Spinal AnesthesiaNCT06497634
Effect of Spinal Needle Type on Optic Nerve Sheath Diameter
A study testing 25 PP, 25 Q and 27 Q in people with Spinal Anesthesia and Intracranial Pressure Change, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Spinal Anesthesia, Intracranial Pressure Change, Optic Nerve Sheath Diameter
- What is being tested?
- 25 PP, 25 Q and 27 Q
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I-II Risk Classification
- Elective orthopedic lower extremity surgery
- Using a tourniquet
- Spinal anesthesia
Who cannot join
- Bilateral tourniquet usage
- History of orbital trauma
- Optic nerve pathology
- Glaucoma
- Asthma
- Coronary obstructive or pulmonary disease
Show all 11Show fewer
- Previous corneal or intraocular surgery
- Increased intracranial pressure
- Coagulopathy
- Local site infection
- Refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcılar Training Research Hospital
Istanbul, Bagci̇lar
SEZEN KUMAS SOLAK, MD, +905055729494, sezenkumassolak@gmail.com
About this study
Official title: Effect of Needle Types and Diameters Using in Spinal Anesthesia on Optic Nerve Sheath Diameter; Prospective Randomized Study
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.
Read the 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.
- Conditions
- Spinal Anesthesia, Intracranial Pressure Change, Optic Nerve Sheath Diameter, Orthopedic Surgery, Cerebrospinal Fluid Leak
- Being tested
- 25 PP, 25 Q, 27 Q, Optic Nerve Sheath Measurement
- Medical subject headings
- Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 PPProcedure or 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 QProcedure or 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 QProcedure or 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 MeasurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 25w (25 gauge Whitacre needle) | Active comparator | Spinal anesthesia will be performed with 25 G pencil point needle (Whitacre) Receives: 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) Receives: 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) Receives: Procedure: 27 Q; Other: Optic Nerve Sheath Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter
The primary aim is to compare optic nerve sheath diameter (ONSD) according to the spinal needle type and size
Measured: ONSD changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
Secondary outcomes (3)
Blood pressure
The effect of needle type and size on blood pressure
Measured: Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
Hearth rate
The effect of needle type and size on hearth rate
Measured: Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
Oxygen saturation
The effect of needle type and size on oxygen saturation
Measured: Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start15 Aug 2024 (estimated)
- Primary completion25 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sezen Kumaş Solak, Bagcilar Training and Research Hospital
- Investigators
- sezen kumas solak, MD, Principal investigator, Bagcılar Training Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497634
- Sponsor's protocol ID
- Bagcilar1
- Status last verified
- Jul 2024
- First submitted
- 24 Mar 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share individual patient data
Publications
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.
PubMed 10925937Killer 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.
PubMed 12770980Tarkkila 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.
PubMed 1419942Kumas 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.
PubMed 39465875
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Needle Types and Diameters Using in Spinal Anesthesia on Optic Nerve Sheath Diameter; Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06497634
- Acronym / sponsor ID
- Bagcilar1
- Conditions
- Spinal Anesthesia, Intracranial Pressure Change, Optic Nerve Sheath Diameter, Orthopedic Surgery, Cerebrospinal Fluid Leak
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 25w (25 gauge Whitacre needle) | Active comparator | Procedure: 25 PP, Other: Optic Nerve Sheath MeasurementSpinal anesthesia will be performed with 25 G pencil point needle (Whitacre) |
| Group 25q (25 gauge Quincke needle) | Active comparator | Procedure: 25 Q, Other: Optic Nerve Sheath MeasurementSpinal anesthesia will be performed with 25 G sharp edge needle (Quincke) |
| Group 27q (27 gauge Quincke needle) | Active comparator | Procedure: 27 Q, Other: Optic Nerve Sheath MeasurementSpinal anesthesia will be performed with 27 G sharp edge needle (Quincke) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) I-II Risk Classification
- Elective orthopedic lower extremity surgery
- Using a tourniquet
- Spinal anesthesia
Key exclusion criteria (11 listed)
- Bilateral tourniquet usage
- History of orbital trauma
- Optic nerve pathology
- Glaucoma
- Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25 PPSpinal 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. | Procedure or surgery | Group 25w (25 gauge Whitacre needle) |
| 25 QSpinal 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. | Procedure or surgery | Group 25q (25 gauge Quincke needle) |
| 27 QSpinal 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. | Procedure or surgery | Group 27q (27 gauge Quincke needle) |
| Optic Nerve Sheath MeasurementSonographic 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. | Other | Group 25q (25 gauge Quincke needle), Group 25w (25 gauge Whitacre needle), Group 27q (27 gauge Quincke needle) |
Primary outcome
Optic nerve sheath diameter
Time frame: 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
3 secondary outcomes
Blood pressure
Time frame: Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
Hearth rate
Time frame: Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
Oxygen saturation
Time frame: Changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 10925937Reina 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.
- Background: PubMed 12770980Killer 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.
- Background: PubMed 1419942Tarkkila 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.
- Derived from this study: PubMed 39465875Kumas 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.
- Individual participant dataSharing planned: No. The investigators will not share individual patient data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sezen kumas solak, MD principal investigator
Bagcılar Training Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25 PP, 25 Q and 27 Q in people with Spinal Anesthesia and Intracranial Pressure Change, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sezen kumas solak, MD (+905055729494, sezenkumassolak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter (time frame: ONSD changes from baseline, at 5 minutes, 15 minutes, 24 hours after spinal anesthesia and opening the tourniquet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06497634, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.