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NOT YET RECRUITING
NCT07408193
EARLY_PHASE1

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

Sponsor: National and Kapodistrian University of Athens

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-03

Completion Date

2027-08

Last Updated

2026-02-20

Healthy Volunteers

No

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.

Locations (1)

University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School

Athens, Attica, Greece