Spinal AnaesthesiaNCT07333703
MRI-Based Estimation of Lumbar CSF Volume and Its Clinical Impact on Spinal Anaesthesia
An observational study of Spinal Anaesthesia and Magnetic Resonance Imaging (MRI), run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to investigate the clinical impact of lumbar cerebrospinal fluid (CSF) volume on spinal anesthesia characteristics. A total of 40 adult patients, aged 18 to 75 years and classified as ASA physical status I-III, who had undergone 3D T2-weighted lumbosacral MRI within the past… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Anaesthesia, Magnetic Resonance Imaging (MRI), Lumbosacral Spinal Stenosis
- What is being tested?
- Distribution of spinal anesthetic agent
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 15 Nov 2025
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged between 18 and 75 years, classified as ASA physical status I-III, who had undergone 1.5 Tesla lumbosacral MRI within the last six months.
Who may be able to join
- Aged 18-75 years
- ASA physical status I-III
- Who had undergone 1.5 Tesla lumbosacral MRI within the last six months
Who cannot join
- The presence of neurological diseases and allergy to local anesthetics
- Refusal to undergo spinal anesthesia
- Contraindications for spinal anesthesia
- Local infection at the lumbar site
Trial locations and contacts
1 site in 1 country.
About this study
This prospective observational study aims to investigate the clinical impact of lumbar cerebrospinal fluid (CSF) volume on spinal anesthesia characteristics. A total of 40 adult patients, aged 18 to 75 years and classified as ASA physical status I-III, who had undergone 3D T2-weighted lumbosacral MRI within the past six months, were enrolled. Intrathecal anesthesia was administered with 4 mL (20 mg) of 0.5% hyperbaric bupivacaine via the L3-L4 interspace in a sitting position.
CSF volume was measured from the lower half of the L1 vertebral body to the sacral end using the volume of interest (VOI) method on sagittal 3D T2-weighted MR images, processed with the ITK-SNAP software. Primary outcome was the correlation between lumbosacral CSF volume and peak sensory block level. Secondary outcomes included correlations with the onset time and duration of sensory and motor block, two-segment regression time, and patient characteristics such as height, weight, BMI, and age.
Read the detailed description
Spinal anesthesia is a widely used and effective alternative to general anesthesia for surgeries performed below the L₁-L₂ level, where the spinal cord ends. However, the distribution and duration of local anesthetics in spinal anesthesia are often unpredictable due to factors such as anesthetic dose, injection speed and location, patient position, age, and body habitus. One important yet less predictable factor is the individual variability in cerebrospinal fluid (CSF) volume, especially in the lumbosacral region. Since CSF dilutes the intrathecally administered anesthetic, differences in CSF volume can significantly impact drug concentration and, consequently, block level and duration.
Advancements in imaging techniques such as ultrasound and MRI have contributed to more accurate estimations of CSF volume. While most studies have used ultrasound-based estimations, MRI-based evaluations remain limited. In this study, we aimed to investigate the effect of lumbosacral CSF volume, measured via 3D T₂-weighted MRI, on the duration and extent of spinal anesthesia. Understanding this relationship could improve predictability in spinal anesthesia and enhance personalized anesthetic planning.
- Conditions
- Spinal Anaesthesia, Magnetic Resonance Imaging (MRI), Lumbosacral Spinal Stenosis, Anaesthesia
- Being tested
- Distribution of spinal anesthetic agent
- Keywords
- Spinal Anaesthesia, Peak sensory block level, Lumbosacral volume, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distribution of spinal anesthetic agentProcedure or surgery
Under aseptic conditions and in a sitting position, a 25G spinal needle was inserted through the midline at the L₃-L₄ intervertebral space, advancing parallel to the dura fibers. Upon clear cerebrospinal fluid (CSF) flow, the needle bevel was oriented cephalad and 20 mg of 0.5% hyperbaric bupivacaine was injected into the intrathecal space. Patients were kept supine for 5 minutes before sensory block was assessed by pinprick test from the midclavicular line. All spinal anesthesia procedures were performed by the same experienced anesthesiologist.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was to assess the correlation between lumbosacral CSF volume and peak sensory block level.
Measured: From enrollment to the end of study 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Feb 2023
- Primary completion1 Sep 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal AnaesthesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333703
- Sponsor's protocol ID
- SUKAEK-2022/1/14
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stienstra R, Greene NM. Factors affecting the subarachnoid spread of local anesthetic solutions. Reg Anesth. 1991 Jan-Feb;16(1):1-6. No abstract available.
PubMed 2007097
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-Based Estimation of Lumbar CSF Volume and Its Clinical Impact on Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT07333703
- Acronym / sponsor ID
- SUKAEK-2022/1/14
- Conditions
- Spinal Anaesthesia, Magnetic Resonance Imaging (MRI), Lumbosacral Spinal Stenosis, Anaesthesia
- Keywords
- Spinal Anaesthesia, Peak sensory block level, Lumbosacral volume, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 12 Jan 2026 (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.
This prospective observational study aims to investigate the clinical impact of lumbar cerebrospinal fluid (CSF) volume on spinal anesthesia characteristics. A total of 40 adult patients, aged 18 to 75 years and classified as ASA physical status I-III, who had undergone 3D T2-weighted lumbosacral MRI within the past six months, were enrolled. Intrathecal anesthesia was administered with 4 mL (20 mg) of 0.5% hyperbaric bupivacaine via the L3-L4 interspace in a sitting position.
CSF volume was measured from the lower half of the L1 vertebral body to the sacral end using the volume of interest (VOI) method on sagittal 3D T2-weighted MR images, processed with the ITK-SNAP software. Primary outcome was the correlation between lumbosacral CSF volume and peak sensory block level. Secondary outcomes included correlations with the onset time and duration of sensory and motor block, two-segment regression time, and patient characteristics such as height, weight, BMI, and age.
Detailed description
Spinal anesthesia is a widely used and effective alternative to general anesthesia for surgeries performed below the L₁-L₂ level, where the spinal cord ends. However, the distribution and duration of local anesthetics in spinal anesthesia are often unpredictable due to factors such as anesthetic dose, injection speed and location, patient position, age, and body habitus. One important yet less predictable factor is the individual variability in cerebrospinal fluid (CSF) volume, especially in the lumbosacral region. Since CSF dilutes the intrathecally administered anesthetic, differences in CSF volume can significantly impact drug concentration and, consequently, block level and duration.
Advancements in imaging techniques such as ultrasound and MRI have contributed to more accurate estimations of CSF volume. While most studies have used ultrasound-based estimations, MRI-based evaluations remain limited. In this study, we aimed to investigate the effect of lumbosacral CSF volume, measured via 3D T₂-weighted MRI, on the duration and extent of spinal anesthesia. Understanding this relationship could improve predictability in spinal anesthesia and enhance personalized anesthetic planning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged between 18 and 75 years, classified as ASA physical status I-III, who had undergone 1.5 Tesla lumbosacral MRI within the last six months.
Key inclusion criteria (3 listed)
- Aged 18-75 years
- ASA physical status I-III
- Who had undergone 1.5 Tesla lumbosacral MRI within the last six months
Key exclusion criteria (4 listed)
- The presence of neurological diseases and allergy to local anesthetics
- Refusal to undergo spinal anesthesia
- Contraindications for spinal anesthesia
- Local infection at the lumbar site
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 |
|---|---|---|
| Distribution of spinal anesthetic agentUnder aseptic conditions and in a sitting position, a 25G spinal needle was inserted through the midline at the L₃-L₄ intervertebral space, advancing parallel to the dura fibers. Upon clear cerebrospinal fluid (CSF) flow, the needle bevel was oriented cephalad and 20 mg of 0.5% hyperbaric bupivacaine was injected into the intrathecal space. Patients were kept supine for 5 minutes before sensory block was assessed by pinprick test from the midclavicular line. All spinal anesthesia procedures were performed by the same experienced anesthesiologist. | Procedure or surgery | – |
Primary outcome
The primary outcome was to assess the correlation between lumbosacral CSF volume and peak sensory block level.
Time frame: From enrollment to the end of study 33 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Results publication: PubMed 2007097Stienstra R, Greene NM. Factors affecting the subarachnoid spread of local anesthetic solutions. Reg Anesth. 1991 Jan-Feb;16(1):1-6. No abstract available.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anaesthesia and Magnetic Resonance Imaging (MRI), run by Samsun University 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was to assess the correlation between lumbosacral CSF volume and peak sensory block level. (time frame: From enrollment to the end of study 33 months). 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 NCT07333703, which also lists 1 linked publication.
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 12 Jan 2026.