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

NCT07408193 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-07

No results posted yet for this study

Summary

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

  • Opioid-Refractory Chronic Cancer-Related Pain

Interventions

DRUG

Lidocaine and Ketamine Infusion

Participants receive two intravenous infusions, 7 days apart, containing lidocaine 4 mg/kg and ketamine 0.2 mg/kg (using actual body weight, or ideal body weight if BMI \>30). The drugs are combined in a single, clear solution and administered via an electronic pump in an outpatient setting.

DRUG

Active Placebo (Midazolam) Infusion

Participants receive two intravenous infusions, 7 days apart, containing midazolam 0.02mg/kg (using actual body weight, or ideal body weight if BMI \>30). The drugs are combined in a single, clear solution and administered via an electronic pump in an outpatient setting.

Sponsors & Collaborators

  • Attikon Hospital

    collaborator OTHER

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Konstantinos Kalimeris, Assoc Prof of Anesthesiology · National and Kapodistrian University of Athens

  • Maria Riga, Assis Prof of Anesthesiology · National and Kapodistrian University of Athens

  • Ioannis Kotsantis, Assis Prof of Oncology · National and Kapodistrian University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07408193 on ClinicalTrials.gov