NCT07333703

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

November 21, 2025

Last Update Submit

January 2, 2026

Conditions

Keywords

Spinal AnaesthesiaPeak sensory block levelLumbosacral volumeMRI

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was to assess the correlation between lumbosacral CSF volume and peak sensory block level.

    From enrollment to the end of study 33 months

Interventions

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Aged 18-75 years
  • ASA physical status I-III
  • Who had undergone 1.5 Tesla lumbosacral MRI within the last six months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

January 12, 2026

Study Start

February 1, 2023

Primary Completion

September 1, 2025

Study Completion

November 15, 2025

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations