This Early Phase I, randomised, double-blinded, placebo-controlled, cross-over trial (n=24) will evaluate the efficacy of intravenous infusions of lidocaine and ketamine in patients suffering from opioid-refractory chronic cancer-related pain. Participants will receive two infusions, spaced one week apart, consisting of lidocaine at 4 mg/kg and ketamine at 0.2 mg/kg, compared to an active placebo of midazolam at 0.02 mg/kg. The primary aim is to determine whether the lidocaine-ketamine regimen provides superior analgesia compared to the placebo. The trial will assess various outcomes, including pain intensity and physical functioning using the Brief Pain Inventory (BPI), emotional functioning via the Beck Depression Inventory (BDI), and overall improvement through the Patient Global Impression of Change (PGIC) scale. Additionally, total opioid consumption will be measured in oral morphine equivalents, and neuropathic pain effects will be evaluated using the Neuropathic Pain Symptom Inventory (NPSI). Eligible participants are adults aged 18 years or older with moderate to severe cancer-related pain despite optimised analgesic therapy. The study is set to begin in March 2026 and is expected to conclude by August 2027.
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.