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

NCT05103319 | Completed

• 1 other identifier: 2021-01285; am21Schneider
• Study Type: observational
• Target: 319
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

lidocaine; ketamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Pain (acute reduction)

  up to 1 day

Other Outcomes (6)

• Change in activity

  up to 1 year

• Change in sleep

  up to 1 year

• Change in mood

  up to 1 year

Interventions

Data collection for statistical analysis to identify patterns of treatment response/ non-response OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Anesthesiology, University of Basel (USB)

Basel, 4031, Switzerland

Location

Related Publications (1)

• Striebel J, Ruppen W, Schneider T. Simultaneous application of lidocaine and ketamine during ambulatory infusion therapy: a retrospective analysis. Pain Manag. 2023 Sep;13(9):539-553. doi: 10.2217/pmt-2023-0037. Epub 2023 Oct 18.

  PMID: 37850330 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tobias Schneider, Dr. med.

  Department of Anesthesiology University of Basel (USB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 2, 2021
• Study Start: September 7, 2021
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

CH (1)