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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT05906121

Collaborator

(none)

Enrollment

Location

6.5

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	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 Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 16, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Change in Lidocaine plasma level [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 Outcome Measures

Change in Ketamine plasma level [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.
Change in pain assessment [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.
Change in mood assessment [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