Effect of Spinal Needle Type on Optic Nerve Sheath Diameter
NCT ID: NCT06497634
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
165 participants
INTERVENTIONAL
2024-08-15
2024-12-30
Brief Summary
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Detailed Description
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Participants undergoing lower extremity operations (ankle, distal tibia and fibula surgeries) using a tourniquet under spinal anesthesia will be investigated. Spinal anesthesia will be performed with a 25 G Whitacre, 25 G Quincke, or 27 G Quincke needle, depending on the study group. ONSD measurements will be performed before spinal anesthesia as baseline; and 5 minutes, 15 minutes, 24 hours after spinal block, respectively. Also a measurement will be performed after opening of the surgical tourniquet. Measurements will be done with 15 MHz linear ultrasound (US) probe in B mode, 3 mm behind the posterior globe in the transverse plane from both eyes. Values will be recorded numerically. The impact of spinal anesthesia administered using various needle designs (Quincke and Whitacre) and sizes (25G-27G) on intracranial pressure will be investigated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group 25w (25 gauge Whitacre needle)
Spinal anesthesia will be performed with 25 G pencil point needle (Whitacre)
25 PP
Spinal anesthesia will be performed in sitting position, with 25 G pencil point needle (Whitacre -Egemen®) midline through the L4-5 or L5-S1 interspace, parallel to the dural fibers. Upon clear cerebrospinal fluid (CSF) detection, the needle apertures will be turned towards the cephalad direction, and 3 ml (15 mg) of 0.5% hyperbaric bupivacaine (Marcaine Heavy ®) will be injected into the intrathecal space.
Optic Nerve Sheath Measurement
Sonographic measurement of ONSD (EsaoteMyLabFive, Cenova, Italy) for all patients will be performed by a single experienced anesthesiologist. After a thin gel layer apply to the upper eyelid, the patient in the supine position and with the eyes closed, using a 6-13 MHz linear probe, optic sheath nerve measurement will be done 3 mm behind the optic globe, with a total of three measurements of which the final value will be recorded.The measurement will be repeated five times using US guidance at the following time points: T0 (pre-anesthesia), T1 (5 minutes after spinal block), T2 (15 minutes after spinal block, T3 (tourniquet opening), and T4 (24 hours after spinal block ) respectively.
Group 25q (25 gauge Quincke needle)
Spinal anesthesia will be performed with 25 G sharp edge needle (Quincke)
25 Q
Spinal anesthesia will be performed in sitting position, with 25 G sharp edge needle (Quincke -Egemen®) midline through the L4-5 or L5-S1 interspace, parallel to the dural fibers. Upon clear cerebrospinal fluid (CSF) detection, the needle apertures will be turned towards the cephalad direction, and 3 ml (15 mg) of 0.5% hyperbaric bupivacaine (Marcaine Heavy ®) will be injected into the intrathecal space.
Optic Nerve Sheath Measurement
Sonographic measurement of ONSD (EsaoteMyLabFive, Cenova, Italy) for all patients will be performed by a single experienced anesthesiologist. After a thin gel layer apply to the upper eyelid, the patient in the supine position and with the eyes closed, using a 6-13 MHz linear probe, optic sheath nerve measurement will be done 3 mm behind the optic globe, with a total of three measurements of which the final value will be recorded.The measurement will be repeated five times using US guidance at the following time points: T0 (pre-anesthesia), T1 (5 minutes after spinal block), T2 (15 minutes after spinal block, T3 (tourniquet opening), and T4 (24 hours after spinal block ) respectively.
Group 27q (27 gauge Quincke needle)
Spinal anesthesia will be performed with 27 G sharp edge needle (Quincke)
27 Q
Spinal anesthesia will be performed in sitting position, with 27 G sharp edge needle (Quincke -Egemen®) midline through the L4-5 or L5-S1 interspace, parallel to the dural fibers. Upon clear cerebrospinal fluid (CSF) detection, the needle apertures will be turned towards the cephalad direction, and 3 ml (15 mg) of 0.5% hyperbaric bupivacaine (Marcaine Heavy ®) will be injected into the intrathecal space.
Optic Nerve Sheath Measurement
Sonographic measurement of ONSD (EsaoteMyLabFive, Cenova, Italy) for all patients will be performed by a single experienced anesthesiologist. After a thin gel layer apply to the upper eyelid, the patient in the supine position and with the eyes closed, using a 6-13 MHz linear probe, optic sheath nerve measurement will be done 3 mm behind the optic globe, with a total of three measurements of which the final value will be recorded.The measurement will be repeated five times using US guidance at the following time points: T0 (pre-anesthesia), T1 (5 minutes after spinal block), T2 (15 minutes after spinal block, T3 (tourniquet opening), and T4 (24 hours after spinal block ) respectively.
Interventions
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25 PP
Spinal anesthesia will be performed in sitting position, with 25 G pencil point needle (Whitacre -Egemen®) midline through the L4-5 or L5-S1 interspace, parallel to the dural fibers. Upon clear cerebrospinal fluid (CSF) detection, the needle apertures will be turned towards the cephalad direction, and 3 ml (15 mg) of 0.5% hyperbaric bupivacaine (Marcaine Heavy ®) will be injected into the intrathecal space.
25 Q
Spinal anesthesia will be performed in sitting position, with 25 G sharp edge needle (Quincke -Egemen®) midline through the L4-5 or L5-S1 interspace, parallel to the dural fibers. Upon clear cerebrospinal fluid (CSF) detection, the needle apertures will be turned towards the cephalad direction, and 3 ml (15 mg) of 0.5% hyperbaric bupivacaine (Marcaine Heavy ®) will be injected into the intrathecal space.
27 Q
Spinal anesthesia will be performed in sitting position, with 27 G sharp edge needle (Quincke -Egemen®) midline through the L4-5 or L5-S1 interspace, parallel to the dural fibers. Upon clear cerebrospinal fluid (CSF) detection, the needle apertures will be turned towards the cephalad direction, and 3 ml (15 mg) of 0.5% hyperbaric bupivacaine (Marcaine Heavy ®) will be injected into the intrathecal space.
Optic Nerve Sheath Measurement
Sonographic measurement of ONSD (EsaoteMyLabFive, Cenova, Italy) for all patients will be performed by a single experienced anesthesiologist. After a thin gel layer apply to the upper eyelid, the patient in the supine position and with the eyes closed, using a 6-13 MHz linear probe, optic sheath nerve measurement will be done 3 mm behind the optic globe, with a total of three measurements of which the final value will be recorded.The measurement will be repeated five times using US guidance at the following time points: T0 (pre-anesthesia), T1 (5 minutes after spinal block), T2 (15 minutes after spinal block, T3 (tourniquet opening), and T4 (24 hours after spinal block ) respectively.
Eligibility Criteria
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Inclusion Criteria
* Elective orthopedic lower extremity surgery
* Using a tourniquet
* Spinal anesthesia
Exclusion Criteria
* History of orbital trauma
* Optic nerve pathology
* Glaucoma
* Asthma
* Coronary obstructive or pulmonary disease
* Previous corneal or intraocular surgery
* Increased intracranial pressure
* Coagulopathy
* Local site infection
* Refusing to participate in the study
18 Years
40 Years
ALL
No
Sponsors
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Bagcilar Training and Research Hospital
OTHER_GOV
Responsible Party
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Sezen Kumaş Solak
Principle Investigator
Principal Investigators
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sezen kumas solak, MD
Role: PRINCIPAL_INVESTIGATOR
Bagcılar Training Research Hospital
Locations
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Bagcılar Training Research Hospital
Istanbul, Bagci̇lar, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Reina MA, de Leon-Casasola OA, Lopez A, De Andres J, Martin S, Mora M. An in vitro study of dural lesions produced by 25-gauge Quincke and Whitacre needles evaluated by scanning electron microscopy. Reg Anesth Pain Med. 2000 Jul-Aug;25(4):393-402. doi: 10.1053/rapm.2000.7622.
Killer HE, Laeng HR, Flammer J, Groscurth P. Architecture of arachnoid trabeculae, pillars, and septa in the subarachnoid space of the human optic nerve: anatomy and clinical considerations. Br J Ophthalmol. 2003 Jun;87(6):777-81. doi: 10.1136/bjo.87.6.777.
Tarkkila PJ, Heine H, Tervo RR. Comparison of Sprotte and Quincke needles with respect to post dural puncture headache and backache. Reg Anesth. 1992 Sep-Oct;17(5):283-7.
Kumas Solak S, Demirgan S, Karali E, Selcan A. Effect of needle types and diameters using in spinal anesthesia on optic nerve sheath diameter: Prospective randomized study. Medicine (Baltimore). 2024 Oct 11;103(41):e40003. doi: 10.1097/MD.0000000000040003.
Other Identifiers
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Bagcilar1
Identifier Type: -
Identifier Source: org_study_id
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