Clinical trial

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

Name

2023-00658; am23Schneider2

Description

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.

Trial arms

Trial start

2023-05-16

Estimated PCD

2023-12-01

Trial end

2023-12-01

Status

Recruiting

Treatment

lidocaine-ketamine infusions

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)

Size

Primary endpoint

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)

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}

Updated at

2023-06-18

1 organization

1 product

1 indication

Organization

University Hospital Basel

Product

Lidocaine + Ketamine

Indication

Chronic Pain