Clinical trial NCT05103319: Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: lidocaine
ketamine
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Pain reduction over time (long lasting)
timeFrame: up to 1 year
Secondary outcomes:
measure: Change in Pain (acute reduction)
timeFrame: up to 1 day
Other outcomes:
measure: Change in activity
timeFrame: up to 1 year
measure: Change in sleep
timeFrame: up to 1 year
measure: Change in mood
timeFrame: up to 1 year
measure: Number of side effects
timeFrame: up to 1 year
measure: Change in medication
timeFrame: up to 1 year
measure: Infusion therapy
timeFrame: up to 1 year
Locations:
city: Basel
country: Switzerland
facility: Department of Anesthesiology, University of Basel (USB)
Study officials:
affiliation: Department of Anesthesiology University of Basel (USB)
name: Tobias Schneider, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: