Lidocaine and Ketamine Levels in Plasma After Simultaneous Lidocaine/Ketamine Infusions

Lidocaine and Ketamine Levels in Plasma After Simultaneous Lidocaine/Ketamine Infusions. An Observational Assessment of Therapy Effects and Side-effects.

The aim of this monocentric observational pilot study is to measure the lidocaine plasma level in a limited number of patients to generate explorative data on inter- and intrapersonal stability and safety of drug plasma levels and to investigate whether higher plasma levels of ketamine can be correlated with a better analgesic effect.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: lidocaine-ketamine infusions

Detailed Description

There are different treatment strategies for chronic pain. One possible treatment strategy, especially for therapy-resistant pain, is intravenous infusions with certain pharmacological agents, such as lidocaine and ketamine. This study is to measure the concentration of lidocaine in the plasma of patients at the University Hospital of Basel (USB) after an intravenous infusion with 4mg/kg lidocaine over 30 minutes in order to generate explorative data on inter- and intrapersonal stability and safety of drug plasma levels. The prospective side effects of lidocaine and ketamine is assessed and the plasma levels are correlated with the analgesic efficacy and change in possible depressive symptoms.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Anaesthesiology, University Hospital of Basel (USB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

15 patients (10 + Drop-out of 50%) newly receiving lidocaine-ketamine infusions at the USB will be randomly selected.

Description

Inclusion Criteria:

• Patient is a new recipient of lidocaine-ketamine infusions
• Patient is able to provide Informed Consent

Exclusion Criteria:

• Contraindication to blood sampling (on arm not used for infusion)
• Insufficient knowledge of German language
• Inability to give consent
• Patient is under 18 years of age
• Contraindication to treatment with lidocaine and/or ketamine

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lidocaine plasma level	Concentration of lidocaine in the plasma of patients who received an intravenous infusion with 4mg/kg lidocaine and 0.15 - 0.5mg/kg ketamine over 30 minutes at the time directly after the infusion.	After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ketamine plasma level	Concentration of ketamine in the plasma of patients who received an intravenous infusion with 4mg/kg lidocaine and 0.15 - 0.5mg/kg ketamine over 30 minutes at the time directly after the infusion.	After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
Change in pain assessment	Change of pain assessed by the Short form - McGill Pain Questionnaire (SF- MPQ). he main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.	After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
Change in mood assessment	Change of mood assessed by the Beck Depression Questionnaire II (BDI-II); Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression	After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Wilhelm Ruppen, Prof., Department of Anaesthesiology, University Hospital of Basel (USB)

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Ketamine; Lidocaine; lidocaine/ketamine infusions; Short form - McGill Pain Questionnaire (SF - MPQ); Beck Depression Questionnaire (BDI-II)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Neurotransmitter Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Anesthetics, Intravenous; Anesthetics, General; Excitatory Amino Acid Agents; Anesthetics, Dissociative; Excitatory Amino Acid Antagonists; Lidocaine; Ketamine
• Other Study ID Numbers: 2023-00658; am23Schneider2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No