Clinical TrialChronic PainKetaminePlaceboNot yet recruiting

The Role of Coadministration of Lidocaine and Ketamine in Opioid-Refractory Chronic Cancer-Related Pain.

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.

Target Enrollment
24 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

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.

Study Arms & Interventions

Lidocaine and Ketamine Infusion

active comparator

Interventions

  • Ketamine4 mg/kg
    via IV• twice• 2 doses total

Active Placebo (Midazolam) Infusion

inactive

Interventions

  • Placebo0.02 mg/kg
    via IV• twice• 2 doses total

Participants

Ages
18 – ?
Sexes
All

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

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2026-03-01
    End: 2027-08-01
  • Compounds
    KetaminePlacebo
  • Topic
    Chronic Pain

Study Team

Sponsors & Collaborators

Locations

University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School — Athens, Attica, Greece

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