Clinical trial NCT05906121: Lidocaine and Ketamine Levels in Plasma After Simultaneous Lidocaine/Ketamine Infusions
Official title: Lidocaine and Ketamine Levels in Plasma After Simultaneous Lidocaine/Ketamine Infusions. An Observational Assessment of Therapy Effects and Side-effects.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Lidocaine
Ketamine
lidocaine/ketamine infusions
Short form - McGill Pain Questionnaire (SF - MPQ)
Beck Depression Questionnaire (BDI-II)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Lidocaine plasma level
timeFrame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
Secondary outcomes:
measure: Change in Ketamine plasma level
timeFrame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
measure: Change in pain assessment
timeFrame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
measure: Change in mood assessment
timeFrame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Anaesthesiology, University Hospital of Basel (USB)
Study officials:
affiliation: Department of Anaesthesiology, University Hospital of Basel (USB)
name: Wilhelm Ruppen, Prof.
role: PRINCIPAL_INVESTIGATOR
References: