Clinical trial · Interventional
The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain.
The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain: a Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Trial.
NCT07408193CI-TRIAL-00117116recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid-Refractory Chronic Cancer-Related Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Placebo (Midazolam) Infusion | Drug | — | UNRESOLVED |
| Lidocaine and Ketamine Infusion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or more * Capacity to provide informed consent, ability to complete study assessments and comply with the study procedures * Meets the IASP definition for chronic cancer-related pain * Moderate or severe pain, defined as average pain of 4 or greater on an 11-point (0-10) NRS in the past 24h * 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 * 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 Exclusion Criteria: * Previous adverse reaction to ketamine, lidocaine or other amide-type local anesthetics, midazolam * Severe liver disease (Child Class B or C) * SGPT or SGOT \>5 times the upper limit of normal * End stage kidney disease * 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) * Elevated intracranial or intraocular pressure * Pheochromocytoma or poorly controlled hyperthyroidism * History of psychosis, schizophrenia or substance abuse * Pregnant or breastfeeding * Porphyria * Life expectancy shorter than the duration of the study
References
Publications (24)
- BACKGROUNDBennett 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 30586069
- BACKGROUNDvan 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 17355955
- BACKGROUNDWHO 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 30776210
- BACKGROUNDBennett 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 20671006
- BACKGROUNDLee 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 30614748
- BACKGROUNDMestdagh 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 37504360
- BACKGROUNDZhu 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 31620064