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CompletedNCT07442929Updated Aug 25, 2026

Crystallization of LA and Adjuvant Mixtures in Cerebrospinal Fluid

An observational study in Hydrocephalus, sponsored by Medical University Innsbruck. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Medical University Innsbruck · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Hydrocephalus

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Keywords

  • local anesthetics;
  • local anesthetic mixtures
  • cerebrospinal fluid
  • in vitro
  • crystallization
  • pH
  • adjuvants
03

In context

Hydrocephalus

210 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.

This study's enrollment of 2 is below the median of 60 across 98 observational studies indexed under Hydrocephalus.

Browse Hydrocephalus studies →

Lead sponsor

Medical University Innsbruck is the lead sponsor of 182 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with normal pressure hydrocephalus scheduled for elective lumbar puncture.

Inclusion criteria

  • Patients with normal pressure hydrocephalus scheduled for elective lumbar puncture.

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with normal pressure hydrocephalus scheduled for elective lumbar puncture

    Patients with normal pressure hydrocephalus scheduled for elective lumbar puncture

06

What researchers measure

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

07

Study locations

1 site
  • Medical University Innsbruck
    Innsbruck, Tyrol 6020, Austria
08

References and documents

Publications

  • Hoerner E, Stundner O, Putz G, Steinfeldt T, Mathis S, Gasteiger L. Crystallization of ropivacaine and bupivacaine when mixed with different adjuvants: a semiquantitative light microscopy analysis. Reg Anesth Pain Med. 2022 Jun 23:rapm-2022-103610. doi: 10.1136/rapm-2022-103610. Online ahead of print. PubMed 35738668 ↗

Individual participant data

Plan to share: Yes — Data will only be shared on a reasonable request.

Supporting information: Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07442929
Lead sponsor
Medical University Innsbruck
Responsible party
Sponsor
First posted
Mar 2, 2026
Start date
Sep 1, 2025
Primary completion
Aug 20, 2026
Completion
Aug 20, 2026
Last update
Aug 25, 2026

Study contacts

Elisabeth Gasteiger, MD PhD
principal investigator · Medical Unicersity Innsbruck

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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