Chronic Pain
Conditions
Keywords
lidocaine, ketamine
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.
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.
Interventions
OTHERData 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.
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction over time (long lasting) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain (acute reduction) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in mood | 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 | 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 activity | 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) |
| Infusion therapy | up to 1 year | Categories: Amount of infusions totally received (recorded as number)/ time frame of infusion therapy (date at beginning/ date at end) |
| Change in medication | 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 |
| Change in sleep | 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) |
Countries
Switzerland
Outcome results
None listed