analgesia\n\nAll patients will have access to rescue analgesics (e.g., oral oxycodone), converted to oral morphine equivalents for measurement and comparison.\n\nSafety Monitoring Hepatic function: SGOT/SGPT monitored during the study Renal function: Creatinine and GFR monitored\n\nProtocol adjustments:\n\nIf SGOT/SGPT above ULN =\\> Extend infusion to 60 min; If SGOT/SGPT \\>3x ULN =\\> Reduce lidocaine dose to 2 mg/kg; If. SGOT/SGPT \\>5x ULN, Child B/C liver disease, or GFR \\<30ml/min =\\> Discontinue participation\n\nCommon side effects:\n\nLidocaine: lightheadedness, somnolence, peri-oral paresthesia, nausea, headache, dysarthria, dry mouth, metallic taste Ketamine: nausea, vomiting, psychotomimetic effects, headache, fatigue, sedation\n\nOutcome Measures\n\nPrimary Outcome:\n\nChange in BPI question 3 (pain intensity) from baseline to end of treatment.\n\nSecondary Outcomes:\n\nPhysical functioning (BPI) Emotional functioning (BDI) Patient Global Impression of Change (PGIC) Opioid consumption (MME) Neuropathic pain (NPSI)\n\nStatistical analysis will be performed using the SPSS software package (IBM SPSS Statistics, Chicago, IL, USA) and R Project. The Shapiro-Wilk test will be applied to assess the normality of data distribution, and the level of statistical significance will be set at 5% (p \\< 0.05). Continuous variables with a normal distribution will be expressed as mean ± standard deviation (mean ± SD), whereas those not following the normal distribution will be presented as median and interquartile range (IQR). Categorical variables will be presented as absolute and relative frequencies (percentages).\n\nComparisons between the two treatment conditions in the crossover design will be performed using the paired Student's t-test or the Wilcoxon signed-ranks test, depending on the normality of the data distribution. To explore potential correlations among study parameters, Pearson's correlation coefficient (r) or other appropriate correlation coefficients will be calculated. If required by the study findings, additional analyses-such as multivariable logistic regression to identify independent determinants of observed changes, or mixed-effects model analyses-will be conducted.\n\nSample size calculation was performed using the Hedwig tool provided online by Massachusetts General Hospital Biostatistics Center. A sample of 20 patients has 80% statistical power for a level of significance of a=0.05 to detect a clinically significant change of 2 points in question 3 of the Brief Pain Inventory - Short Form from baseline to end of treatment assessment, given an SD of 3 based on data from studies assessing this particular outcome. Based on that, at least 20 patients need to be enrolled. We aim to enroll 24 patients.\n\nCommon side effects associated with lidocaine infusion include lightheadedness, somnolence, peri-oral paresthesia, nausea, headache, dysarthria, dry mouth, metallic taste. Common side effects associated with ketamine infusion include nausea, vomiting, psychotomimetic effects, headache, fatigue, sedation. No serious adverse events have been reported with these drugs at the dosages used in this RCT. Any adverse events will be reported, along with any action taken."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or more\n* Capacity to provide informed consent, ability to complete study assessments and comply with the study procedures\n* Meets the IASP definition for chronic cancer-related pain\n* Moderate or severe pain, defined as average pain of 4 or greater on an 11-point (0-10) NRS in the past 24h\n* Adequate trial of opioid medication, defined as a dose of at least 60 mg/day oral morphine equivalent or maximum tolerated dose, in the past 24h\n* For patients with neuropathic component to pain: adequate trial of at least one adjuvant analgesic, defined as a daily dose of at least Amitriptyline 37.5mg, Duloxetine 30mg, Gabapentin 900mg, Pregabalin 150mg, Venlafaxine 60mg or equivalent (26), or maximum tolerated dose in the past 24h\n\nExclusion Criteria:\n\n* Previous adverse reaction to ketamine, lidocaine or other amide-type local anesthetics, midazolam\n* Severe liver disease (Child Class B or C)\n* SGPT or SGOT \\>5 times the upper limit of normal\n* End stage kidney disease\n* Serious cardiac comorbidity (e.g. unstable angina, poorly controlled hypertension or tachycardia, high-risk coronary vascular disease, symptomatic heart failure with NYHA class III-IV, history of heart block, Wolf-Parkinson-White syndrome, Adams-Stokes syndrome)\n* Elevated intracranial or intraocular pressure\n* Pheochromocytoma or poorly controlled hyperthyroidism\n* History of psychosis, schizophrenia or substance abuse\n* Pregnant or breastfeeding\n* Porphyria\n* Life expectancy shorter than the duration of the study'}, 'identificationModule': {'nctId': 'NCT07408193', 'briefTitle': 'The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain.', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain: a Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Trial.', 'orgStudyIdInfo': {'id': '801/30-12-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine and Ketamine Infusion', 'interventionNames': ['Drug: Lidocaine and Ketamine Infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Active Placebo (Midazolam) Infusion', 'interventionNames': ['Drug: Active Placebo (Midazolam) Infusion']}], 'interventions': [{'name': 'Lidocaine and Ketamine Infusion', 'type': 'DRUG', 'description': 'Participants receive two intravenous infusions, 7 days apart, containing lidocaine 4 mg/kg and ketamine 0.2 mg/kg (using actual body weight, or ideal body weight if BMI \\>30). The drugs are combined in a single, clear solution and administered via an electronic pump in an outpatient setting.', 'armGroupLabels': ['Lidocaine and Ketamine Infusion']}, {'name': 'Active Placebo (Midazolam) Infusion', 'type': 'DRUG', 'description': 'Participants receive two intravenous infusions, 7 days apart, containing midazolam 0.02mg/kg (using actual body weight, or ideal body weight if BMI \\>30). The drugs are combined in a single, clear solution and administered via an electronic pump in an outpatient setting.', 'armGroupLabels': ['Active Placebo (Midazolam) Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12461', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'contacts': [{'name': 'Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology', 'role': 'CONTACT', 'email': 'kkalimeris@med.uoa.gr', 'phone': '+302105831997'}, {'name': 'Erond Zeneli, MD', 'role': 'CONTACT', 'phone': '+306982094129'}, {'name': 'Erond Zeneli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor', 'role': 'CONTACT', 'email': 'kkalimeris@med.uoa.gr', 'phone': '+302105831997'}, {'name': 'Erond Zeneli MD, PhD candidate', 'role': 'CONTACT', 'email': 'erond.zeneli@gmail.com', 'phone': '+306982094129'}], 'overallOfficials': [{'name': 'Konstantinos Kalimeris, Assoc Prof of Anesthesiology', 'role': 'STUDY_CHAIR', 'affiliation': 'National and Kapodistrian University of Athens'}, {'name': 'Maria Riga, Assis Prof of Anesthesiology', 'role': 'STUDY_CHAIR', 'affiliation': 'National and Kapodistrian University of Athens'}, {'name': 'Ioannis Kotsantis, Assis Prof of Oncology', 'role': 'STUDY_CHAIR', 'affiliation': 'National and Kapodistrian University of Athens'}]}, 'ipdSharingStatementModule': {'url': 'https://attikonhospital.gov.gr/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'They will be available from the end of the recording of the response of the last patient and for 5 years thereafter.', 'ipdSharing': 'YES', 'accessCriteria': 'Researchers that would have come in contact with our team firstly and that shall be able to prove that they will use the data solely for research purposes and not for commercial use.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Attikon Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology', 'investigatorFullName': 'Konstantinos Kalimeris', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}