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

NCT05906121 | Completed

• 1 other identifier: 2023-00658; am23Schneider2
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Lidocaine; Ketamine; lidocaine/ketamine infusions; Short form - McGill Pain Questionnaire (SF - MPQ); Beck Depression Questionnaire (BDI-II)

Outcome Measures

Primary Outcomes (1)

• Change in Lidocaine plasma level

  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.

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

Secondary Outcomes (3)

• 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)

• 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 in mood assessment

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

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient is a new recipient of lidocaine-ketamine infusions
• Patient is able to provide Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Anaesthesiology, University Hospital of Basel (USB)

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Wilhelm Ruppen, Prof.

  Department of Anaesthesiology, University Hospital of Basel (USB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: May 16, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CH (1)