Effect of Spinal Needle Type on Optic Nerve Sheath Diameter

NCT06497634 | Not Yet Recruiting

• 1 other identifier: Bagcilar1
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia; Intracranial Pressure Change; Optic Nerve Sheath Diameter; Orthopedic Surgery; Cerebrospinal Fluid Leak

Outcome Measures

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

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

Secondary Outcomes (3)

• Blood pressure

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

• Hearth rate

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

• Oxygen saturation

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

Other Outcomes (3)

• Nause and vomiting

  First 24 hours

• Double vision

  First 24 hours

• Headache

  First 24 hours

Study Arms (3)

Group 25w (25 gauge Whitacre needle)

ACTIVE COMPARATOR

Spinal anesthesia will be performed with 25 G pencil point needle (Whitacre)

Procedure: 25 PP; Other: Optic Nerve Sheath Measurement

Group 25q (25 gauge Quincke needle)

ACTIVE COMPARATOR

Spinal anesthesia will be performed with 25 G sharp edge needle (Quincke)

Procedure: 25 Q; Other: Optic Nerve Sheath Measurement

Group 27q (27 gauge Quincke needle)

ACTIVE COMPARATOR

Spinal anesthesia will be performed with 27 G sharp edge needle (Quincke)

Procedure: 27 Q; Other: Optic Nerve Sheath Measurement

Interventions

25 PP PROCEDURE

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.

Group 25w (25 gauge Whitacre needle)

25 Q PROCEDURE

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.

Group 25q (25 gauge Quincke needle)

27 Q PROCEDURE

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.

Group 27q (27 gauge Quincke needle)

Optic Nerve Sheath Measurement OTHER

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); Group 25w (25 gauge Whitacre needle); Group 27q (27 gauge Quincke needle)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Bagcılar Training Research Hospital

Istanbul, Bagci̇lar, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 10925937 BACKGROUND

• 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.

  PMID: 12770980 BACKGROUND

• 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.

  PMID: 1419942 BACKGROUND

• 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.

  PMID: 39465875 DERIVED

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• sezen kumas solak, MD

  Bagcılar Training Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sezen kumas solak, MD

CONTACT

+905055729494; sezenkumassolak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: July 12, 2024
• Study Start: August 15, 2024
• Primary Completion: December 25, 2024
• Study Completion: December 30, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)