Cerebrospinal Fluid Leak, Intracranial Pressure Change, Optic Nerve Sheath Diameter, Orthopedic Surgery, Spinal Anesthesia
Conditions
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.
Interventions
PROCEDURE25 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.
PROCEDURE25 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.
PROCEDURE27 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.
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.
Sponsors
Bagcilar Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optic nerve sheath diameter | ONSD changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet | The primary aim is to compare optic nerve sheath diameter (ONSD) according to the spinal needle type and size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet | The effect of needle type and size on blood pressure |
| Hearth rate | Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet | The effect of needle type and size on hearth rate |
| Oxygen saturation | Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet | The effect of needle type and size on oxygen saturation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Double vision | First 24 hours | Number of participants with double vision in first 24 hours |
| Headache | First 24 hours | Number of participants with headache in first 24 hours |
| Nause and vomiting | First 24 hours | Number of participants with nause and vomiting in first 24 hours |
Countries
Turkey (Türkiye)
Contacts
Primary Contactsezen kumas solak, MD
Outcome results
None listed