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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with normal pressure hydrocephalus scheduled for elective lumbar puncture | Patients with normal pressure hydrocephalus scheduled for elective lumbar puncture |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| pH value and of CSF and CSF LA mixtures | pH value | 1 hour |
| pCO2 of CSF and CSF LA mixtures | pCO2 in mmHg | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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patients with normal pressure hydrocephalus scheduled for elective lumbar puncture.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth Gasteiger, MD PhD | Contact | +43-512-504-22400 | elisabeth.gasteiger@tirol-kliniken.at | |
| Lukas Gasteiger, MD PD | Contact | +43-512-504-22400 | lukas.gasteiger@tirol-kliniken.at |
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Gasteiger, MD PhD | Medical Unicersity Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck | Recruiting | Innsbruck | Tyrol | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35738668 | Background | 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. |
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Data will only be shared on a reasonable request.
Data will only be shared on a reasonable request.
Data will only be shared on a reasonable request.
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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