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NCT Number: NCT06957899

Optic Nerve Sheath Diameter in Postspinal Headache

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.

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Key information

Conditions

Post-Dural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Intracranial Hypotension Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya City Hospital

Meram, Konya, 42020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Primary outcomes

  1. Optic nerve sheath diameter (ONSD)

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

    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.

Secondary outcomes

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

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

    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.

Other outcomes

  1. Spinal Needle Gauge

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

    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.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Impact of Spinal Needle Gauge on Optic Nerve Sheath Diameter in Patients With Post-Dural Puncture Headache

Acronym: PDPHPatients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 6, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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