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

NCT ID: NCT05906121

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2024-08-31

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.

Conditions

Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilhelm Ruppen, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, University Hospital of Basel (USB)

Locations

Department of Anaesthesiology, University Hospital of Basel (USB)

Basel, , Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2023-00658; am23Schneider2

Identifier Type: -

Identifier Source: org_study_id