Health TrialsbyHealthPanel

Crystallization of LA and Adjuvant Mixtures in Cerebrospinal Fluid

ConditionHydrocephalus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University Innsbruck

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with normal pressure hydrocephalus scheduled for elective lumbar puncture.

Disqualifiers

Age < 18 years

Trial population

patients with normal pressure hydrocephalus scheduled for elective lumbar puncture.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10 Participants
are grouped into 1 trial group
Group A: Patients with normal pressure hydrocephalus scheduled for elective lumbar puncture

Trial outcomes

Primary outcomes

1

Grade of Crystallisation

For the grading of detectable precipitations, a scale from 0 (no signs of precipitation / single particulates \< 10 μm) to 5 (heavy polymorphic crystallization: \> 100 solid bodies \> 10 μm, and \> 1 solid body \> 50 μm or \> 1 solid body \> 100 μm) will be used.

Time frame
1 hour

Secondary outcomes

1

pH value and of CSF and CSF LA mixtures

pH value

Time frame
1 hour
2

pCO2 of CSF and CSF LA mixtures

pCO2 in mmHg

Time frame
1 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University Innsbruck

Lead sponsor

Source ClinicalTrials.gov
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