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

March 23, 2026 updated by: Dilara Ayaz Özcan, Kocaeli University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Kocaeli
      • Köseköy, Kocaeli, Turkey (Türkiye), 41001
        • Kocaeli University Faculty of Medicine Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tulay Sahin, MD
        • Sub-Investigator:
          • Dilara Ayaz Ozcan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of pregnant women aged 18-45 years undergoing cesarean section under spinal anesthesia at Kocaeli University Hospital. Participants who meet the eligibility criteria and provide informed consent will be enrolled.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 48 hours after spinal anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Tulay Sahin, MD, Department of Anesthesiology and Reanimation Kocaeli University Faculty of Medicine Kocaeli, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KU-TF-DAO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared in order to protect participant privacy and confidentiality. Only aggregated study results will be reported in scientific publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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