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

Completed

• Conditions: Chronic Pain

• Registration Number: NCT05103319
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2021-09-07
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-11-02
• Primary Completion: 2022-01-30
• Study Completion: 2022-01-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Anesthesiology, University of Basel (USB); 🇨🇭 Basel, Switzerland