Health TrialsbyHealthPanel

Effect of Spinal Needle Type on Optic Nerve Sheath Diameter

ConditionsSpinal AnesthesiaIntracranial Pressure ChangeOptic Nerve Sheath DiameterOrthopedic SurgeryCerebrospinal Fluid Leak
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorBagcilar Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) I-II Risk Classification

Elective orthopedic lower extremity surgery

Using a tourniquet

Spinal anesthesia

Disqualifiers

Bilateral tourniquet usage

History of orbital trauma

Optic nerve pathology

Glaucoma

Trial design

Design model

Parallel

Treatments tested in this trial

  • 25 PP

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Other intervention

    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.

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: Group 25w (25 gauge Whitacre needle)Active comparator 2 interventions
Group B: Group 25q (25 gauge Quincke needle)Active comparator 2 interventions
Group C: Group 27q (27 gauge Quincke needle)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Optic nerve sheath diameter

The primary aim is to compare optic nerve sheath diameter (ONSD) according to the spinal needle type and size

Time frame
ONSD changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet

Secondary outcomes

1

Blood pressure

The effect of needle type and size on blood pressure

Time frame
Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
2

Hearth rate

The effect of needle type and size on hearth rate

Time frame
Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
3

Oxygen saturation

The effect of needle type and size on oxygen saturation

Time frame
Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet

Other outcomes

1

Nause and vomiting

Number of participants with nause and vomiting in first 24 hours

Time frame
First 24 hours
2

Double vision

Number of participants with double vision in first 24 hours

Time frame
First 24 hours
3

Headache

Number of participants with headache in first 24 hours

Time frame
First 24 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bagcilar Training and Research Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: