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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05103319
• Other study ID #: 2021-01285; am21Schneider
• Status: Completed
• Start date: September 7, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Department of Anesthesiology, University of Basel (USB)	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in activity	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)	up to 1 year
Other	Change in sleep	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)	up to 1 year
Other	Change in mood	Categories: mood brightened/ mood worsened (recorded as "no time stated/ < 2 weeks/ =2 weeks/full time in-between infusions" for each category)	up to 1 year
Other	Number of side effects	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)	up to 1 year
Other	Change in medication	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	up to 1 year
Other	Infusion therapy	Categories: Amount of infusions totally received (recorded as number)/ time frame of infusion therapy (date at beginning/ date at end)	up to 1 year
Primary	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"	up to 1 year
Secondary	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)	up to 1 day