The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain.
Recruiting now · Early Phase 1 · Has a placebo group
Conditions studied: Opioid-Refractory Chronic Cancer-Related Pain
In brief
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.
Key facts
- Study ID
- NCT07408193
- Run by
- National and Kapodistrian University of Athens
- People needed
- 24
- Starts
- 2026-03-01
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School — Athens, Attica, Greece (enrolling)
Full record on ClinicalTrials.gov
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