Not Yet RecruitingNot Applicable

Optic Nerve Sheath Diameter for Predicting Post-Dural Puncture Headache in Cesarean Section Patients

Turkey (Türkiye)220 participantsStarted 2026-03-20

Plain-language summary

Some patients develop headache after spinal anesthesia used during cesarean section. This condition is called post-dural puncture headache (PDPH). Early identification of patients at risk may improve patient care. This study evaluates whether optic nerve sheath diameter (ONSD), measured using a non-invasive bedside ocular ultrasound technique, can help predict the development of PDPH. Participants undergoing cesarean section with spinal anesthesia will undergo ONSD measurements at predefined perioperative time points. Participants will be followed postoperatively for the occurrence of headache. The findings may help improve early recognition and management of PDPH.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

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: * Women aged 18 to 45 years * Singleton pregnancy * Planned cesarean section (elective or emergency due to fetal indications) * Spinal anesthesia planned for the procedure * American Society of Anesthesiologists (ASA) physical status II-III * Normal coagulation parameters (INR less than 1.5, platelet count greater than 100,000/mm³) * Ability to provide written informed consent and cooperate with study procedures Exclusion Criteria: * Known ophthalmologic diseases affecting the optic nerve or retina (e.g., glaucoma, optic atrophy) * Active eye infection or recent ocular surgery * Known intracranial pathology affecting cerebrospinal fluid dynamics (e.g., intracranial mass, hydrocephalus, idiopathic intracranial hypertension) * History of stroke or subarachnoid hemorrhage * Hypertensive disorders of pregnancy such as preeclampsia or eclampsia * Contraindications to spinal anesthesia (e.g., coagulopathy, anticoagulant therapy, infection at puncture site) * Allergy to local anesthetics * Conversion to general anesthesia due to failed or inadequate spinal block * Presence of moderate or severe preoperative headache or active primary headache disorders such as migraine

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

Association Between Optic Nerve Sheath Diameter Measurements and Post-Dural Puncture Headache

Timeframe: Within 48 hours after spinal anesthesia

Trial details

NCT IDNCT07497945

SponsorKocaeli University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01-31

Contact for this trial

Dilara Ayaz Ozcan, MD

+905053932937 dlryz96@gmail.com

View on ClinicalTrials.gov More Post Dural Puncture Headache trials