Chronic PainNCT05906121
Lidocaine and Ketamine Levels in Plasma After Simultaneous Lidocaine/Ketamine Infusions
An observational study of Chronic Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- lidocaine-ketamine infusions
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 May 2023to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 15 patients (10 + Drop-out of 50%) newly receiving lidocaine-ketamine infusions at the USB will be randomly selected.
Who may be able to join
- Patient is a new recipient of lidocaine-ketamine infusions
- Patient is able to provide Informed Consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesiology, University Hospital of Basel (USB)
Basel, 4031
About this study
Official title: Lidocaine and Ketamine Levels in Plasma After Simultaneous Lidocaine/Ketamine Infusions. An Observational Assessment of Therapy Effects and Side-effects.
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.
Read the 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
- Being tested
- lidocaine-ketamine infusions
- Keywords
- Lidocaine, Ketamine, lidocaine/ketamine infusions, Short form - McGill Pain Questionnaire (SF - MPQ), Beck Depression Questionnaire (BDI-II)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine-ketamine infusionsDrug
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
Change in pain assessment
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.
Measured: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
Change in mood assessment
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
Measured: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start16 May 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilhelm Ruppen, Prof., Principal investigator, Department of Anaesthesiology, University Hospital of Basel (USB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906121
- Sponsor's protocol ID
- 2023-00658; am23Schneider2
- Other IDs
- 2023
- Status last verified
- May 2025
- First submitted
- 6 Jun 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine and Ketamine Levels in Plasma After Simultaneous Lidocaine/Ketamine Infusions. An Observational Assessment of Therapy Effects and Side-effects.
- ClinicalTrials.gov ID
- NCT05906121
- Acronym / sponsor ID
- 2023-00658; am23Schneider2
- Conditions
- Chronic Pain
- Keywords
- Lidocaine, Ketamine, lidocaine/ketamine infusions, Short form - McGill Pain Questionnaire (SF - MPQ), Beck Depression Questionnaire (BDI-II)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 15 patients (10 + Drop-out of 50%) newly receiving lidocaine-ketamine infusions at the USB will be randomly selected.
Key inclusion criteria (2 listed)
- Patient is a new recipient of lidocaine-ketamine infusions
- Patient is able to provide Informed Consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine-ketamine infusionsLidocaine 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) | Drug | – |
Primary outcome
Change in Lidocaine plasma level
Time frame: 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.
3 secondary outcomes
Change in Ketamine plasma level
Time frame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
Change in pain assessment
Time frame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
Change in mood assessment
Time frame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilhelm Ruppen, Prof. principal investigator
Department of Anaesthesiology, University Hospital of Basel (USB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lidocaine plasma level (time frame: After infusion 1 (Baseline), after infusion 2 (28 days after infusion 1), after infusion 3 (28 days after infusion 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.