Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-24
Brief Title:
Effect of Spinal Needle Type on Optic Nerve Sheath Diameter
Sponsor:
Bagcilar Training and Research Hospital
Organization:
Bagcilar Training and Research Hospital
Study Overview
Official Title:
Effect of Needle Types and Diameters Using in Spinal Anesthesia on Optic Nerve Sheath Diameter Prospective Randomized Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The optic nerve sheath is a continuation of the dura mater extending along the subarachnoid space surrounding the optic nerve Consequently changes in intracranial pressure cause an augmentation or contraction in the diameter of the optic nerve sheath which is coreleted with intracranial pressure 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 Optic nerve sheath diameter ONSD measurements will be performed before spinal anesthesia and 5 minutes 15 minutes24 hours after spinal block respectivelyThe 4th measurement will be performed after tourniquet is opened 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 on upper eyelid 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
Detailed Description:
Optic nerve sheath diameter ONSD measured with US emerges as a standout intracranial pressure reflector among non-invasive modalities as a bed side assessment Different types of needles used in spinal anesthesia cause different lesions in the dura Lesions created by Quincke needles are small and clean-cut opening in the dural membrane while those from Whitacre needles result in a more traumatic opening Also it is known that CSF leakage increase when larger needles are used As one of postspinal headache mechanism is decrease in the intracranial pressure the investigators aim to investigate the ONSD changes reflecting intracranial pressure changes
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None