Optic Nerve Sheath Diameter in Postspinal Headache

NCT06957899 | Completed

• 1 other identifier: 2025/38
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Dural Puncture Headache

Keywords

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

Outcome Measures

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.

  Within 4 hours of anesthesia consultation for postoperative headache

Secondary Outcomes (1)

• Pain severity assessed by Visual Analog Scale (VAS)

  Within 4 hours of anesthesia consultation for postoperative headache

Other Outcomes (1)

• Spinal Needle Gauge

  Retrieved from procedure documentation at the time of spinal anesthesia

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Meram, Konya, 42020, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 38254029 BACKGROUND

• 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.

  PMID: 21693468 BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache; Intracranial Hypotension

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nuran AKINCI EKİNCİ

  Konya City Hospiital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Specialist in Anesthesiology

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: May 6, 2025
• Study Start: July 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 5, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-05

Locations

TU (1)