RecruitingNot Applicable

Crystallization of LA and Adjuvant Mixtures in Cerebrospinal Fluid

Austria10 participantsStarted 2025-09-01

Plain-language summary

Different mixtures of local anesthetics or local anesthetics with adjuvants that are known to precipitate in vitro are tested in human cerebrospinal fluid (CSF). CSF is gained from patients with normal pressure hydrocephalus scheduled for elective lumbar puncture. Patients signed an ICF for leftover samples. CSF will be assessed for pH values at different timepoints (t0-t3; 0 to 60 minutes). In a second step six commonly used mixtures of LA with LA or LAs with adjuvants will be mixed using the following mixture ratios: ropivacaine 0.75% + lidocaine 2% (ratio 1:1), ropivacaine 0,75% + mepivacaine 2% (ratio 1:1), ropivacaine 0.75% + chloroprocaine 2% (ratio 1:1), lidocaine 2% + sodium bicarbonate 8.4% (ratio 1:0.1), ropivacaine 0.75% + lidocaine 2% + sodium bicarbonate 8.4% (ratio 1:1:0.1) and ropivacaine 0.75% + dexamethasone (1.5:1). The used mixture ratios are inspired by commonly mixtures described in the current literature and have been proven to precipitate in vitro. For every mixture, a Grade of Crystallisation will be determined at baseline without CSF and then at t0 (immediately) to t3 (60 minutes) every 15 minutes.

Who can participate

Age range

18 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with normal pressure hydrocephalus scheduled for elective lumbar puncture. Exclusion Criteria: * Age \< 18 years

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Grade of Crystallisation

Timeframe: 1 hour

Trial details

NCT IDNCT07442929

SponsorMedical University Innsbruck

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-01

Contact for this trial

Elisabeth Gasteiger, MD PhD

+43-512-504-22400 elisabeth.gasteiger@tirol-kliniken.at

View on ClinicalTrials.gov More Hydrocephalus trials