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CompletedNCT06957899PDPHPatientsUpdated Dec 9, 2025

Optic Nerve Sheath Diameter in Postspinal Headache

An observational study in Post-Dural Puncture Headache, sponsored by Konya City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Konya City Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 75 Years
Sex
All
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Study summary

This study aims to investigate the relationship between spinal needle size and optic nerve sheath diameter (ONSD) in patients who develop post-dural puncture headache (PDPH) after spinal anesthesia. ONSD is measured using ultrasound, which helps estimate changes in brain pressure. The study also examines whether the severity of headache is related to ONSD. Adult patients aged 18 to 75 years who develop PDPH will be included. This research will be conducted at Konya City Hospital and is expected to last for approximately six months.

Read the detailed description

This prospective observational study investigates the relationship between spinal needle gauge and optic nerve sheath diameter (ONSD) in patients who develop post-dural puncture headache (PDPH) following spinal anesthesia. ONSD is measured using ultrasound as a non-invasive marker of intracranial pressure. The study also aims to evaluate the association between headache severity, assessed by the Visual Analog Scale (VAS), and ONSD values. Patients aged 18-75 years with PDPH will be included, and data on spinal needle gauge, ONSD, and VAS scores will be analyzed. The study is being conducted at a single tertiary care center and aims to contribute to understanding the physiopathology of PDPH and its relation to procedural factors.

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Conditions studied

  • Post-Dural Puncture Headache

Keywords

  • Post-Dural Puncture Headache (PDPH)
  • Intracranial Hypotension
  • Spinal Anesthesia Complication
  • Optic Nerve Sheath Diameter
  • Spinal Needle Gauge
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In context

Post-Dural Puncture Headache

125 studies on the registry are indexed under Post-Dural Puncture Headache; 25 are open to participants now.

This study's enrollment of 40 is below the median of 188 across 34 observational studies indexed under Post-Dural Puncture Headache.

Browse Post-Dural Puncture Headache studies →

Lead sponsor

Konya City Hospital is the lead sponsor of 76 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population consists of adult patients aged 18 to 75 years who develop post-dural puncture headache (PDPH) following spinal anesthesia. All participants are evaluated and monitored at a tertiary care center and are classified as ASA physical status I to III.

Inclusion criteria

  • Patients diagnosed with postdural puncture headache (PDPH)
  • Male and female patients aged 18-75 years
  • Patients classified as American Society of Anesthesiologists (ASA) physical status I-III

Exclusion criteria

Exclusion Criteria:

  • Presence of neurological or ophthalmological disorders
  • History of head trauma within the past 6 months
  • Hypertension
  • Hepatic encephalopathy
  • Renal failure
  • Pregnancy
  • History of chronic headache or migraine
  • Refusal to participate
  • Inability to obtain reliable optic nerve sheath diameter (ONSD) measurements
  • Communication difficulties preventing assessment
  • Incomplete or inaccessible medical records
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 25

    Group 25G: Patients who underwent spinal anesthesia with a 25-gauge needle

  • Group 27

    Group 27G: Patients who underwent spinal anesthesia with a 27-gauge needle

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What researchers measure

Primary outcomes

  1. Optic nerve sheath diameter (ONSD)

    The primary outcome is the measurement of optic nerve sheath diameter (ONSD) via ocular ultrasound in patients who develop postoperative headache attributed to dural puncture. This non-invasive assessment is used to estimate intracranial pressure. The aim is to evaluate whether different spinal needle gauges affect ONSD measurements.

    Time frame: Within 4 hours of anesthesia consultation for postoperative headache

Secondary outcomes

  1. Pain severity assessed by Visual Analog Scale (VAS)

    Pain severity will be scored using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), during the anesthesia consultation conducted for postoperative headache. This measure will be compared with ONSD values.

    Time frame: Within 4 hours of anesthesia consultation for postoperative headache

Other outcomes

  1. Spinal Needle Gauge

    The gauge (diameter in G) of the spinal needle used for the neuraxial procedure will be extracted from anesthesia records. The goal is to assess whether the spinal needle size is associated with ONSD measurements in patients with postoperative headache.

    Time frame: Retrieved from procedure documentation at the time of spinal anesthesia

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Study locations

1 site
  • Konya City Hospital
    Meram, Konya 42020, Turkey (Türkiye)
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References and documents

Publications

  • Wang P, Zhou X, Sheng F, Wang X, Shi C, Feng W. Ultrasonic optic nerve sheath diameter can be used as a diagnostic measure after accidental dural puncture during cesarean section: a case report. BMC Anesthesiol. 2024 Jan 22;24(1):35. doi: 10.1186/s12871-024-02418-8. PubMed 38254029 ↗
  • Dubost C, Le Gouez A, Zetlaoui PJ, Benhamou D, Mercier FJ, Geeraerts T. Increase in optic nerve sheath diameter induced by epidural blood patch: a preliminary report. Br J Anaesth. 2011 Oct;107(4):627-30. doi: 10.1093/bja/aer186. Epub 2011 Jun 21. PubMed 21693468 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06957899
Lead sponsor
Konya City Hospital
Responsible party
Nuran Akıncı Ekinci (MD, Specialist in Anesthesiology, Konya City Hospital) — Principal investigator
First posted
May 6, 2025
Start date
Jul 1, 2025
Primary completion
Sep 30, 2025
Completion
Dec 5, 2025
Last update
Dec 9, 2025

Study contacts

Nuran AKINCI EKİNCİ
study chair · Konya City Hospiital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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