Crystallization of ropivacaine and bupivacaine when mixed with different adjuvants: a semiquantitative light microscopy analysis.
Elisabeth Hoerner, Ottokar Stundner, Guenther Putz...
https://pubmed.ncbi.nlm.nih.gov/35738668Actively Recruiting
Age: 18Years +
All Genders
ID07442929
Crystallization of Local Anesthetic and Adjuvant Mixtures in Cerebrospinal Fluid as a Model for Interstitial Space - a Semiquantitative in Vitro Trial
Led by Medical University Innsbruck · Updated on 2026-03-02
10
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This research investigates how different mixtures of local anesthetics and their combinations with other drugs behave when mixed with human cerebrospinal fluid (CSF). The study focuses on patients with normal pressure hydrocephalus who are scheduled for an elective lumbar puncture. The main goal is to analyze how these drug mixtures crystallize over time, which is important for understanding their behavior in the body. The study evaluates six specific mixtures of local anesthetics and adjuvants, including combinations like ropivacaine with lidocaine, mepivacaine, chloroprocaine, sodium bicarbonate, and dexamethasone in various ratios. These mixtures are tested in vitro by mixing with CSF collected from patients. Researchers measure the grade of crystallization at the start and at multiple intervals up to 60 minutes, as well as pH and pCO2 values of the mixtures. Participants provide leftover CSF samples obtained during their scheduled lumbar puncture. The samples are assessed at baseline and every 15 minutes for one hour to track crystallization and chemical changes. The primary outcome is the grade of crystallization within this hour. Secondary outcomes include pH and pCO2 levels of the CSF and mixtures. The study spans from September 2025 to September 2026 under the Medical University Innsbruck.
CONDITIONS
Brief Title
Crystallization of LA and Adjuvant Mixtures in Cerebrospinal Fluid
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with normal pressure hydrocephalus scheduled for elective lumbar puncture
- Age 18 years or older
You will not qualify if you...
- Age under 18 years
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Diagnostic Evaluation
Duration - 1 day
Participants undergo an elective lumbar puncture to provide cerebrospinal fluid (CSF) samples for analysis.
1 visit (in-person) for lumbar puncture and sample collection
Long-term Monitoring
Duration - 1 hour
Collected CSF samples are assessed for pH values and crystallization grades over 60 minutes at multiple timepoints.
Samples assessed at baseline and every 15 minutes up to 60 minutes
Trial Site Locations
Total: 1 location
1
Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
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Research Team
E
Elisabeth Gasteiger, MD PhD
L
Lukas Gasteiger, MD PD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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