Clinical trial NCT06497634: Effect of Spinal Needle Type on Optic Nerve Sheath Diameter
Official title: Effect of Needle Types and Diameters Using in Spinal Anesthesia on Optic Nerve Sheath Diameter; Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Anesthesia
Intracranial Pressure Change
Optic Nerve Sheath Diameter
Orthopedic Surgery
Cerebrospinal Fluid Leak
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-12
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 minutes,,24 hours after spinal block, respectively.The 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.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-II Risk Classification
* Elective orthopedic lower extremity surgery
* Using a tourniquet
* Spinal anesthesia

Exclusion Criteria:

* Bilateral tourniquet usage
* 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

Primary outcomes:
measure: Optic nerve sheath diameter
timeFrame: ONSD changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
Secondary outcomes:
measure: Blood pressure
timeFrame: Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
measure: Hearth rate
timeFrame: Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
measure: Oxygen saturation
timeFrame: Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
Other outcomes:
measure: Nause and vomiting
timeFrame: First 24 hours
measure: Double vision
timeFrame: First 24 hours
measure: Headache
timeFrame: First 24 hours
Locations:
city: Istanbul
country: Turkey
facility: Bagcılar Training Research Hospital
state: Bagci̇lar
Study officials:
affiliation: Bagcılar Training Research Hospital
name: sezen kumas solak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.