This study aims to investigate the hypothesis that ultrasonographic optic nerve sheath diameter (ONSD) measurement can help predict the development and severity of postdural puncture headache (PDPH) in patients undergoing spinal anesthesia for total knee arthroplasty. PDPH is defined as a headache that worsens in an upright position and improves while lying down.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at using ultrasound to measure the optic nerve sheath diameter as a way to diagnose post-dural puncture headache — could this type of ultrasound measurement be done in my care if I develop a headache after a spinal or epidural procedure?
2Since the trial has already completed, has my doctor seen or reviewed any of its findings, and do those results change how headaches after dural puncture might be identified or managed in my situation?
3Post-dural puncture headache can sometimes be confused with other types of headaches — would discussing this ultrasound-based diagnostic approach help my care team tell the difference more quickly if I have a headache after local anesthesia?
4If I do end up needing a spinal or epidural procedure, what is the estimated risk that I would develop post-dural puncture headache, and how would my doctors currently diagnose and treat it without access to this specific ultrasound technique?
5Are there standard diagnostic tools already in use at this hospital for post-dural puncture headache, and how does the optic nerve sheath ultrasound method studied in this trial compare to what would normally be available to me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.