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
|Condition or disease||Intervention/treatment|
|Chronic Pain||Other: Data collection for statistical analysis to identify patterns of treatment response/ non-response|
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 Type :||Observational|
|Actual Enrollment :||319 participants|
|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|
- 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.
- 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"
- 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)
- 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)
- 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)
- 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)
- 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)
- 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
- 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)
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
|Department of Anesthesiology, University of Basel (USB)|
|Basel, Switzerland, 4031|
|Principal Investigator:||Tobias Schneider, Dr. med.||Department of Anesthesiology University of Basel (USB)|