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Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions

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ClinicalTrials.gov Identifier: NCT05103319
Recruitment Status : Completed
First Posted : November 2, 2021
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Chronic Pain Other: Data collection for statistical analysis to identify patterns of treatment response/ non-response

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
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Study Type : Observational
Actual Enrollment : 319 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : September 7, 2021
Actual Primary Completion Date : January 30, 2022
Actual Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Groups and Cohorts
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Intervention Details:
  • Other: Data collection for statistical analysis to identify patterns of treatment response/ non-response
    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.

Outcome Measures
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Primary Outcome Measures :
  1. 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"


Secondary Outcome Measures :
  1. Change in Pain (acute reduction) [ Time Frame: up to 1 day ]
    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)


Other Outcome Measures:
  1. Change in activity [ Time Frame: up to 1 year ]
    Categories: increased activity/ quantifiable increased activity/ activity without restrictions/ decreased activity (recorded as "no time stated/ < 2 weeks/ ≥2 weeks/full time in-between infusions" for each category)

  2. Change in sleep [ Time Frame: up to 1 year ]
    Categories: increased quality of sleep/ decreased quality of sleep (recorded as "no time stated/ < 2 weeks/ ≥2 weeks/full time in-between infusions" for each category)

  3. Change in mood [ Time Frame: up to 1 year ]
    Categories: mood brightened/ mood worsened (recorded as "no time stated/ < 2 weeks/ ≥2 weeks/full time in-between infusions" for each category)

  4. Number of side effects [ Time Frame: up to 1 year ]
    Categories: waking reactions such as hallucinations, vivid dreams, nightmares, confusion, fidgetiness, agitation/ raise in liver enzymes/ sight disorders, diplopia/ anxiety/ nystagmus, tonic and clonic movement, increased muscle tone, increased intracranial pressure/ dizziness/ tachycardia/ bradycardia/ hypertension/ hypotension/ respiratory depression/ nausea, vomiting/ erythema/ acute kidney impairment, hemorrhagic cystitis, hydronephrosis/ signs and symptom of cns toxicity (convulsions, paraesthesia circumoralis, numbness of tongue, hyperacusis, tremor, tinnitus, dysarthria, cns depression)

  5. Change in medication [ Time Frame: up to 1 year ]
    Categories: Substance name (recorded as free text)/ amount of substance at start (recorded in mg)/ date at start/ amount of substance after change (recorded in mg)/ date of change

  6. Infusion therapy [ Time Frame: up to 1 year ]
    Categories: Amount of infusions totally received (recorded as number)/ time frame of infusion therapy (date at beginning/ date at end)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05103319


Locations
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Switzerland
Department of Anesthesiology, University of Basel (USB)
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Tobias Schneider, Dr. med. Department of Anesthesiology University of Basel (USB)
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT05103319    
Other Study ID Numbers: 2021-01285; am21Schneider
First Posted: November 2, 2021    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
lidocaine
ketamine
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations