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

ConditionOpioid-Refractory Chronic Cancer-Related Pain
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational and Kapodistrian University of Athens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Lidocaine and Ketamine Infusion

    Drug

    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.

  • Active Placebo (Midazolam) Infusion

    Drug

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Lidocaine and Ketamine InfusionActive comparator 1 intervention
Group B: Active Placebo (Midazolam) InfusionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in the Worst Pain During the Last 24 Hours on an 11-Point, 0 to 10, Numerical Rating Scale

Question 3 of the Brief Pain Inventory - Short Form, where 0 is equivalent to no pain and 10 indicates the worst possible pain.

Time frame
Baseline (immediately before the first LK or placebo infusion) and one week after the second infusion.

Secondary outcomes

1

Changes in the Score of Pain Intensity of the Brief Pain Inventory - Short Form

Assesses changes in patient-reported pain severity, including worst, least, average pain over the past 24 hours, and current pain ("pain right now").

Time frame
Baseline (before the first LK or placebo infusion), before the second infusion (LK or placebo), and, one week after the second infusion (LK or placebo).
2

Change in the Proportion of Patients Achieving 2-Point Reduction on Worst and Least Pain of the Brief Pain Inventory - Short Form

Evaluates the proportion of patients achieving a clinically significant improvement, defined as a ≥2-point reduction in worst and least pain on the Brief Pain Inventory.

Time frame
Baseline (before the first LK or placebo infusion), before the second infusion (LK or placebo), and, one week after the second infusion (LK or placebo).
3

Change in the Score of the Interference Scale of the Brief Pain Inventory - Short Form

Measures changes in the degree to which pain interferes with daily functioning, mood, sleep, work, and social activities.

Time frame
Baseline (before the first LK or placebo infusion), before the second infusion (LK or placebo), and, one week after the second infusion (LK or placebo).
4

Change in total Oral Morphine Equivalents Consumption of the Previous Week

Assesses changes in total opioid use by calculating the weekly oral morphine equivalent dose consumed by each participant.

Time frame
Baseline (before the first LK or placebo infusion), before the second infusion (LK or placebo), and, one week after the second infusion (LK or placebo).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National and Kapodistrian University of Athens

Lead sponsor

Attikon Hospital

Collaborator

Source ClinicalTrials.gov
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