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NCT Number: NCT05906121

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology, University Hospital of Basel (USB)

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lidocaine-ketamine infusions

Drug

Lidocaine and ketamine are infused over a period of 30 minutes. The dosage of lidocaine is 4mg/kg is maintained throughout the infusions, and the dosage of ketamine is increased within the first three infusions from 0.15mg/kg at the first, to 0.25mg/kg at the second and 0.5mg/kg at the third infusion. In case patients already experiencing sufficient analgesic effect and/or improvement in quality of life after the 1st or 2nd infusion or if side effects do not allow a further dose increase, no further step up of ketamine dosage is made. As a part of this study, at the end of the first, second and third infusion, side effects will be screened using customized questionnaires (SF - MPQ, BDI-II)

Primary outcomes

  1. Change in Lidocaine plasma level

    Time frame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)

    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.

Secondary outcomes

  1. Change in Ketamine plasma level

    Time frame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)

    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.

  2. Change in pain assessment

    Time frame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)

    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.

  3. Change in mood assessment

    Time frame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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