Lidocaine and Ketamine for opioid-refractory cancer pain
Official title: The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain: a Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Trial.
Run by National and Kapodistrian University of Athens · NCT07408193 · Data updated 2026-11-12
This randomized, double-blind, cross-over study tests whether two weekly infusions of lidocaine and low-dose ketamine reduce pain more than an active placebo in adults with cancer-related pain not controlled by opioids.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 1 site (Athens, Attica) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07408193 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with moderate to severe opioid-refractory chronic cancer-related pain who have had an adequate opioid trial and, if neuropathic, an adequate adjuvant analgesic trial.
✕Probably not a fit
Patients without pain relief or with intolerable adverse effects may not benefit from this regimen.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase, cross-over trial compares two weekly intravenous infusions of lidocaine (4 mg/kg) and ketamine (0.2 mg/kg) against an active placebo (midazolam) in patients with moderate to severe opioid-refractory chronic cancer-related pain. Participants receive both treatments in a randomized sequence, with outcomes including pain intensity, physical and emotional function, patient-reported global improvement, and opioid consumption. The study aims to determine if the LK regimen provides superior analgesia and functional benefits compared with active placebo. Safety monitoring focuses on known risks of lidocaine and ketamine in this patient population. Eligible adults must have chronic cancer pain, adequate opioid exposure, and, if neuropathic, prior adjuvant analgesic use.
Why it matters
Potential benefit: If successful, the LK regimen could offer a new option to reduce pain and opioid needs in patients with treatment-refractory cancer pain.
How similar studies have gone: Previous small studies suggest potential analgesic effects of lidocaine and ketamine in refractory pain, but results are not yet definitive in this specific cancer-pain population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School
Athens, Attica, Greece Recruiting
Study contacts
- Study coordinator: Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor
- Email: kkalimeris@med.uoa.gr
- Phone: +302105831997
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.