Chronic PainNCT05103319
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
An observational study of Chronic Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to retrospective investigate the effects of the simultaneous intravenous (i.v.) administration of lidocaine and ketamine on a four to six weeks interval in treatment refractory different chronic pain conditions. 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?
- Data collection for statistical analysis to identify patterns of treatment response/ non-response
- Type of treatment
- Injection or infusion
- How many people
- 319 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Sep 2021to 30 Jan 2022
- 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: The study only includes patients treated with lidocaine-ketamine infusions at the pain unit in the University Hospital of Basel (2012 -until May 2021) All data are extracted from the paper or electronic patient chart of the Pain Management-Unit of the University Hospital Basel. All data are collected retrospectively.
Who may be able to join
- ICD11 Medical diagnosis of chronic pain and its subcategories
- Treatment with intravenous lidocaine and ketamine infusions during the years of 2012 to May 2021 at our pain unit at the USB
- Patient is at least 18 years of age at the beginning of the first infusion treatment
Who cannot join
- Patient is underage at the beginning of the first infusion treatment
- Documented written refusal of consent for research (general consent or specific study consent)
- Patients undergoing treatment with only lidocaine or ketamine respective
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anesthesiology, University of Basel (USB)
Basel, 4031
About this study
Official title: Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions - A Retrospective Analysis
This study is to retrospective investigate the effects of the simultaneous intravenous (i.v.) administration of lidocaine and ketamine on a four to six weeks interval in treatment refractory different chronic pain conditions.
Read the detailed description
The use of intravenous infusion therapy with lidocaine or ketamine has been of interest in several chronic pain conditions. Studies showed a benefit in immediate pain reduction and even longer lasting pain relief for treatment approaches with lidocaine and ketamine.
While there is a broad database on the use of lidocaine and ketamine in chronic pain management as separate agents, very few pre-clinical animal studies have investigated the combined use of said analgesics and none of them reports their combined use in chronic pain patients.
This study is to retrospective investigate the effects of the simultaneous i.v. administration of lidocaine and ketamine on a four to six weeks interval in treatment refractory different chronic pain conditions.
- Conditions
- Chronic Pain
- Being tested
- Data collection for statistical analysis to identify patterns of treatment response/ non-response
- Keywords
- lidocaine, ketamine
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection for statistical analysis to identify patterns of treatment response/ non-responseOther
All data are restricted from the patient physical and electronic record of the Pain Management-Unit of the University Hospital Basel. No external data sources will be used. Records will be screened from 2012- May 2021. Variables collected are e.g. demography, medical diagnosis, psychological diagnosis, infusion therapy, medication, pain.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction over time (long lasting)
The primary outcome (pain reduction over time) is explorative and not comparative, therefore no hypothesis is formulated and only descriptive/explorative statistics will be applied. Pain reduction will be analysed descriptively. Categories: any pain reduction/ pain reduction >=50%/ pain free/ increase in pain (recorded as "no time stated/ < 2 weeks/ ≥2 weeks/full time in-between infusions"
Measured: up to 1 year
Secondary outcomes (1)
Change in Pain (acute reduction)
Numeric rating scale (NRS) at start of infusion (recorded as number from 0 = no pain to 10 = maximal pain)/ NRS at end of infusion (recorded as number from 0 to 10)
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start7 Sep 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Schneider, Dr. med., Principal investigator, Department of Anesthesiology University of Basel (USB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103319
- Sponsor's protocol ID
- 2021-01285; am21Schneider
- Status last verified
- May 2022
- First submitted
- 20 Oct 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Striebel J, Ruppen W, Schneider T. Simultaneous application of lidocaine and ketamine during ambulatory infusion therapy: a retrospective analysis. Pain Manag. 2023 Sep;13(9):539-553. doi: 10.2217/pmt-2023-0037. Epub 2023 Oct 18.
PubMed 37850330
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions - A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05103319
- Acronym / sponsor ID
- 2021-01285; am21Schneider
- Conditions
- Chronic Pain
- Keywords
- lidocaine, ketamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 2 Nov 2021 (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.
This study is to retrospective investigate the effects of the simultaneous intravenous (i.v.) administration of lidocaine and ketamine on a four to six weeks interval in treatment refractory different chronic pain conditions.
Detailed description
The use of intravenous infusion therapy with lidocaine or ketamine has been of interest in several chronic pain conditions. Studies showed a benefit in immediate pain reduction and even longer lasting pain relief for treatment approaches with lidocaine and ketamine.
While there is a broad database on the use of lidocaine and ketamine in chronic pain management as separate agents, very few pre-clinical animal studies have investigated the combined use of said analgesics and none of them reports their combined use in chronic pain patients.
This study is to retrospective investigate the effects of the simultaneous i.v. administration of lidocaine and ketamine on a four to six weeks interval in treatment refractory different chronic pain conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study only includes patients treated with lidocaine-ketamine infusions at the pain unit in the University Hospital of Basel (2012 -until May 2021) All data are extracted from the paper or electronic patient chart of the Pain Management-Unit of the University Hospital Basel. All data are collected retrospectively.
Key inclusion criteria (3 listed)
- ICD11 Medical diagnosis of chronic pain and its subcategories
- Treatment with intravenous lidocaine and ketamine infusions during the years of 2012 to May 2021 at our pain unit at the USB
- Patient is at least 18 years of age at the beginning of the first infusion treatment
Key exclusion criteria (3 listed)
- Patient is underage at the beginning of the first infusion treatment
- Documented written refusal of consent for research (general consent or specific study consent)
- Patients undergoing treatment with only lidocaine or ketamine respective
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 |
|---|---|---|
| Data collection for statistical analysis to identify patterns of treatment response/ non-responseAll data are restricted from the patient physical and electronic record of the Pain Management-Unit of the University Hospital Basel. No external data sources will be used. Records will be screened from 2012- May 2021. Variables collected are e.g. demography, medical diagnosis, psychological diagnosis, infusion therapy, medication, pain. | Other | – |
Primary outcome
Pain reduction over time (long lasting)
Time frame: up to 1 year
The primary outcome (pain reduction over time) is explorative and not comparative, therefore no hypothesis is formulated and only descriptive/explorative statistics will be applied. Pain reduction will be analysed descriptively. Categories: any pain reduction/ pain reduction >=50%/ pain free/ increase in pain (recorded as "no time stated/ < 2 weeks/ ≥2 weeks/full time in-between infusions"
1 secondary outcome
Change in Pain (acute reduction)
Time frame: up to 1 day
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 5 May 2022.
- Derived from this study: PubMed 37850330Striebel J, Ruppen W, Schneider T. Simultaneous application of lidocaine and ketamine during ambulatory infusion therapy: a retrospective analysis. Pain Manag. 2023 Sep;13(9):539-553. doi: 10.2217/pmt-2023-0037. Epub 2023 Oct 18.
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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.
Tobias Schneider, Dr. med. principal investigator
Department of Anesthesiology University 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 3 inclusion and 3 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 5 May 2022. 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?
Pain reduction over time (long lasting) (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103319, which also lists 1 linked publication.
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 5 May 2022.