- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07333703
MRI-Based Estimation of Lumbar CSF Volume and Its Clinical Impact on Spinal Anaesthesia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Samsun, Turkey (Türkiye)
- Samsun University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18-75 years
- ASA physical status I-III
- Who had undergone 1.5 Tesla lumbosacral MRI within the last six months
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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From enrollment to the end of study 33 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SUKAEK-2022/1/14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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