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Eye ultrasound may spot spinal headache risk

NCT ID NCT07100158

Diagnosis Sponsor: Ankara City Hospital Bilkent Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether measuring the optic nerve sheath with ultrasound can predict postdural puncture headache (PDPH) after spinal anesthesia. 176 adults having knee replacement surgery were scanned before and after the procedure. The goal was to see if changes in nerve sheath diameter could identify who would develop a headache that worsens when sitting or standing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could give doctors a simple, non-invasive way to predict and monitor postdural puncture headache after spinal anesthesia.
What could go wrong
This is a completed diagnostic study, not a treatment trial. The findings may not apply to all patients or settings, and the measurement technique requires training.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

176 people

The number who actually took part.

Started

Aug 2025

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients aged 18 to 65 years undergoing total knee arthroplasty under spinal anesthesia.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age between 18 and 65 years * ASA physical status I or II * Scheduled for total knee arthroplasty under spinal anesthesia * Successful spinal anesthesia with a single attempt using a 27G Quincke spinal needle * Provided informed consent to participate in the study Exclusion Criteria: * History of neurological or central nervous system disorders (e.g., cerebrovascular disease, intracranial hemorrhage, brain tumor) * Ophthalmological disorders * Hypertension * Hepatic encephalopathy * Renal failure * Pregnancy * History of chronic headaches or migraine * Obesity (BMI \> 35 kg/m²) * Alcohol or substance abuse * Psychiatric disorders * Local infection at the injection site * Allergy to local anesthetics * Bleeding diathesis * Requirement for sedation during the procedure * Inability to cooperate postoperatively (e.g., mental retardation, language deficits) * Inability to obtain reliable ONSD measurements

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Conditions

The condition(s) this trial relates to.

Headache headache disorder intracranial hypotension Post-Dural Puncture Headache

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia, local Headache

Contacts and locations

Locations

  • Ankara Bilkent City Hospital

    Çankaya, Ankara, 06800, Turkey (Türkiye)

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