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NCT Number: NCT07497945

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

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

Post-dural puncture headache (PDPH) is a common complication after spinal anesthesia, particularly in patients undergoing cesarean section. It is thought to occur due to cerebrospinal fluid leakage and decreased intracranial pressure.

Optic nerve sheath diameter (ONSD) measured by ocular ultrasound reflects changes in intracranial pressure and may help identify patients at risk for PDPH. This prospective observational study aims to evaluate the predictive value of serial ONSD measurements for the development of PDPH in patients undergoing cesarean section under spinal anesthesia.

Non-invasive bedside ultrasound measurements of ONSD will be performed at predefined perioperative time points. Participants will be followed postoperatively to assess the occurrence of headache.

The results of this study may help improve early identification of patients at risk for PDPH and enhance postoperative management.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Optic Nerve Sheath Diameter Measurement

Other

Participants will undergo non-invasive ocular ultrasound measurement of optic nerve sheath diameter at five predefined time points: preoperatively, 10 minutes after spinal anesthesia, at the end of surgery, at postoperative 24 hours, and at postoperative 48 hours.

Primary outcomes

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

    Time frame: Within 48 hours after spinal anesthesia

    Assessment of the association between optic nerve sheath diameter measurements and the development of post-dural puncture headache.

Study contacts

Contact information is provided by the study sponsor or research team.

Dilara Ayaz Ozcan, MD

CONTACT

[email protected]

+905053932937

Tulay Sahin, MD

CONTACT

[email protected]

+905322825454

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Evaluation of Optic Nerve Sheath Diameter for Predicting Post-Dural Puncture Headache in Cesarean Section Patients: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

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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